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.
