Clinical Operations Manager Finance (Término Fijo)
Clinical Operations Manager Finance (Término Fijo)
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Job Description
Job Description
This role is accountable for performance and compliance for assigned protocols in a country incompliance with ICH/GCP and country regulations Company policies and procedures qualitystandards and adverse event reporting requirements internally and externally.
Under the oversight of the Head COMs or CRD the person is responsible forbudget/finance aspects for execution and oversight of clinical trial country submissions andapprovals and to ensure Site Ready.
Responsibilities include but are not limited to:
Ownership of country and site budgets. Development negotiation and completion of ClinicalTrial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees FCPA DPS/OFAC and maintenance of financial systems. Financial forecasting inconjunction with /other roles.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Manages country deliverables timelines and results for assigned protocols to meet countrycommitments. Responsible for quality and compliance in assigned protocols in country.
Contributes to the development of local SOPs. Oversees CTCs as applicable.
Coordinates and liaises with CRM CTC CRA (Finance and Legal if appropriate) to ensurecountry deliverables are obtained for submissions budgets CTRAs and local closely with Headquarter to align country timelines for assigned protocols.
Enters and updatescountry information in clinical and finance systems.
Ownership of local financial compliance. The position has a significant impact onhow a country can deliver country-specific trial commitments and objectives especially duringstudy start-up.
Required to in/directly influence investigators external partners and country operations and
adheres to budget targets and agreed payment timelines.
Works in partnership internally with country operations finance regulatory affairs
pharmacovigilance legal and regional operations HQ functional areas and externally withvendors and sites IRB/IECs and Regulatory Authorities in submission and approval relatedi nteractions. Through continual interaction with local clinical team/s successfully delivers clinical
and financial contracts within fair market value.
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 asprocess Subject Matter Expert (SME) sharing best practices making recommendations forcontinuous improvement and providing training as appropriate/required.
Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required
Core competencies:
Expertise of core clinical systems tools and metrics
Excellent verbal and written influencing and training/mentoring skills in local language andEnglish
Strong coordination and organizational skills
Ability to indirectly influence investigators vendors external partners and country managers to
address and resolve issues with minimal support from the or manager.
Ability to make decisions independently with limited oversight from or manager.
Ability to proactively develop risk management and mitigation plans in the country and resolve
issues locally.
Ability to lead a team of CTCs as applicable
Behavioural Competency Expectations:
Problem solving is essential to this position.
Effective and efficient time management organizational and interpersonal skills conflictmanagement 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 andtraining/mentoring skills both written and verbal in local language and English.
Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires thatthe individual has ability to work effectively also in a remote virtual environment with a widerange of people.
Positive mindset growth mindset capable of working independently and being self-driven
Able to directly influence site staff
Experience Requirements:
Required:
5 years of experience in clinical research or combined experience in Clinical Research andFinance/Business
Educational Requirements:
Required:
Bachelors Degree in Business Finance/ Administration/ Life Science or equivalent Health Carerelated experience
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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:
Project Temps (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Clinical Research Clinical Site Management Clinical Testing Clinical Trial Agreements (CTA) Clinical Trial Compliance Clinical Trial Documentation Clinical Trial Management Clinical Trial Management Processes Clinical Trial Planning Clinical Trials Monitoring Clinical Trials Operations Cross-Cultural Awareness Customer Experience Management Economic Forecasting Financial Administration Financial Forecasting Global Sourcing ICH GCP Guidelines Management Process Negotiation Patient Recruitment Problem Solving Proven Commitment 3 morePreferred Skills:
Job Posting End Date:
09/6/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
