Clinical Trials Manager
The Clinical Trial Manager will be responsible for the management of one or multiple investigational clinical trials (depending on experience), including set-up, site selection and training, vendor management, enrollment and monitoring of adherence to GCP standards and the protocol, data review, and generally all activities related to study execution. The Clinical Trial Manager will interact internally with members of a cross functional study management team, and, externally with vendors (CROs and specialty vendors), investigational sites' personnel, Clinical Research Associates, contractors/consultants, and all other individuals and functions involved in the conduct of clinical operations activities.
Duties and Responsibilities Include But Are Not Limited To:
- Provides management of one or multiple investigational clinical trials (Phase 1 to Phase 3)
- Supervises Clinical Research Associates (CRAs) and/or consultants/contractors as needed including providing guidance/training and reviewing monitoring reports
- As a member of the Study Management Team, works collaboratively to review the clinical protocol(s), authors informed consent forms and study plans and all other study related documents.
- Works collaboratively with Biometrics and Data Management to provide input in the set-up of case report forms, patients diaries and other data collection tools
- Tracks patient enrollment and investigational site updates and issues
- Maintains an inspection-ready GCP compliant Trial Master File
- Manages multiple vendors, including clinical research organizations, central laboratory and specialty vendors (i.e. central imaging review, biomarker assays, etc.)
- Manages drug ordering and supply either internally or through the use of a drug supply vendor and IWRS systems.
- Establishes a project plan/timeline taking into account cross-functional input and monitors against project progress. Recommends and implements alternative solutions to counter study timelines delays. Reviews and ensures compliance with standard operating procedures (SOPs) for Clinical Operations in accordance with ICH/GCP and industry standards.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Must have a demonstrated track record in the field of clinical operations, that includes the management of one or several investigational clinical studies from set-up to database lock and reporting, either in the US alone or in multiple global countries
- Must have a demonstrated track record of vendor management
- Must be flexible and nimble with ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Must possess strong organization and documentation skills, showing effective communication, ability to work in a team-oriented environment and interpersonal skills.
- Must be willing to travel up to 20% of time, including conducting co-monitoring visits, as needed Proficiency with Microsoft Office programs, including Outlook, Powerpoint, Excel, Project plan and Documentum software.
Education and Experience:
- Bachelor's Degree required (oncology experience is preferred).
- Minimum 6 years' relevant industry or clinical research organization (CRO) experience
- This position has an on-site requirement and remote working is not allowed in this role.