Sr. Clinical Trials Manager, Clinical Operations - Early Development

Location
Foster City, CA, US
Posted
Oct 21, 2020
Ref
2027738
Required Education
Bachelors Degree
Position Type
Full time
Sr. Clinical Trials Manager, Clinical Operations - Early Development
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Senior Clinical Trials Manager, Clinical Operations- Early Development (Sr. CTM):

Specific Responsibilities and Skills for Position:

- Must meet all requirements for CTM and have demonstrated proficiency in all relevant areas

- Manages successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, and expanded access programs, and compassionate use programs

- Frequently evaluates scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment

- May present the outcomes of the assessments to proposal review committee members

- Establishes strong partnerships with external investigators, collaborators, and internal stakeholders to ensure efficient execution of the study management processes

- Ensure high quality internal Clinical Operations databases and document repositories

- For GS studies, ability to write study protocols, study reports, and regulatory documents (e.g. IND, NDA, etc.) with little supervision

- In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines

- Communicates with functional peers regarding project status and issues and ensure project team goals are met

- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction

- Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements

- Anticipates obstacles and client difficulties and implements solutions to achieve project goals

- Experience in developing RFPs and selection and management of CROs/vendors

- May contribute to development of abstracts, presentations and manuscripts

- Functional expertise to initiate, author or contribute to SOP development, implementation and training

- Participates in the recruiting and hiring process for CPA/CTMA/Sr CTMA/CTM and supports their professional development

- May manage CPA/CTMA/Sr. CTMA

- Coaches members of a work team and ensures adherence to established guidelines

- Ability to examine functional issues from a broader organizational perspective

- Travel may be required

- Collaborates with local medical affairs colleagues on country specific studies and initiatives

- Provides knowledge and expertise on country specific regulations, offers strategic input for study delivery

- Independently manages all components of complex studies, compassionate use programs and non-interventional studies

- Collaborates with local medical affairs colleagues on country specific studies and initiatives

- Provides knowledge and expertise on country specific regulations, offers strategic input for study delivery

- Independently manages all components of complex studies, compassionate use programs and non-interventional studies

Knowledge:

- 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

- Excellent interpersonal skills and demonstrated ability to lead is required

- Excellent verbal, written, interpersonal and presentation skills are required

Experience and Skills:

- At least 7+ years of experience and a BS or BA in a relevant scientific discipline

- At least 7+ years of experience and an RN (2 or 3 year certificate)

For jobs in the United States:

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Clinical-Trials-Manager--Clinical-Operations---Early-Development_R0015087-1

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