MSD Clinical Operations Manager 

Italy, Lazio 

496105920

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.

This role is accountable for performance and compliance for assigned protocols in a country, in compliance with ICH/GCP and country regulations, company’s 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, with particular focus on legal aspects of clinical trials and related activities.

Responsibilities include but will not be limited to the following key activities:

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Consolidated experience in Contract Negotiation and managing relationship with Hospital Administrations.

• Extensive experience in financial aspects of clinical project management, included legal procedures. Background in business finance and strong knowledge in accounting and financial procedures.

• Coordinates and liaises with CRM, CTC, CRA, Finance and Legal department 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.

• Oversee and ownership of local financial processes and compliance. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

• Contributes strongly to Finance 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 asappropriate/required.

• 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.

• Provide support and oversight to local vendors as applicable.

• Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.

• Contribute or lead initiatives and projects adding value to the business, asappropriate/required.

• Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Your profile

• Bachelor's Degree in Legal/Business Finance

• At least 5 years clinical research experience

• Extensive experience in financial aspects of clinical project management

• 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 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

Current Contingent Workers apply