Gilead Sciences, Inc. is looking for a Clinical Trials Manager to provide guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. You will be responsible for overseeing operational aspects from study start-up through close-out.
What You'll Do
- Guide and provide daily oversight for international clinical trials to meet budget and timeline goals.
- Communicate with functional peers on project status to ensure team goals are met.
- Oversee clinical trial conduct including study start-up, enrollment, maintenance, and close-out.
- Prepare and contribute to study-related documents such as Clinical Protocols, Informed Consent Forms, and Monitoring Plans.
- Coordinate data review to support interim and final data analysis.
- Participate in study strategy development and maintain study timelines.
- Contribute to the development of study budgets, RFPs, and the selection of CROs and vendors.
- Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
- Manage CRO interactions and sponsor oversight of operational activities.
- Proactively identify potential study issues and recommend solutions.
- Organize internal team meetings, investigator meetings, and other trial-specific meetings.
- May participate in recruiting and hiring for the CTM team and mentor junior members.
- Coach members of a work team and ensure adherence to established guidelines.
What We're Looking For
- A BS/BA degree in nursing, science, or a health-related field with at least 5 years of trial management experience.
- An MS/MA degree in nursing, science, or a health-related field with at least 3 years of trial management experience.
Nice to Have
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
- Proficiency in developing trial plans including site monitoring, risk mitigation, site selection, and clinical supplies management.
- Highly developed leadership skills to lead a clinical study team.
- Ability to deal with time demands, incomplete information, and unexpected events.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, verbal, and written communication skills for a collaborative environment.
- Comfort in a fast-paced environment and ability to adjust workload based on changing priorities.
- Complete knowledge of FDA, EMA, ICH guidelines, GCP, and key Clinical Operations principles.
- Familiarity with standard medical and scientific terminology.
- Ability to communicate clearly, support a team-oriented, highly-matrixed environment, and execute multiple tasks.
- Ability to travel when needed.
Team & Environment
You will partner with a Clinical Program Manager or Associate Director and work in a highly-matrixed environment.
Benefits & Compensation
- Compensation: $146,540.00 - $189,640.00
- Company-sponsored medical, dental, vision, and life insurance plans.
- Discretionary annual bonus.
- Discretionary stock-based long-term incentives.
- Paid time off.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
