Clinical Trials Management Associate

Location
Foster City, CA
Posted
Nov 26, 2021
Ref
2667486
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Clinical Trials Management Associate
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


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.

Clinical Trials Management Associate (CTMA) - Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects:
  • Serves as the key operational contact with external investigators and internal stakeholders.
  • Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety implications.
  • Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or Gilead product support are processed in a timely manner and to high quality.
  • Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study remains on track.
  • Maintains efficient collaboration with company's Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.
  • Acts as primary contact for study drug planning and shipping with Materials & Logistics.
  • Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
  • Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
  • Provides monthly study updates to the appropriate internal stakeholders.
  • Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
  • Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
  • In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
  • 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.
  • Organizes and leads review/approval meetings for CO proposal.
  • Actively participates in Clinical Operations Quality Initiatives.
  • Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
  • Performs administrative duties in a timely manner as assigned.


May contribute to Gilead sponsored studies:
  • With supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • May resolve routine monitoring issues.
  • Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection.
  • With guidance from supervisor coordinates CROs or vendors.
  • May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • Interfaces with individuals in other functional areas to address routine study issues.
  • Some 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 2+ year of relevant experience and a BS or BA in a relevant scientific discipline or
  • At least 2+ year 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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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

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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:

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