Clinical Research Studies Leader II
A global biotechnology company located in New York City is seeking to hire a Global Studies Leader II for a year-long project. This company is considered the founder of the biotechnology industry and has grown into a leader of break through medical science.
The Global Studies Leader will be responsible for: 1) Planning, coordination, communication, motivation and setting the direction of the study management team, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. 2) Preparing and managing the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking. 3) Conducts protocol and site feasibility assessments to ensure optimal site selection. 4) Contributing to CRO selection activities and contract set-up, serves as primary contact with CRO Project Manager and provides oversight of the CRO, ensures communication between CRO, other vendors and Study Management Team for the entire study lifecycle. 5) Reviewing study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports.
Title: Global Clinical Research Studies Lead
Location: New York, NY
Duration: 12-months-potential to convert FTE
Pay Range: $85-90
- Education Requirement: Bachelor's or Master's degree in a biomedical or life sciences discipline.
- Must have study management experience in clinical or pharmaceutical development & must have 10 years of clinical studies experience within a pharmaceutical setting.
- Working knowledge of international regulatory and ICH GCP guidelines.
- The ideal candidate(s) will have experience in several therapeutic areas.
- He/she must have experience leading Phase I & Phase II studies.
- Some domestic and international travel will be required.
- Global trial experience is highly preferred.
Sthree US is acting as an Employment Business in relation to this vacancy.