Clinical Trials Manager
CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
Clinical Trials Manager (CTM), Clinical Operations - Late Phase
Specific Responsibilities and Skills for Position:
The CTM-Late Phase plays a vital role in the successful implementation of important Gilead Sponsored Non-Interventional Studies.
For Gilead Sponsored Non-Interventional Studies (e.g., Post Authorisation Safety Studies, Patient Registries, HCP Survey, Patient Survey, Real World Evidence, Prospective and Retrospective data collection studies):
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
- Must be able to understand, interpret and explain protocol requirements to others
- Maintains study timelines
- Coordinates review of data listings and preparation of interim/final clinical study reports
- Assists in determining the activities to support a project's priorities within functional area
- Contributes to development of RFPs and participates in selection and management of CROs/vendors, investigator/site selection, ongoing coordination of study sites, either directly or via CROs
- May be asked to train CROs, vendors, investigators and study coordinators on study requirements
- Contributes to development of study budget
- Collaborate with colleagues in Clinical Operations, Medical Affairs, Clinical Research, Pharmacovigilance, Real World Evidence, Project/Portfolio Management, Regulatory, Data Science, Quality Compliance and within the U.S. and EU as required ensuring delivery of assigned studies
- May serve as a resource for others within the company for clinical trials management expertise
- Able to examine functional issues from an organizational perspective
- Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development
- May contribute to development of abstracts, presentations and manuscripts
- Under supervision, may design scientific communications within the company
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Travel may be required
Additionally may manage and support the following:
- Investigator Sponsored Research/Collaborative Research studies including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required
- Compassionate Use programs
- Excellent teamwork, communication, decision-making and organizational skills are required
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint and Excel
Experience and Skills:
- At least 5+ years of experience and a BS or BA degree in a relevant scientific discipline
- At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
Experience working at a Sponsor or CRO on interventional and/or non-interventional studies required
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