Associate Director, Headquarters Clinical Quality Management - Infectious Disease & Vaccines Job - United States
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, 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.
- Bachelor’s Degree in relevant health care area
- Master’s Degree
- Experience and Knowledge in Quality Management in the Clinical Trial setting, GCP Auditing and GCP Inspections.
- Knowledge of Transcelerate, ICH E6, Rev. 2
- A minimum of 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 the Infectious Disease and/or Vaccines Therapeutic Area, specifically related to design of trials and therapeutic area specific clinical assessments and medical practice.
- Experience developing and delivering effective CAPA management solutions.
- 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 firstname.lastname@example.org.
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Job: Clinical Research Generic
Job Title:Assoc. Dir, Clinical Research
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Clinic, Medical, Manager, CAPA, Healthcare, Management, Research