Clinical Operations Manager Lead (Finance)

Job Description

This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company policies and procedures and with quality standards, both internally and externally.

The person has ownership, oversight, and impact on local financial compliance and on regulatory or out-tasking, as applicable. Under the oversight of the CRD, or Head of Country Operations, the person is responsible for managing/overseeing a team of COMs and/or CTCs.

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; development, negotiation, and completion of Clinical Trial Research Agreements (CTRA); oversight of legal aspects as applicable
• Successfully interacting with local clinical team/s, in order to deliver clinical and financial contracts within fair market value;
• Interacting and collaborating with our local legal office and our local finance office, as applicable;
• Taking ownership of all clinical research-related payments, and oversight of all associated activities conducted within GCTO Italy. 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;
• Being responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Being responsible for quality and compliance in assigned protocols within 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, to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones;
• Collaborating closely 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;
• Being responsible for the execution and oversight of clinical trial country submissions and approvals for assigned protocols, and the 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;         
• Minimal travel required.

Qualifications

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 and submission and approval processes;
• Strong coordination and organizational skills; ability to focus on multiple deliverables and protocols simultaneously is essential.
• Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures;
• Demonstrates leadership behaviors and People Management skills, also across countries;
• Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country