Sr. Clinical Trials Management Associate, Clinical Operations - Virology

Location
Foster City, CA, US
Posted
Nov 14, 2020
Ref
2076041
Required Education
Associate Degree
Position Type
Full time
Sr. Clinical Trials Management Associate, Clinical Operations - Virology
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.

Sr. Clinical Trials Management Associate, Clinical Operations- Virology (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

- Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for research management

- Provide support and guidance, as required, to Study Management Team personnel responsible for managing studies

- Maintains a good understanding of industry standards for studies and keeps abreast of any new changes and developments which could impact operations

- 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 and 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

- Responsible in 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 study plans as needed

- 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, Project and Excel

Experience and Skills:

-At least 4+ years of experience and a BS or BA in a relevant scientific discipline

-At least 4+ years 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.

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.

To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Clinical-Trials-Management-Associate--Clinical-Operations---Virology_R0016033-1

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