We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
It is critical that, for all MSD-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives. Under the guidance of the Regional Director, Clinical Quality Management (RCQM),
the CCQM oversees all CQM activities in the respective country/cluster.
The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.
- Bachelor's Degree or equivalent in relevant health care area.
- Field knowledge in the pharmaceutical industry
- A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
- Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Demonstrated experience in leading cross-functional teams.
- Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
- Ideally, experience in managing audits and inspections.
- Ideally, experience in coordinating and delivering training sessions.
- Superior oral and written communication and leadership skills in an international environment. Excellent project management and organizational skills.
- Excellent teamwork skills, including conflict resolution expertise and discretion.
- Ability to analyze, interpret, and solve complex problems.
- Ability to think strategically, objectively and with creativity and innovation.
- Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Valid Driving License: