Clinical Trial Management Associate (CTMA) Bioanalytical Operations
Clinical Trial Management Associate (CTMA) Bioanalytical Operations
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
- Must meet all requirements for Clinical Project Associate (CPA) position in relation to bioanalytical sample analysis and must have demonstrated proficiency in all relevant areas- Serves as the key bioanalytical operational contact with internal and external stakeholders, for successful implementation of bioanalytical strategy in Gilead (GS) and Collaborative (CO) programs- Participate in multiple Phase 1-3 teams to manage bioanalytical implementation in clinical trials- Plans and coordinates operational activities required with the collection, delivery and analysis of bioanalytical samples within a clinical trial- Provides sample management expertise to the Study Management Teams (SMTs)- Accountable for ensuring bioanalytical samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.- Coordinate with bioanalytical vendors and Bioanalytical Chemistry staff to ensure bioanalytical sample long term stability to cover clinical trial samples- Coordinate with bioanalytical vendors for bioanalytical sample storage and disposal- Collaborate with bioanalytical partners to translate sample processing and handling instructions from research setting to the clinical setting- Primary interface for operational activities between the SMT and bioanalytical laboratory vendors; provides the day-to-day operational management of bioanalytical vendors to ensure delivery against contracted scope of work- 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 oral presentations as applicable- 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 with the setting and updating of study timelines- Participate in departmental, or interdepartmental, strategic initiatives under general supervision- Participate in vendor visits and provide site training, as needed under general oversight- Assist Gilead partners to ensure that the site complies with the protocol and regulatory requirements for GS studies- Review of protocols, informed consent forms, and relevant study documents, as appropriateKnowledge:
- Excellent verbal, written, interpersonal and presentation skills are required- Knowledge of relevant FDA and/or EMA Regulations and Guidances (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies- Working knowledge and experience with Word, PowerPoint and ExcelEducation:
-At least 1+ years of experience and a BS or BA in a relevant scientific discipline (eg. Clinical Operations and/or Sample Management) or-At least 1+ years of experience and an RN (2 or 3 year certificate)-Pharmaceutical industry experience or experience working as a clinical trialcoordinator within a clinical trial setting is a plus-Clinical or biological/analytical laboratory experience with evidence of involvement in theprocessing and/or analysis of biological samples is a plus
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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.
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