CTM Associate/Sr CTM Associate

Location
Foster City, CA
Posted
Jul 24, 2021
Ref
2380275
Required Education
Bachelors Degree
Position Type
Full time
CTM Associate/Sr CTM Associate
China - Hong Kong

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


Overview

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 of more than 13,000 people 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 23 marketed products that are benefiting millions 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.

Today, Gilead's research and development effort is the largest it has ever been evaluating compounds with the potential to become the next generation of innovative therapies for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. The commercial success of Gilead's portfolio of 23 products has provided the company with the vital resources to support the development of new therapeutic advancements.

Working at Gilead provides you with plenty of opportunities for career advancement in a growing and agile environment while working with highly respected teams.

We would like to invite you to be a part of an organization that has helped millions of people around the world live healthier and more fulfilling lives.

This position

The position is responsible for execution of all phase 1-4 clinical trials, across all therapeutic areas, in Asia Pacific region in partnership with global/regional clinical operations team and other relevant functions, reporting to the Associate Director, Clinical Operations.

Job Description

Essential Duties and Job Functions
  • Partners with Clinical Trials Manager to manages geographical region(s) of a large complex clinical trial and independently manages all components of a small less complex study and phase 1 studies
  • Manages vendors and maintains cross functional study timelines in partnership with global study team
  • Works with study team and CRO to troubleshoot country/site specific operational issues
  • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
  • Must be able to understand, interpret and explain protocol requirements to others
  • Coordinates review of data listings and preparation of interim/final clinical study reports
  • May be asked to train CROs, vendors, investigators and study coordinators on study requirements
  • Establishes good relationship with key institutions and key opinion leaders (KOLs) in the region
  • Conducts co-monitoring/oversight and relationship building visits in the region as required
  • Contributes to development of study budget and ensures effectiveness of site budget/contract process in the region
  • Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
  • Participates in departmental, or interdepartmental, strategic initiatives under general supervision


Requirements
  • BS or BA in a relevant scientific discipline or above
  • At least 3+ years of working experience as Clinical Research Associate/ at least 5+ year of working experience as Clinical Research Associate for senior position
  • Must have 3+ years of site monitoring experience in Hong Kong and/or Asia countries and experience in managing Oncology studies is a definite advantage.
  • Thorough knowledge of FDA/Asia Regulatory Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Prior experience in working in both pharmaceuticals and CROs is preferred
  • Excellent teamwork, communication, decision-making and organizational skills are required
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Must have excellent communication skills in English and Chinese (including Mandarin)
  • International and regional travel is required (approximately 10-20%)


Gilead Core Values
  • Integrity (Doing What's Right)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)
  • Inclusion (Encouraging Diversity)


Equal Opportunities

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. It is also Gilead's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster


For Current Gilead Employees and Contractors:

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