Associate Director, GCTO-CQM [China]

 

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Job Description

It is critical that, for all our company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The position has a significant impact in achieving those objectives.

Under the guidance of the Regional Director, Clinical Quality Management Leads, the role oversees all CQM activities in the respective country/cluster and responsible to manage a team of CCQMs.

The role is reponsible for Quality Strategy and Training Strategy development for our clinical operation department in China, and requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives.

Qualifications:

• Bachelor's Degree or equivalent in relevant healthcare 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 Management & Improvement.
• Ideally, experience in managing audits and inspections.
• Ideally, experience in coordinating and delivering training sessions.

Skills:

• Superior oral and written communication and leadership skills in an international environment.
• Excellent project management, organizational and prioritization skills.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:R255676

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