Clinical Trials Management Associate (CTMA) Bioanalytical Operations

Location
94404, Foster City
Posted
Sep 06, 2018
Required Education
Bachelors Degree
Position Type
Full time

Clinical Trials Management Associate (CTMA) Bioanalytical Operations

 

For Current Gilead Employees and Contractors:

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

 

Job Description

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) Bioanalytical Operations

 

Specific Responsibilities and Skills for Position:

- 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 appropriate

 

Knowledge:

- 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 Excel

 

Experience and Skills:

-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 trial

coordinator within a clinical trial setting is a plus

-Clinical or biological/analytical laboratory experience with evidence of involvement in the

processing and/or analysis of biological samples is a plus

 

We are an equal opportunity employer. Apply online today at www.gilead.com/careers.

 

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.

 

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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

 

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For Current Gilead Employees and Contractors:

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

 

To apply, please visit: http://apptrkr.com/1288364

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