MSD Clinical Operations Manager Lead 

Italy, Lazio 

407235500

Job Description

Responsibilities include, but are not limited to:

• Having significant impact on how a country can deliver country-specific trial commitments and objectives, especially during study start-up;
• Taking ownership of country and site budgets. Taking care of development, negotiation, and completion of Clinical Trial Research Agreements (CTRA);
• Interacting successfully with local clinical team/s 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;
• Executing and oversighting of clinical trial country submissions and approvals for assigned protocols, development of local language materials, including local language Informed Consents and translations;
• Working in partnership with IRB/IEC and Regulatory Authority, in submission and approval-related interactions for assigned protocols;
• Managing country deliverables, timelines and results in assigned protocols to meet country commitments. Being responsible for quality and compliance in assigned protocols in the country. Contributing to the development of local/Int'l SOPs;
• Overseeing contract workers (e.g. COMs and CTCs) and local vendors;
• Managing direct reports, including performance plans and development plans. Effectively managing performance issues;
• Working with minimal oversight from CRD or line manager, in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas, and externally with vendors, sites and other stakeholders, in order to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones;
• Mantaining close collaboration with Regional Operations and/or Headquarters, to align country timelines for assigned protocols;
• Providing 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.
• Entering and updating country information in clinical, regulatory, safety and finance systems;
• Contributing or leading initiatives and projects, adding value to the business, as appropriate/required.

Education and Minimum 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;
• 8 years of experience in clinical research;
• 2 years of people management or oversight experience.

Required experience and Skills:

• 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, submission and approval processes;
• Strong coordination and organizational skills;
• Background in business finance is preferred, along with strong knowledge and aptitude in accounting and financial procedures;
• People Management skills, also across countries;
• Demonstrated proactive leadership and ability 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;
• 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: Issues in budget / CTRA negotiations, Quality and compliance issues, Regulatory and legal issues, and issues related to functional area deliverables that could jeopardize protocol milestones. Problem solving and Process Improvement is essential to this position;
• Fluency in both English and local language.

Behavioral Competency Expectations:

• Strong communication and leadership skills.
• Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.
• 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.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.