Clinical Study Manager
Proclinical is currently recruiting for a Clinical Study Manager with a pharmaceutical company located in Collegeville, PA.
- In house/outsourced studies, multi-country late phase study management
- Accountable to ensure all relevant studies follow SOPs and GCP.
- With direction, matrix with key study conduct partners.
- Assist with maintaining relationships and monitor performance of CRO's and other vendors.
- With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies.
- Manage sites/countries transitioning from study to commercial supplies either via CROs or via LOCs.
- Manage study budgets
- Escalate issues as needed to the Clinical Investigational Lead/medical monitor.
- Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
- Assist in the management of CRO's or other outsourcing partners as appropriate.
- Aptitude for clinical systems, can do attitude, ability to work across projects/studies.
- Senior stakeholder management and collaboration with partners.
- The focus of this role is to work together with external stakeholders to deliver clinical operations activities and documentation in preparation for regulatory submissions following the successful early termination of the pivotal registration study.
Skills and Requirements:
- Bachelor's degree in the life sciences
- Clinical trial / study management experience
- Clinical operations or project management experience
- Pharmaceutical / CRO experience
- Experience in the HIV therapeutic area is preferred, however not required.
- Global study experience preferred.
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.