Clinical Operations Manager

5 giorni fa

Roma, Italia Merck Gruppe - MSD Sharp & Dohme A tempo pieno

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, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the COM Lead, the person is responsible for budget/finance aspects, execution and oversight of clinical trial country submissions and approvals, and ensuring Site Ready.
Responsibilities include, but are not limited to:
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;
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;
Provides 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;
Contributes or leads 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;
Acts as buddy/mentor and shares best practices as appropriate/required.
Education and Minimum Requirements:
Bachelor’s or advanced degree in science and/or relevant work experience in direct site management (monitoring) in bio/pharma/CRO.
Required Experience and Skills:
Bachelor's Degree in Business Finance/ Administration/ Life Science;
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 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.

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