Clinical Operations Manager

2 weeks ago

Midrand, Gauteng, South Africa MSD Full time

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the Sr.

Clinical Operations Manager, Head COMs or Clinical Research Director, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.


Responsibilities include, but are not limited to:

  • Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
  • Oversees and tracks clinical researchrelated payments. Payment reconciliation at study closeout. Oversees Anti Bribery and Denied Party Screenings, and maintenance of financial systems. Financial forecasting in conjunction with Sr.
COM /other roles.

  • Executes and oversees clinical trial country submissions and approvals for assigned protocols.
  • Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
  • Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
  • Contributes to the development of local SOPs.
  • Oversees Clinical Trial Coordinators as applicable.
  • Coordinates and liaises with Clinical Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
  • Collaborates closely with Headquarter to align country timelines for assigned protocols.
  • Provide support and oversight to local vendors as applicable.
  • Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
  • Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver countryspecific trial commitments and objectives especially during study startup.
  • Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
  • Works in partnership internally with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
  • Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
  • Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Qualifications, skills and education:

Core competencies:

  • Expertise of core clinical systems, tools and metrics
  • Excellent verbal and written influencing and training/mentoring skills, in local language and English
  • Strong coordination and organizational skills
  • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how this impact study startup.
  • Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal support from the Sr.
COM or manager.

  • Ability to make decisions independently with limited oversight from Sr.
COM or manager.

  • Requires strong understanding of local regulatory environment
  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
  • Ability to lead a team of Clinical Trial Coordinators as applicable

Behavioural Competency Expectations:

  • Problem solving is essential to this position. Requires the ability to proactively 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.
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