MSD Clinical Operations Manager 

Romania, Bucharest 

385078609

Job Description

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, 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, 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).
• 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.
• 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.
• 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 & Experience:

• 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 COM Lead.
• Ability to make decisions independently with limited oversight from COM Lead.
• Requires strong understanding of local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
• 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 managements 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

Current Contingent Workers apply

Not Indicated

*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.

Job Posting End Date:08/04/2024

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.