Sr. Clinical Trials Manager, Clinical Operations- Oncology
United States - Washington - Seattle, United States - California - Foster CityClinical Development & Clinical OperationsRegularJob Description
Gilead has a rich pipeline of promising medicines across multiple indications in Oncology with numerous submissions and readouts planned through 2025 and beyond. There are >15 active pivotal registrational trials, a robust early-mid phase pipeline, and a myriad of partnerships, collaborations, and opt-ins that require strong Clinical Operations leadership of study management teams and global oversight of trial activities including site and contract resource operations (CRO) partnerships.
**Position is local to Foster City, CA or Seattle, WA. Position is NOT REMOTE.**
Specific Responsibilities and Skills:
- Has advanced knowledge of study management best practices and tools and has shown ability to apply these to improve project efficiencies and effectiveness.
- Has significant industry (ICH/GCP and FDA/EMA regulations) knowledge, including knowledge of drug development, and is able to flex own knowledge to work on studies of varying scope and complexity.
- Contributes review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
- Independently creates and manages budgets and resource plans for assigned studies and other work, seeking advice as needed.
- Responsible for identifying cross-study synergies to leverage efficiencies and ensure consistencies where appropriate.
- Leads moderately complex assignments that enable multiple functions and teams to achieve their clinical study objectives within targeted timelines and allocated resource levels.
- Collaborates with other functions on how to best achieve their clinical goals and objectives.
- Drives accountability and oversight of CRO to ensure the overall program(s) is completed compliantly, on-time, within-budget and to the quality expected.
- Consistently models our Leadership Commitments and Values for others to follow.
- Has the managerial courage to speak-up when needed, and in a manner that moves the business and team forward.
- Gives constructive, fair, balanced, concise and actionable feedback.
- Takes accountability to ensure change is understood and implemented well.
- Effectively influences without authority.
- Ensure study delivery is on time, as per scope and compliance, and within the allocated budget
- Demonstrates ability to think short- and long-term in devising appropriate project strategies and approaches to completing project deliverables.
- Coaches and guides less experienced team members in solving problems. Depending on business need, may manage Clinical Project Assistant/Clinical Trial Management Assistant/Sr. Clinical Trial Management Assistant
Knowledge
- Working knowledge and experience with Word, PowerPoint and Excel
- 7+Years with BA/BS/RN or 5+ Years with MA/MS/MBA/PharmD/PhD
- Prior clinical trials/operations experience in company sponsored clinical trials required
- Prior oncology clinical trials experience