Job Description

Job Description

As part of a dynamic and passionate team, this specialist is responsible for hybrid operational support in phase 1 early stage clinical trials across Europe.  .  

This hybrid operational function includes, but is not limited to:

operational project support to the Early Stage Development Scientist, responsibility for in-house operational activities in compliance with internal processes to initiate, execute and close out early stage clinical trialsclinical trial agreements and study or study related budgets (planning, negotiation and maintenance), clinical grants payments and procurement activities to support clinical study programs

Essential tasks include, but are not limited to:

ESDS assistant activities:

Assemble and provide support for timely Clinical Trial SubmissionsUpdate, maintain Essential Documents Repository (“Trial Master File”); Assemble and track availability of all essential documents required for study conductResponsible for periodic in-house reconciliation of all essential documents in the electronic Trial Master FileUpdate, maintain and monitor Clinical Trial Management System to allow accurate project management and regulatory reportingFollow-up on release, return and destruction of Investigational Medicinal ProductSet-up of blood/urine samples shipmentsFollow-up on ancillary supplies shipmentsReview compliance of site staff vs non study specific training requirementsUpdate operational trackersOrganization and documentation (minutes) of project team meetings and presentationsPossibility for SME roles on operational tasks/systemsmaintenance of ESDS Asst activity aids

Contracts Analyst activities:

Review budgets in context (review budget vs protocol and agreement) and request documented approvals to allow timely regulatory submissionsPrepare and execute Clinical Study Agreements based on approved templatesReconciliation of clinical study budgetsTrack clinical grant costs/payments versus contracts and payment milestones, execute paymentsVerify and generate grant payments/vouchers for investigator site and vendor paymentsExecute purchase orders and payment requests as requiredRun anti-bribery, denied persons screening checks and fact findingObtain and follow-up Financial Disclosure as neededGenerate and maintain/track disclosure agreementsAssist in the review of Master Service Agreements and maintain agreements and price lists, in close collaboration with site or vendor, sr contracts analyst, manager, procurement, legal and other stakeholders as neededUse the company Grant Systems, SAP/COMET, ARIBASupport vendor relationship tasks / assignments with preferred suppliers and sites, process purchase orders, check and track invoicingRequest and track other payments as neededUpdate and maintain data for benchmarking of study and sourcing costsDevelops in and maintains direct working relationships with:HQ research procurement and global site agreementsSite clinical and business staff, field monitoring staffcountry financial, clinical and legal departments, procurementESDS

Education & Experience

Work experience for a few years in clinical research is an assetUnderstanding and knowledge of study protocols and study working documents, lab manuals, clinical study data etc.Interest in operational and financial aspects of clinical trials operationsBachelor or Master’s degreeVery focused and detail and task orientedExcellent interpersonal skills and oral and written communication skillsData, spreadsheet, computer hardware/software proficiency, knowledge of excelProject and time management skillsGood judgment, follow up and follow throughProblem solving and decision making skills required

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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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Anti-Bribery Policy, Anti-Bribery Policy, Benchmarking Studies, Business, Clinical Data Management, Clinical Investigations, Clinical Site Management, Clinical Study Design, Clinical Testing, Clinical Trial Management, Clinical Trials Logistics, Clinical Trials Monitoring, Clinical Trial Support, Contract Management, Drug Development, Ethical Standards, ICH GCP Guidelines, Management Process, New Technology Integration, Patient Recruitment, Patient Safety, Procurement, Project Management, Protocol Development, Purchase Orders {+ 1 more}

 Preferred Skills:

Job Posting End Date:

08/31/2025

*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.

Requisition ID:R355152