MSD Senior Clinical Operations Manager 

Vietnam, Ho Chi Minh City 

884895247

Job Description

Responsibilities include, but are not limited to:

• Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up:
• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Interacts successfully with local clinical team/s in order to deliver clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD is an option that can vary per country.
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.
• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
• Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/Int'l SOPs.
• Oversees CTCs and contract workers (e.g. CTCs) and local vendors and may manage COMs, both as applicable.
• Works with minimal oversight from CRD or COM manager in close collaboration internally with Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs,Pharmacovigilance
• Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.
• Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.
• Enters and updates country information in clinical, regulatory, safety and finance systems.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.

Experience Requirements:

• 8 years of experience in clinical research

Educational Requirements:

• Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
• Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience is preferred.

CORE Competency Expectations:

• Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the line manager.
• Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions
• Extensive experience with 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 coordination and organizational skills.
• Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
• Demonstrates leadership behaviours

Behavioural Competency Expectations:

• Problem solving and Process Improvement is essential to this position.
• Ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
• Strong communication and leadership skills.
• Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.
• People management skills (also across countries) will be valued.
• 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 and understanding of cultural differences.
• Fluency in both English and local language.

Current Contingent Workers apply

Hazardous Material(s):

Job Posting End Date:06/01/2024

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