As a Start-Up Team Manager, you will be responsible for executing the Start-Up team activities in clinical trials performed in Israel, ensuring compliance with local regulations, ICH-GCP, procedures and protocol requirements.
In addition, you will have the following responsibilities:
Manage and lead the Start-Up team, set and monitor performance targets and KPIs for the team and functional area in close cooperation with Israels Clinical Development Center (CDC) Director and with the Therapeutic Area (TA) Heads.
Ensure preparation and submission of local Clinical Trial Application to Health Authorities and Ethics Committees (ECs) to obtain all necessary regulatory approvals within defined timelines.
Deliver reliable, high-quality data and ensure study participants protection to activate sites prior to FPFV (First Patient First Visit) in the country.
Manage the lifecycle of clinical trial agreements/contracts, including sub-contractors, across trials.
Execute regulatory submissions of Clinical Trial Applications (CTA) and ongoing submissions and obtaining approvals.
Requirements: B.Sc. in Life Science, Pharmacy/nursing qualification or equivalent, M.Sc. in Life Science would be an advantage.
Basic GCP qualification.
At least 3 years of experience as a Start-Up Team member.
At least 2 years of direct people management-Preferred.
Conceptual and strategic approach to the clinical organization development with strategic insight to trial Start-Up and supporting processes in the clinical trial conduct.
Strong track record in clinical trial execution in multifunctional team at country level, including clinical quality (audits and inspections) and training.
Strong leadership and management skills to build and manage the start-up team.
Excellent communication and collaboration skills to work closely with the CDC Director and with the TA Heads and CQTM.
Experience in executing regulatory submissions of Clinical Trial Applications (CTA) and obtaining approvals.
Fluency in Hebrew and English.
This position is open to all candidates.
