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Associate Director, Headquarters Clinical Quality Management- Oncology

Merck


Location:
Upper Gwynedd, PA
Date:
07/20/2017
2017-07-202017-08-19
Job Code:
CLI005835
Merck
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Job Details

Job Title: Associate Director, Headquarters Clinical Quality Management- Oncology  - CLI005835

Description
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
 
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
 
Under the guidance of the Director, Headquarters - Clinical Quality Management (HQ-CQM), the Associate Director, HQ CQM will oversee clinical quality management within the Therapeutic Areas supporting Clinical Trial Teams (for in or outsourced trials) to proactively embed quality into Merck sponsored trials, ensure adequate vendor oversight for outsourced trials and address any quality issues as needed. 

The incumbent will be responsible for the development of Quality Plans to implement Quality by Design within Clinical Development Programs, using a risk based approach and collaborating in implementing, and executing of the Quality Control activities at Headquarters (e.g. through central monitoring) as well as in the GCTO countries (e.g. targeted QCVs at selected sites). 

The incumbent will work with employees from all areas within and outside GCTO and will manage and/or co-lead key initiatives charged with executing the continuous improvement initiatives within Clinical Research.



Qualifications
Education: 
  • Bachelor’s Degree in relevant health care area; Master’s Degree preferred

Required: 
  • Experience and Knowledge in Quality Management in the Clinical Trial setting and Risk Assessment/Management. 
  • Knowledge of Transcelerate, ICH E6, Rev. 2
  • A minimum of  ten (10) years of relevant experience in clinical research including liaising with field staff and experience or management/oversight of such individuals, with a demonstrated record of accomplishments. 
  • Knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools is required.
  • Experience in Oncology Therapeutic Area, specifically related to design of trials and therapeutic area knowledge. 
  • Experience developing and delivering effective CAPA management solutions.

Preferred:
  • Superior oral and written communication skills in a global environment. 
  • Excellent project management and organizational skills. 
  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. 
  • Ability to leading cross-functional teams of business professionals.
  • Ability to analyze, interpret, and solve complex problems. 
  • Ability to think strategically and objectively and with creativity and innovation. 
  • Ability to proficiently interact with all levels of management and exert influence to achieve results.

Our employees are the key to our company’s success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  If you need an accommodation for the application process please email us at staffingaadar@merck.com.
  
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
 
Visa sponsorship is not available for this position.
 
For more information about personal rights under Equal Employment Opportunity, visit:
 
           
           
J72017


Job Clinical Research Generic

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-MA-Boston, NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 3

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