Clinical Trials Manager to support the lung and thoracic area within our oncology pipeline.
Responsibilities
Coordinating and supervising all aspects of a clinical study.
Monitors clinical trial sites.
Assists Clinical Program Manager in overall study management.
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
Maintains study timelines.
Contributes to development of study budget.
Contributes to development of RFPs and participate in selection of CROs/vendors.
Manage CROs/vendors.
Coordinates review of data listings and preparation of interim/final clinical study reports.
May contribute to development of abstracts, presentations, and manuscripts,
Ensures effectiveness of site budget/contract process.
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
Assists in determining the activities to support a projectβs priorities within functional area.
Under supervision, may design scientific communications within the company.
Qualifications
5+ years of experience and a BS or BA in a relevant scientific discipline required OR
3+ years of experience and a MS in a relevant scientific discipline
Education
BS or BA in a relevant scientific discipline (required) or MS with related experience.