Clinical Trials Manager, Clinical Operations- Oncology
United States - Washington - Seattle, United States - New Jersey - Parsippany, United States - California - Foster City
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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 offer 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 life 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.
Specific Responsibilities and Skills for Position:
- 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.
- 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.
Experience and Skills:
- At least 5+ years of experience and BS/BA in a relevant scientific discipline.
- At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred.
- Prior oncology clinical trials experience.
The salary range for this position is: $143,225.00 - $185,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
For additional benefits information, visit: Benefits Information
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
#J-18808-Ljbffr
