Total 18 job vacancies by IQVIA

As you develop your career as a Senior CRA or CRA, this role offers you the opportunity to plan and progress your career in the direction you choose. At IQVIA, we do not believe in a ‘career ceiling.’ You will be exposed to wider opportunities like operations management, dedicated customer solutions, project management and more. And you won’t do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion opportunities and awards. Joining IQVIA will give you access to cutting-edge in-house technology and provide opportunities to work on global projects/ trials. You will be building a flexible, meaningful and fulfilling career with no limits.

Your responsibilities will include:

• Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.

Qualifications:

• University degree in scientific discipline or healthcare
• At least 1 year of on-site monitoring experience
• Good knowledge of GCP and clinical research regulatory requirements
• Good computer skills including MS Office
• Excellent command of English language
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
• Flexibility to travel.

What you can expect:

• Working with different customers on global trials
• Career development opportunities for those who are passionate in wanting to grow as part of the organization.
• Leaders that support flexible work schedules/arrangement
• Excellent working environment in a stable, international, reputable company
• Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape
• Attractive remuneration package.

Responsibilities:

As a Manager at IQVIA, you will be responsible for leading teams in the development & delivery of consulting projects. He/She will also be part of the regional consulting group and will have the opportunity to support larger & more complex projects in the Southeast Asia region.

• Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects.
• Reviews and analyzes client requirements or problems and assists in the development of proposals of cost effective solutions that ensure profitability and high client satisfaction.
• Provides direction and guidance to Analysts, Consultants, and where relevant, to Statistical Services assigned to engagement.
• Develops detailed documentation and specifications.
• Performs qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client specific solutions.
• Designs, structures and delivers client reports and presentations that are appropriate to the characteristics or needs of the audience.
• May deliver some findings to clients.
• Recommends improvements and alternative solutions to resolve problems.
• May identify new business opportunities of follow-on work and new leads at assigned client.
• Provides follow-up with client after project deliverable has been completed to ensure client satisfaction.
• Proactively develops broader and deeper knowledge of related consulting methodologies and life sciences market through on the job experience and participation in training opportunities. Begins to develop CoE specific subject matter expertise.
• When acting as Project Manager, proactively manages project timelines and manages day to day communication with the client and team members.

Skills & Experience

• Bachelor’s degree with more than 8 years of relevant experience in consulting; experience in pharmaceutical and/or healthcare industry will be highly advantageous
• Possesses solid project management skills, client influencing and relationship building skills
• Experienced with developing consultative relationships with senior level managers and executives at clients in the pharmaceutical/healthcare industry
• Ability to manage multiple projects, juggle priorities and deliver on tight deadlines
• Knowledge of consulting methodologies, tools and techniques related to functional area
• Excellent presentation, communication and client influencing skills
• Has necessary subject matter expertise to effectively manage projects within a given practice area.

As an Associate Principal at IQVIA, you will be responsible for managing or leading multiple consulting projects and ensuring on-time and on-budget delivery for clients in life sciences or related industries by:

• Managing project teams, including both internal and external resources in the design, development and delivery of client solutions.
• Leading teams to review and analyze client requirements or challenges and develop associated proposals that ensure profitability and high client satisfaction.
• Managing the process of proposal preparation and/or modifications including overall bid integrity.
• Developing project plan with timelines and deliverables and leading project to successful completion, on-time and on-budget, from start to finish with limited senior management guidance.
• Recommending improvements and alternative solutions to resolve problems.
• Serving as key point of contact with client.
• Providing high level input to, and ensuring the development of, client reports and presentations and delivering all or significant portions of findings to client.
• Developing and/or elevating new business opportunities through the identification of follow-on work and new leads.
• Proactively strengthen subject matter expertise through on the job experience, participation in conferences and symposiums and other forums for professional knowledge sharing.
• Proactively mentor, coach and share subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.

Skills & Experience

• Demonstrable analytical, interpretative and problem-solving skills.
• Well-developed written and verbal communication skills including presentations, chairing meetings, workshop facilitation, business and report writing.
• Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes.
• Experience working in sizable/ multi-disciplined teams and leading staff.
• Experience in developing credible relationships with senior level managers and executives in the life sciences industry.
• Ability to contribute to business development through the identification of leads, development of proposals etc
• Knowledge of key issues and current developments in the life sciences industries.
• Knowledge of consulting methodologies, tools and techniques.
• A strong academic track record, with 8+ years of consulting experience.
• A track record of leadership and people development.

