Merck Clinical Operations Manager (Finance) - REMOTE in Rahway, New Jersey
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the Sr COM (Clinical Operations Manager) ,COM-F Manager or CRD (Clinical Research Director), the person is responsible for budget/finance aspects.
Responsibilities include, but are not limited to:
• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs. Oversees CTCs (Clinical Trial Coordinators) as applicable.
• Coordinates and liaises with CRM (Clinical Research Manager), CTC (Clinical Trial Coordinator), CRA (Clinical Research Associate), (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.
• 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 to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
• Works in partnership internally with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
• Expertise of core clinical systems, tools and metrics
• Excellent English skills
• Strong coordination and organizational skills
• Skilled knowledge of 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 SCOM 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.
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 management as applicable. Specific examples of common problems include: 1) issues in budget/CTRA negotiations 2)Quality and compliance issues, 3) legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
• 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.
Education Minimum Requirement:
• Bachelor's Degree
Required Experience and Skills**: 3 years of experience in clinical research, 2 year minimum in negotiation contracts and/or budgets.
Preferred Experience and Skills:
• Juris Doctor; Master's Degree (or comparable)
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job Clinical Research Monitor
Other Locations: NA-United States
Title: Clinical Operations Manager (Finance) - REMOTE
Primary Location: NA-US-NJ-Rahway
Requisition ID: CLI008636
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