Line Manager CRA


General Information
4 Year Degree
Contract to Hire
8 to greater than 15 years
Up to 25%
Job Description

The position will focus of the Trial Execution Success in US. Management of the Clinical Trials Sites with ongoing support, resourcing assistance, training and planning as well as high degree of motivation is key to deliver the future pipeline of our client.

As the Senior CRA’s Manager in US you will have the overall responsibility of managing approx 10 internal CRAs as well as a team of external contract CRAs. The position holds responsibility for the appointed Clinical Sites in the region and is part of the Pharma Global Clinical Operations team.

Roles and Responsibilities:

1. Personnel Management: Responsibility for management, training, and development of CRAs; Responsibility for management, supervision, and training of contract CRAs.

2. Trial Resource Management: Ensure sufficient CRA resource for appointed clinical trials conducted in the Region. Trial sites are typically placed around US and Canada

3. Financial: Budget responsibilities for CRA oversight and sourcing  

4. Therapeutic Background: Be cognizant with therapeutic areas concerning all trials (primarily dermatology).

5. Provision of quality data/documents: Ensure that all clinical trials monitored by client in North America are set up/monitored/managed/closed according to GCP and company SOPs.

6. Investigator Site Selection: Support trial feasibility within North America, primarily US.

7. Acceptance of Delegated Tasks: To optimize overall clinical trial performance, accept delegated tasks from other members of the Global Clinical Operations Leadership Team.

8. Process development/improvement: Support evaluation, improvement and streamlining of site management processes across regions globally.

Job Requirements

Life science degree or equivalent is required 5 years or equivalent direct line management experience, 5+ years as a Senior CRA/LCRA Experience with leading and supporting field based teams Advanced knowledge of CTMS/EDC systems Dermatology experience preferred but also areas as Oncology Hematology could be relevant Solid experience with risk-based monitoring Prior successful interaction with CRO counterparts Management of an external CRO team is preferred or evidence of leading an international team