The Local Study Associate Director / Clinical Project Manager will lead Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with the Sponsors' procedural documents. This is a fully remote role, with very minimal travel required to cover or assist CRA in other monitoring visits if required.
- Leads the performance of the Local Study Team at country level
- Ensures clinical and operational feasibility assessment of studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites
- Performs initial Site Quality Risk Assessment
- Ensures timely submission of application/documents to EC/IRB at start up Ensures timely preparation of country financial Study Management Agreement Plans and coordinates applicable local drug activities (from local purchase to drug destruction).
- Reviews monitoring visit reports
- Organizes regular Local Study Team meetings on an agenda driven basis
- Develops, maintains and reviews risk management plan on country study level: Communicates and co-ordinates regularly with National Co-ordinating
- Plans and leads National Investigator meetings, in line with local codes
- Participates in training and coaching new members of the Local Study Team
- Ensures completeness of the eTMF
- Plans and leads activities associated with audits and regulatory inspections
- Ensures compliance with Code of Ethics
- Collaborates with local Medical Affairs team.
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
- Minimum 3 years of experience in Development Operations (CRA, SCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Good negotiation skills.
- Good medical knowledge and ability to learn relevant Therapeutic Areas.
- Excellent understanding of the Clinical Study Process including monitoring.
- Good resource management skills.
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