CTM Associate - Early Phase
CTM Associate - Early 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
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases
Clinical Trials Management Associate (CTMA)
Specific Responsibilities and Skills for Position:
- Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas
-Under supervision 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
- Under supervision may serve as the key operational contact for Gilead (GS) studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
-May take part in fair market evaluations ISRs in collaboration with Clinical Pricing department
-May participate in coordination and input to periodic safety update reports and development safety update reports when requested
-Communicates and collaborates with Medical Affairs, Clinical Research, Regulatory Affairs, CCF, Clinical Supply Management, and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities
-Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track
-Supports study drug planning and shipping activities
-Ensures all protocol, budget, contract are appropriately approved, executed, and documented.
-Forecasts, tracks and reports CO and ISR milestones and ensures invoice payment.
-Provides monthly study updates to the appropriate internal stakeholders.
-Maintains internal Clinical Operations databases and document repositories
- Must be familiar with routine medical/scientific terminology
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies
- Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports
- May contribute to SOP development
- For GS studies, may monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
- May resolve routine monitoring issues
- Travel may be required
- Responsible for the oversight and management of investigator-sponsored and collaborative studies
- 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 email@example.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:
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