• Job Description

  Req#: R299898

  Job Description

  This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, comprany 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 full logistics aspects for clinical and non-clinical supplies during the entire duration of clinical trial.

  Responsibilities include but are not limited to:

  • Contribute to Execution and oversight clinical trial country submissions and approvals 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.
  • Provide support and oversight to local vendors as 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 process management. Enters and updates country information in clinical and finance systems.
  • 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.
  • 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/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 as appropriate/required.
  • May act as buddy / mentor.

  Requirements:

  • 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

  Join our team and be a part of making a difference in patients' lives through groundbreaking clinical research. Apply now and take your career to new heights.

  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:

  No relocation

  VISA Sponsorship:

  No

  Travel Requirements:

  25%

  Flexible Work Arrangements:

  Hybrid

  Shift:

  Not Indicated

  Valid Driving License:

  No

  Hazardous Material(s):

  N/A

  Job Posting End Date:

  08/6/2024

  *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.

• About the company

  Merck & Co., Inc.

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