Clinical Trials Manager, Clinical Operations (Oncology)

Descrizione 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