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.
- Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.
- 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.
- With oversight manage study start-up, conduct and close-out.
- Assist in the management of CRO's or other outsourcing partners as appropriate.
- Provide input into content and execution of investigator meetings / may present selected topics.
- Provide input into development of CRF.
- Provide input into site selection with coordinated input.
- Aptitude for clinical systems, can do attitude, ability to work across projects/studies.
- Senior stakeholder management and collaboration with partners.
Skills and Requirements:
- Minimum qualification is a bachelors science degree or equivalent is a related discipline.
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.
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.