As an Analyst at IQVIA, you will provide high quality, on-time input to client projects in the healthcare/life sciences field. Assignments typically require analysis and problem solving within an established framework.

• Under direct supervision, assists with the review and analysis of client requirements or problems and assists in the development of client solutions.
• Assists in the development of detailed documentation and specifications.
• Under close supervision, performs quantitative or qualitative analyzes to assist in the identification of client issues and the development of client specific solutions.
• Assists in the design and structure of presentations that are appropriate to the characteristics or needs of the audience.
• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.

Skills & Experience

• Bachelor’s Degree / Master’s Degree / PhD holder, with a keen interest in life sciences or healthcare consulting.
• Works willingly and effectively with others in and across the organization to accomplish team goals.
• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.
• Knowledge of current events and developments within an industry and major competitors.
• Effective time management skills.

Responsibilities:

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Build awareness of features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

Requirements:

• Bachelor's degree in a health care or other scientific discipline or educational equivalent.
• Minimum of 1+ years of on-site monitoring experience; or equivalent combination of education, training and experience.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Good written and verbal communication skills
• Good organizational and problem-solving skills
• Effective time management skills

As an Analyst at IQVIA, you will provide high quality, on-time input to client projects in the healthcare/life sciences field. Assignments typically require analysis and problem solving within an established framework.

• Under direct supervision, assists with the review and analysis of client requirements or problems and assists in the development of client solutions.
• Assists in the development of detailed documentation and specifications.
• Under close supervision, performs quantitative or qualitative analyzes to assist in the identification of client issues and the development of client specific solutions.
• Assists in the design and structure of presentations that are appropriate to the characteristics or needs of the audience.
• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.

Skills & Experience

• Bachelor’s Degree / Master’s Degree / PhD holder, with a keen interest in life sciences or healthcare consulting.
• Works willingly and effectively with others in and across the organization to accomplish team goals.
• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.
• Knowledge of current events and developments within an industry and major competitors.
• Effective time management skills.

Responsibilities:

• Under direct supervision, assists with the review and analysis of client requirements or problems and assists in the development of client solutions
• Assists in the development of detailed documentation and specifications
• Under close supervision, performs quantitative or qualitative analyzes to assist in the identification of client issues and the development of client specific solutions.
• Assists in the design and structure of presentations that are appropriate to the characteristics or needs of the audience.
• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.
• Engagement based responsibilities are assigned and closely managed by Consultants, Senior Consultants, Engagement Managers or Principals.

Skills and Abilities

• Works willingly and effectively with others in and across the organization to accomplish team goals.
• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.
• Knowledge of consulting methods, tools and techniques, related to one’s functional area.
• Knowledge of current events and developments within an industry and major competitors.
• Knowledge and understanding of the marketplace. Knowledge of professional/trade associations, key people and companies.
• Effective time management skills

Job Summary:

Project Management & Regulatory and Start-up is a growing business in IQVIA’s clinical CFSP business. In our CFSP Models, Clinical Project Manager (CPMs), focused on project delivery and Regulatory and Start-Up Specialists (SSUs) focused on the delivery of the start-up phase of clinical trials, will follow customer SOPs, systems, and processes for delivery, with oversight from either IQVIA Line management (managed model) or customer line management (pastoral model). This role is for a Center of Excellence (COE) for CFSP PM & RSU.

Job Responsibilities:

Oversight of the project management function for CFSP APAC, which includes development of project management competency framework, direct line management and growing the business to achieve revenue target.

• Direct line management of in-sourced CPMs which includes obtaining regular feedback from key stakeholders to assist in personal and professional development of the CPMs. May attend project team meeting to support development needs. Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps.
• Proactively manage risks linked to resourcing, model and/or individual needs with other management and leadership team members to manage model issues and obstacles.
• May lead and/or actively participate in corporate initiatives act as a department cross-functional liaison and/or change agent. Provide technical expertise and project management experience.
• Build a Center of Excellence for the CFSP APAC PM function
• Work with CFSP Global and regional operations leads, country operations leads and business development team to grow the project management business in CFSP APAC.
• Proactively develop and/or elevate new business opportunities for APAC.
• Serves as the single point of contact for the Regulatory and Start-function in clinical CFSP APAC.

