Associate Clinical Operations Manager

Job DescriptionThis 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 Sr. COM, Head COMs or CRD, the person is responsible for Supporting
budget/finance aspects, for execution and oversight of clinical trial country submissionsandapprovals.
Responsibilities include, but are not limited to:

• Support to 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. Support of Financial
forecasting inconjunction with Sr.COM /other roles.

• Contribute to Execution and oversight clinical trial country submissions and approvals for assigned

protocols.

• Develops local language materials including local language Informed Consents and translations.
• Interact 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.
• 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.

• Provide support and oversight to local vendorsas applicable.
• 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 processmanagement. Enters and updatescountry information in clinical
and finance systems.

• Support of local regulatory and financial compliance. Ability to in/directly influence investigators,

external partners and countryoperations 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 clinicaland financial
contracts within fair market value.

• Contribute or lead initiatives and projectsadding value to the business, as appropriate/required.
• Contributes strongly to COM team and other Country Operations roles knowledge by acting

as/supporting 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 sharing best practices asappropriate/required.
• May act as buddy / mentor.

Qualification & Experience:

• 2-3 years of experience in Clinical Research or experience in Finance/Business

• Required: Associate Degree or equivalent Health Care related experience

• Preferred: Bachelor’s degree

Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements: Not ApplicableShift: Not IndicatedValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 05/24/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.