Total 6 job vacancies by Iqvia Rds East Asia Pte. Ltd.

The Manager, Site Activation is responsible for delivery and manage a team of employees responsible for executing site activation activities in Singapore and Malaysia.

• Manages staff's delivery of site activation activities in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development, rewarding and disciplining employee, and addressing employee relations issues and resolving problems.
• Participate in the selection process for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained.
• Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
• Participate, as required, in the allocation of resources to clinical research projects by assigning staff based on their experience and training.
• Manage the quality of assigned staff's work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
• Responsible for leading moderate improvements of processes, systems or products to enhance performance of the job area.
• Problems faced are difficult, and may require understanding of broader set of issues.
• Understands and demonstrates management approaches such as work scheduling, prioritizing , coaching and process execution.

Qualifications

• Bachelor's Degree Scientific discipline or health care preferred.
• Typically requires a minimum of 3 -7 years of prior relevant experience
• Good knowledge and ability to apply GCP/ICH and applicable regulatory guidelines and applicable regulatory guidelines.
• Strong leadership skills, with ability to motivate, coach and mentor.
• Good written communication, including regulatory and/or technical writing skills.
• Good interpersonal skills and strong team player. Able to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Thorough understanding of regulated clinical trial environment and knowledge of drug development process

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:

• 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 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.

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