Job Duties:

The Clinical Operations Manager (COM) is accountable for execution and oversight of local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.

• Ownership of study budgets. Responsible for development, negotiation and completion of study agreements. Oversight and tracking of clinical research-related payments
• Execution and oversight of clinical trial submissions and approvals development and translations of local language materials including local language materials
• Managing country deliverables, timelines and results for assigned protocols to meet country commitments
• Works in close collaboration with internal parties and externally with vendors and sites, IRB/IECs and Regulatory Authorities
• Oversight and coordination of local processes including clinical and ancillary supplies management, archiving and retention requirements,insurance process management, etc.

 Requirements: 

• Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
• 3-7 years clinical research experience
• Extensive experience in clinical project management and coordination.
• Expertise of core clinical, regulatory and financial systems, tools and metrics.
• Extensive knowledge of local regulatory environment and submission and approval processes.
• Strong communication and leadership skills.
• Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.
• The ability to focus on multiple deliverables and protocols simultaneously is essential.
• Ability to work effectively also in a remote virtual environment with a wide range of people.
• Strong coordination and organizational skills.
• Fluency in both English and local language.
• Strong problem solving and process improvement skills

Successful candidate will be offered attractive salary, generous fringe benefits and excellent career prospects.  Please send your resume in confidence to the Human Resources Department, Merck Sharp & Dohme (Asia) Ltd., 27/F, Caroline Centre, 28 Yun Ping Road, Causeway Bay, HK or email to hk_human_resources@merck.com.

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our work is someone's hope - everyday at MSD is a challenging and inspiring journey of discovery. Come to join us if you share the same values as ours!