Clinical Operations Manager Regulatory - Supply (Fixed Term)
Clinical Operations Manager Regulatory - Supply (Fixed Term)
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Job Description
Job Description
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations Company policies and procedures quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the Head COMs or CRD the person is responsible for
budget/finance aspects for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
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 closeout. Oversees FCPA DPS/OFAC and maintenance of financial systems. Financial forecasting in conjunction with /other roles.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents and
translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
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 as applicable.
Coordinates and liaises with CRM CTC CRA (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.
Provide 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 and adheres to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations finance regulatory affairs pharmacovigilance legal and regional operations HQ functional areas and externally with vendors and sites IRB/IECs and Regulatory Authorities in submission and approval related interactions. 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 as process Subject Matter Expert (SME) sharing best practices making recommendations for continuous 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 and English
Strong coordination and organizational skills
Skilled knowledge of budget and contract negotiations local 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 or manager.
Ability to make decisions independently with limited oversight from 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.
Ability to lead a team of CTCs as applicable
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) Regulatory and legal issues and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
Effective and efficient time management organizational and interpersonal skills conflict management 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 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.
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 and Finance/Business
Educational Requirements:
Required:
Bachelors Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related 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:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability Adaptability Applied Engineering 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 Economic Forecasting Financial Administration Financial Forecasting Global Sourcing ICH GCP Guidelines Management Process Patient Recruitment Pharmacovigilance Problem Solving Regulatory Compliance 3 morePreferred Skills:
Job Posting End Date:
08/29/2025*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
