Senior Clinical trial and contract specialist m/f/d

1 week ago

Trenton, United States MSD Malaysia Full time

Senior Clinical trial and contract specialist m/f/d page is loaded

Senior Clinical trial and contract specialist m/f/d

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remote type

Not Applicable

locations

BEL - Brussels - Brussels (Souverain)

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R299593

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 processes to initiate, execute and close out early stage clinical trials clinical 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: Contracts Analyst activities: Review budgets in context (review budget vs protocol and agreement) and request documented approvals to allow timely regulatory submissions Prepare and execute Clinical Study Agreements based on approved templates Reconciliation of clinical study budgets Track clinical grant costs/payments versus contracts and payment milestones, execute payments Verify and generate grant payments/vouchers for investigator site and vendor payments Execute purchase orders and payment requests as required Run anti-bribery, denied persons screening checks and fact finding Obtain and follow-up Financial Disclosure as needed Generate and maintain/track disclosure agreements Set-up Master Service Agreements and maintain agreements and price lists, in close collaboration with site or vendor, manager, procurement, legal and other stakeholders as needed Use the company Grant Systems, SAP/COMET, ARIBA, eGPS Support vendor relationship tasks / assignments with preferred suppliers and sites, process purchase orders, check and track invoicing Request and track other payments as needed Update and maintain data for benchmarking of study and sourcing costs Develops in and maintains direct working relationships with:

HQ research procurement and global site agreements Site clinical and business staff, field monitoring staff Country financial, clinical and legal departments, procurement

Early Stage Clinical Trial Support activities : Assemble and provide support for timely Clinical Trial Submissions Update, maintain Essential Documents Repository (“Trial Master File”); Assemble and track availability of all essential documents required for study conduct Responsible for periodic in-house reconciliation of all essential documents in the electronic Trial Master File Update, maintain and monitor Clinical Trial Management System to allow accurate project management and regulatory reporting Follow-up on release, return and destruction of Investigational Medicinal Product Set-up of blood/urine samples shipments Follow-up on ancillary supplies shipments Review compliance of site staff vs non study specific training requirements Update operational trackers Organization and documentation (minutes) of project team meetings and presentations Education & Experience Work experience >3 yrs in clinical research is an asset Understanding and knowledge of study protocols and study working documents, lab manuals, clinical study data etc. High Interest in operational and financial aspects of clinical trials operations Bachelor or Master’s degree Very focused and detail and task oriented Excellent interpersonal skills and oral and written communication skills Data, spreadsheet, computer hardware/software proficiency, knowledge of excel Project and time management skills Good judgment, follow up and follow through Problem solving and decision making skills required Language skills Preferably Tri-lingual (English, Dutch, French) or at least English and one of the 2 languages Our offer : - Full training and support for employees - Career opportunities within the laboratory - Very attractive package with target bonus, vacation vouchers - Flexible working conditions Current Employees apply HERE Current Contingent Workers apply HERE 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: Regular

Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable

Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/31/2024

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Our company 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 we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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