Clinical Operations Manager

Job Description

We are seeking a highly motivated and experienced Clinical Operations Manager to join our team. We are a leading healthcare organization dedicated to providing exceptional clinical care and improving patient outcomes.

As a Clinical Operations Manager, you will play a pivotal role in maintaining the smooth and efficient operation of our clinical services. You will be responsible for managing and coordinating the daily activities of the operational of our clinical trials, ensuring compliance with regulatory standards, and implementing the logistic and best practices to enhance patient care.

Responsibilities:

Budget and Financial Management:

• Take ownership of country and site budgets, including the development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).
• Oversee and track clinical research-related payments and reconcile payments at study closeout.
• Ensure compliance with financial regulations (FCPA, DPS/OFAC) and maintain financial systems.
• Collaborate with Senior Clinical Operations Manager (Sr. COM) and other roles for financial forecasting.

Clinical Trial Submissions and Approvals:

• Execute and oversee clinical trial country submissions and approvals for assigned protocols.
• Develop local language materials, including informed consents and translations.
• Interact with Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) and Regulatory Authorities for protocol-related matters.

Country Deliverables and Timelines:

• Manage country deliverables, timelines, and results for assigned protocols, ensuring compliance and quality.
• Contribute to the development of local Standard Operating Procedures (SOPs) and oversee Clinical Trial Coordinators (CTCs) as applicable.
• Coordinate with various stakeholders to obtain country-specific submissions, budgets, and milestones.

Vendor and Process Management:

• Provide support and oversight to local vendors, ensuring compliance with requirements.
• Coordinate local processes, including supplies management, importing/exporting, filing, archiving, and insurance management.
• Maintain accurate country information in clinical and finance systems.

Regulatory and Financial Compliance:

• Ensure local regulatory and financial compliance, having a significant impact on trial commitments and objectives during study start-up.
• Influence investigators, external partners, and country operations to adhere to budget targets and payment timelines.

Collaboration and Knowledge Sharing:

• Collaborate internally with various departments such as finance, regulatory affairs, and legal.
• Establish strong partnerships externally with vendors, sites, IRB/IECs, and Regulatory Authorities for submission and approval-related interactions.
• Contribute to initiatives and projects that add value to the business.
• Share best practices, provide training, and act as a mentor within the COM team and other Country Operations roles.

Qualifications:

• Bachelor's degree in healthcare administration, nursing, or a related field (Master's degree preferred).
• Minimum of 5 years of experience in Clinical Operations management and 2 years of experience in Regulatory / Finance in Clinical Research.
• Strong knowledge of healthcare regulations, compliance standards, and best practices.
• English: professional knowledge.
• Excellent leadership, communication, and interpersonal skills.
• Proven ability to lead and motivate a diverse team.
• Strong analytical and problem-solving abilities.
• Proficiency in using healthcare management software and electronic medical records systems.

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Current Contingent Workers apply HERE

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R280007