Clinical Trials Manager - Massachusetts Biopharma Company

My client is a biopharma company that develops a range of drugs including anticancer therapeutics.

We are currently looking to appoint a motivated Clinical Trials Manager to join our Massachusetts-based Clinical Development department. The qualified candidate will be responsible for running and closing out our Phase I studies.

Primary responsibilities include:

-Ensure the execution of assigned clinical trials in accordance with study protocol, GCP/ICH, regulatory, requirements and Clinical Standard Operating Procedures
-Plan and run Site Initiation Visits
-Coordinate and provide oversight to site contracting and budgeting process
-Develop and manage timelines for assigned clinical trials
-Ensure CRAs assigned to trial are trained on protocol and relevant SOPs. -
-Review protocols and clinical development documents with regard to feasibility and logistics of implementation
-Evaluate and manage CROs as applicable

Job Requirements:
The qualified candidate will possess a RN/BA/BS with a minimum of 5 years experience in clinical research including 3 years of study management.

-Ideally a strong background as a CRA with experience in study monitoring.
-A thorough understanding of FDA, ICH and GCP guidelines as well as excellent communication skills.

This is an excellent long-term career opportunity to work in a cutting-edge environment, backed up by a generous rewards package. Please contact Craig Brown at Real Pharma on 212-707-8499.

(Real Resourcing acts as an Employment Agency and an Employment Business)