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Senior Clinical Trials Management Associate, Clinical Operations - Late Phase

Employer
Gilead Sciences, Inc.
Location
Foster City, California
Salary
See job description.
Closing date
Jul 16, 2021

View more

Sector
Pharmaceutical, Clinical Manager/ Director
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Senior Clinical Trials Management Associate, Clinical Operations - Late Phase
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. Gileads 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 companys five core values. Thats 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

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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 Operations 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.

Senior Clinical Trials Management Associate- Late Phase (Sr. CTMA)

Specific Responsibilities and Skills for Position:
  • Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas
  • Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs
  • Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management
  • Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies
  • Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations
  • Assist the CTM to organize and lead review/approval meetings for CO proposal
  • Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
  • Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
  • Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams
  • Able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Develop a general understanding of functional issues and routine project goals from an organizational perspective
  • Participate in abstract presentations, oral presentations, and manuscript development activities
  • Interact and cooperate with individuals in other functional areas to address routine study issues
  • Develop tools and processes that increase measured efficiencies of the project
  • Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
  • For GS studies, assist in selecting Contract Research Organizations (CROs) or vendors
  • Assist with the setting and updating of study timelines
  • Participate in departmental, or interdepartmental, strategic initiatives under general supervision
  • Assist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • Conduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visits
  • Ensure that the site complies with the protocol and regulatory requirements for GS studies
  • For GS studies, draft and coordinate review of protocols, informed consents, case report forms, and monitoring plans
  • Travel may be required


Knowledge:
  • Excellent verbal, written, interpersonal and presentation skills are required
  • 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 4+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
  • At least 2+ years of experience and a Masters' degree or higher; scientific discipline preferred

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.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Senior-Clinical-Trials-Management-Associate--Clinical-Operations---Late-Phase_R0018047-1

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