Job Description

About Us: We are passionate about driving innovation in clinical research. Our mission is to enhance the quality of health outcomes through rigorous research, collaboration, and commitment to excellence. We are looking for a skilled Clinical Trials Operations Manager to join our team and lead our efforts in ensuring compliance and performance for clinical trials.

Position Overview: 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.

Why Join Us? Joining our company means being part of a reputable organization dedicated to research excellence and patient care. We provide a collaborative work environment where innovation thrives, and your contributions positively impact the future of healthcare. If you are ready to take on a challenging and rewarding role, we would love to hear from you!

We are committed to creating an inclusive environment for all employees. We welcome applications from diverse backgrounds and experiences.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/15/2025

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