Clinical Operations Manager at MSD

Job Description

• Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Brief Description of Position:

• This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Under the oversight of the Sr. COM, Head COMs or CRD, 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 research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, 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 CTCs as applicable.
•  Coordinates and liaises with CRM, CTC, CRA, (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 country-specific trial commitments and objectives especially during study start-up.
•  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 GCTO 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 Experience:

Core competencies:

•  Expertise of core clinical systems, tools and metrics
•  Excellent verbal and written influrencing 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 these impact study start-up.
•  Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal 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 CTCs as applicable

Behavioral Competency Expectations:

•  Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze 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.
•  Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
•  High sense of accountability and urgency in order to properly prioritize deliverables
•  Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
•  Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
•  Positive mindset, growth mindset, capable of working independently and being self-driven
•  Able to directly influence site staff

Experience Requirements:

•  5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Educational Requirements:

•  Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience