
Clinical Trials Manager, Clinical Operations (Oncology)
United States - California - Foster CityClinical Development & Clinical OperationsRegularDescrizione del lavoro
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 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.
Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead’s operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need. Clinical Trials Manager, Clinical Operations - Oncology (CTM). We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team.
**This position can be located in Foster City, CA or Parsippany, NJ. This is NOT a remote position***
RESPONSIBILITIES:
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 of CROs/vendors
May be asked to train CROs, vendors, investigators and study coordinators on study requirements
Contributes to development of study budget
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
KNOWLEDGE:
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
SKILLS:
At least 5+ years of experience and BS/BA in a relevant scientific discipline OR
At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
Prior oncology clinical trials experience