Job Requirements:

• Bachelor's Degree in Life Sciences or related field required.
• 8 years of clinical trials experience including experience in a leadership capacity.
• In depth knowledge and skills in applying applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong understanding of Clinical Research industry and the relevant environments in which it operates.
• Demonstrates excellent project management skills and client influencing and relationship building skills.
• Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions.
• Effective leadership, mentoring and training skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Good judgment and decision-making skills.
• Strong communication and presentation skills.
• Strong organizational and problem-solving skills.
• Demonstrated learning agility and openness to learning and keeping own knowledge and skillset current and evolving.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Strong software and computer skills, including MS Office applications.

As an Associate Principal at IQVIA, you will be responsible for managing or leading multiple consulting projects and ensuring on-time and on-budget delivery for clients in life sciences or related industries by:

• Managing project teams, including both internal and external resources in the design, development and delivery of client solutions.
• Leading teams to review and analyze client requirements or challenges and develop associated proposals that ensure profitability and high client satisfaction.
• Managing the process of proposal preparation and/or modifications including overall bid integrity.
• Developing project plan with timelines and deliverables and leading project to successful completion, on-time and on-budget, from start to finish with limited senior management guidance.
• Recommending improvements and alternative solutions to resolve problems.
• Serving as key point of contact with client.
• Providing high level input to, and ensuring the development of, client reports and presentations and delivering all or significant portions of findings to client.
• Developing and/or elevating new business opportunities through the identification of follow-on work and new leads.
• Proactively strengthen subject matter expertise through on the job experience, participation in conferences and symposiums and other forums for professional knowledge sharing.
• Proactively mentor, coach and share subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.

Skills & Experience

• 5+ years of healthcare consulting experience, or 8+ years of general consulting experience.
• Well-developed written and verbal communication skills including presentations, chairing meetings, workshop facilitation, business and report writing.
• Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes.
• Experience working in sizable/ multi-disciplined teams and leading staff.
• Experience in developing credible relationships with senior level managers and executives in the life sciences industry.
• Excellent interpersonal skills and ability to work effectively with others in and across the organization to accomplish team goals.
• Ability to contribute to business development through the identification of leads, development of proposals etc
• Knowledge of key issues and current developments in the life sciences industries.
• Knowledge of consulting methodologies, tools and techniques.
• Demonstrable experience in and commitment to the life sciences and/or healthcare industries.
• A track record of leadership and people development.
• Fluency in English (spoken and written).
• A willingness and ability to travel for work.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Job Overview
•Manages the marketing plan for either a specific offering or part of offerings within Information and Analytics and/or Consulting and Services targeted for a specific marketing audience.

Essential Functions
• Manages all marketing related activities for an offering(s) including: short and long-term planning, sales support and promotions to contribute to client satisfaction with the product; market research activities, providing input into the development and execution of the offering(s) in the annual Marketing Plan; gathering competitive intelligence to ensure product superiority and customer satisfaction; marketing promotion functions, and pricing development that contributes to the long term success of the offering(s).
• Serves as offering(s) expert for the customer and sales organization, and provides support at client meetings.
• Provides input into business cases regarding the definition of new offerings and line extensions. May mentor less experienced colleagues.

Essential Functions

• Responsible for performing and documenting analytical procedures in accordance with company procedures and regulatory guidelines.
• Assists in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times to include, updating standard procedures, assisting with troubleshooting.
• Acts as a technical resource for laboratory staff and support the team in the absence of the line manager.
• Performs routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
• Prepares data analysis results for upload to LIMS system under the guidance of senior level staff.
• Contributes to CAPA investigations, deviations, and resolution.
• Responsible for clear, accurate, and timely communications with cross functional stakeholders.
• Assists in maintaining laboratory equipment and may offer suggestions for new equipment.
• Assists in good housekeeping of the lab environment, consistent with 6S standards.
• Assists in maintaining adequate inventory.
• Responsible for preparation of buffers and solutions for analysis, as required.
• Performs and documents calibration and maintenance of laboratory equipment as assigned.
• Performs and documents hands on training for other lab personnel in areas of proven competency as assigned.
• Participates in continuing education through self-study, attending training sessions and  lectures and meetings.
• May lead a laboratory or cross functional projects and assist with implementation of changes.
• May be responsible for contributing to the design and development execution of routine methods/assays under moderate supervision.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements.

