Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
It is critical that, for all company-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.
Qualifications
Bachelor's Degree or equivalent in relevant health care area.
Experience
- 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
- 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, organizational and prioritization 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.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Shift
Valid Driving License
Hazardous Material(s)
Requisition ID R245469
