MSD Clinical Operations Manager 

Romania, Bucharest 

366300014

Job Description

The Clinical Trials Operations Manager (CTOM) will play a critical role in overseeing the execution of clinical trials in alignment with ICH/GCP guidelines and local regulations. This position is responsible for managing budgets, regulatory submissions, and ensuring that all trials are set up for success. Under the guidance of the Clinical Operations Manager Lead (COM Lead), the CTOM will ensure all trials meet quality and compliance standards while delivering on time and within budget.

Key Responsibilities:

• Budget Management: Take ownership of country and site budgets, including the development, negotiation, and finalization of Clinical Trial Research Agreements (CTRA).
• Regulatory Submissions: Execute and oversee clinical trial country submissions and approvals for assigned protocols.
• Local Language Materials: Develop and manage local language materials such as Informed Consent Forms and translations, ensuring compliance with local regulations.
• Stakeholder Interaction: Work closely with Institutional Review Boards (IRB), Ethics Committees (IEC), and Regulatory Authorities to facilitate timely approvals.
• Project Coordination: Manage country deliverables, timelines, and results for assigned protocols to ensure alignment with country commitments and international standards.
• Cross-Functional Collaboration: Coordinate with Clinical Research Managers (CRM), Clinical Trial Coordinators (CTC), and Clinical Research Associates (CRA) to ensure successful navigation of submissions, budgets, and milestones.
• Regulatory and Financial Compliance: Ensure adherence to local regulatory standards and financial practices. Proactively manage risks and develop mitigation plans as necessary.
• Mentorship and Training: Act as a Subject Matter Expert (SME) within the Clinical Operations Management (COM) team, facilitating knowledge sharing and best practices.

Core Competencies:

• In-depth knowledge of clinical systems, tools, and metrics.
• Excellent verbal and written communication skills in both local language and English.
• Strong organizational skills with a proven ability in budget and contract negotiations.
• Comprehensive understanding of the local regulatory environment and its effects on study start-up.
• Capable of independently making decisions and resolving issues with minimal oversight.

Behavioral Competencies:

• Strong problem-solving aptitude with the ability to proactively identify and address issues related to compliance, budget negotiations, and regulatory challenges.
• Exceptional time management and organizational skills to prioritize multiple deliverables effectively.
• High level of accountability and urgency, with great interpersonal and conflict management skills.
• Positive, growth-oriented mindset with independent, self-driven work capability.

Experience Requirements:

• Minimum 5 years of experience in clinical research or a combination of clinical research and finance/business.
• Bachelor's Degree in Business Finance, Administration, Life Science, or an equivalent healthcare-related field.

Current Contingent Workers apply

Not Indicated

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