Qualifications

• Bachelor's Degree in any healthcare-related fields.
• Sound knowledge of principles, theories, and concepts in Anatomic Pathology, with at least 1.5 years of relevant laboratory skill-set exposure.
• Working knowledge of any applicable regulatory standards within area of responsibility.
• Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling ,
• Strong technical knowledge of complex testing procedures and science supporting the analysis.
• Proficiency with complex laboratory calculations regarding batches and specimens.
• Ability to troubleshoot laboratory equipment and resolve process issues.
• Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

The Opportunity

IQVIA’s Real World Solutions is currently recruiting for an Associate Consultant, Biostatistician/ Epidemiologist to focus on real world evidence generation across APAC region. The successful applicant will have the opportunity to work with experienced healthcare industry, academic researchers, consultants, and data scientists. He/she will support the design, development, and delivery of a wide range of projects to our clients from database analytics, HEOR and patient centered research. Projects range in complexity from evaluating and scoping opportunities, research analysis and problem solving to assisting the development of recommendations for clients.

Responsibilities:

• Develop and execute statistical analyses for real world studies

• Work closely with project teams including project managers, epidemiologists, data scientists, statisticians and consultants across APAC and other regions to ensure accuracy and validity of data

• Maintain in-depth understanding of real-world designs and statistical methods including modeling approaches

• Provide statistical input in study protocols and prepare statistical analysis plan

• Support data analytics scripting and execution of analytics for observational research studies

• Use statistical programming ability to support development/maintenance of central analytics code library and updating existing coding with support from IQVIA data scientists

• Support project delivery including creating reports, presentations and other client deliverables, and participating in client meetings and workshops

• Develop and implement strategies to ensure accurate and timely delivery of statistical analysis results

• Excellent communications skills to effectively communicate complex statistical concepts to internal and external stakeholders

Skills & Experience Required:

• MPH, MSc or PhD (or an equivalent degree) in statistics, biostatistics, epidemiology, public health, or a related discipline

• Proficiency in the use of statistical software such as R and other statistical programming language

• Strong analytical and problem-solving mindset along with excellent written and verbal communication skills

• Compelling quantitative skills with the ability to learn and apply analytical tools and techniques for analysis

• Experience in designing and executing retrospective epidemiological studies using existing data sources

• Prior healthcare-related experience and computing skills with high level programming languages will be an added advantage

• Able to work independently in a multidisciplinary and culturally diverse team

• Excellent team player and self-motivated

• Fluency in English (spoken and written)

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Job Overview
The Quality Specialist is responsible to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the management and the relevant Head(s) of assigned business lines. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Essential Functions

• Adopt and implement the global Quality Management Plan within the scope of the assignment; this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs.;
• Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed, as required by the applicable SOPs.
• Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
• Upon agreement the line manager: Perform any other reasonable tasks as required by the role.;

Qualifications

• Bachelor's Degree in Life Sciences or related field
• 3 - 5 years of prior relevant experience.
• Sound working knowledge of medical terminology, IQVIA standard operating procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge Pharmaceutical industry operations.
• Good organizational, interpersonal and communication skills. Good judgement and decision-making skills.
• Strong influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem solving skills.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.

Responsibilities:

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Build awareness of features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

Requirements:

• Bachelor's degree in a health care or other scientific discipline or educational equivalent.
• Minimum of 1+ years of on-site monitoring experience; or equivalent combination of education, training and experience.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Good written and verbal communication skills
• Good organizational and problem-solving skills
• Effective time management skills

Job Overview

• Recognized master in professional discipline responsible for implementing strategic goals and developing and implementing new products, processes, standards or operational plans intended to achieve functional goals.
• Significantly improves on existing processes and practices and communicates and collaborates with executive leadership.

Essential Functions

• Has in depth understanding of all IQVIA's offerings across functional areas and geographies.
• Responsible for managing the relationship for various clients within an industry or technical specialty and has frequent contact with client senior level managers.
• Contributes to the growth of the business and opportunity identification in the area of specialty via methodology development & innovation for highly complex proposals and presentation of the methodology to potential or existing clients.
• Responsible for providing Advanced Analytics resource to support revenue delivery in the designated business area(s).
• Responsible for billable utilization targets.

Qualifications

• Master's Degree Statistics, Mathematics, Information Technology, Bio-informatics or related field Or
• Ph.D. Statistics, Mathematics, Information Technology, Bio-informatics or related field
• 11+ years of professional experience

As a Principal at IQVIA, you will be responsible for working directly with clients to provide value added input, to develop business opportunities that will lead to additional starbursts and to deliver projects built around strategic issues. Your paramount duty lies in ensuring an elevated level of client satisfaction. You typically operate within a specific Center of Excellence (CoE) domain, but your purview may extend across multiple areas of expertise and clientele.

• Assuming the principal ownership of client engagements, bearing the ultimate responsibility for client contentment and the delivery of superior quality and value.
• Meeting or surpassing designated revenue goals through the development and delivery of insightful, value-driven solutions addressing intricate client challenges.
• Taking charge of making a significant and measurable impact on clients through all engagements.
• Proactively identifying new revenue prospects among existing and potential clients, ensuring a continuous influx of business from client interactions.
• Leading the development of proposals to ensure they are actionable, on-point, and timely for clients.
• Managing client interactions and ensuring the project team achieves efficient and effective project delivery.
• Serving as a solutions-oriented authority, both internally and externally, by applying consultative problem-solving expertise.
• Identifying industry and client-centric issues of significance and collaborating with CoE Leaders and/or Geographic Leaders to forge tangible and commercially viable offerings.
• Enhancing awareness of IQVIA in the marketplace through engagements such as speaking at events, client meetings, publications, and more.
• Actively fortifying your subject matter expertise through hands-on experience, participation in conferences, symposiums, and other professional knowledge-sharing platforms.
• Proactively mentoring, coaching, and sharing subject matter expertise with others to elevate our capacity to deliver world-class solutions for clients.

Requirements:

• 10+ years of experience in the life sciences or consulting industry.
• Demonstrable aptitude in analytical, interpretative, and problem-solving skills.
• Proficiency in written and verbal communication, including presentations, chairing meetings, facilitating workshops, and business and report writing.
• Strong capabilities in managing large-scale or multiple projects, adeptly prioritizing to meet deadlines while consistently delivering high-quality outcomes.
• Experience in leading sizable and multidisciplinary teams.
• A track record of developing credible relationships with senior-level managers and executives in the healthcare/life sciences industry.
• Outstanding interpersonal skills, enabling effective collaboration within and across the organization to achieve team objectives.
• A knack for contributing to business development through lead identification and proposal development.
• Knowledge of key issues and contemporary developments in the life sciences sector.

Essential Functions

• Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory guidelines.
• Performs routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
• Prepares data analysis results for upload to LIMS system under the guidance of senior level staff.
• Assists in quality investigations, deviations, and resolution.
• Prepares buffers and solutions for analysis, as required.
• Assists in the review and update of laboratory procedures and techniques.
• Guides entry level staff on routine procedures and supports on-boarding of new staff.
• Performs and document calibration and maintenance of laboratory equipment as assigned.
• Performs and documents hands on training for other lab personnel in areas of proven competency as assigned.
• Assists in the review and development of laboratory procedures and techniques.
• Assists in the implementation of procedural changes as assigned.
• Notifies inventory staff of supply shortages.
• May represent lab team on cross functional projects.
• Responsible for clear, accurate, and timely communications with cross functional stakeholders.
• Participates in continuing education through self-study, attending training sessions and lectures and meetings.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements.

Qualifications

• Bachelor's Degree in healthcare-related fields.
• At least 6 months - 1 year of experience in a regulated laboratory environment.
• Requires basic knowledge of assigned technical area (Flow Cytometry), systems and procedures obtained through prior work experience - Cytek / BD Facs / Thermo, etc
• Demonstrates understanding of functional area and responsibilities.
• Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP).
• Proficiency with relevant laboratory techniques.
• Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
• Experience working with automation or specialized laboratory equipment.
• Proficiency with routine and some non-routine laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
• Good computer skills using Microsoft Outlook, Word and Excel.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy.
• Ability to effectively collaborate with internal stakeholders.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Responsibilities:

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

• Build awareness of features and opportunities of study to site.

• Collaborate and liaise with study team members for project execution support as appropriate.

Requirements:

• Bachelor's degree in a health care or other scientific discipline or educational equivalent.

• Minimum of 1+ years of on-site monitoring experience; or equivalent combination of education, training and experience.

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

• Good written and verbal communication skills

• Good organizational and problem-solving skills

• Effective time management skills

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com