• Job Description

  Req#: R305403

  Job Description

  The role is critical to meet planned Site Ready dates, and will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

  Responsibilities include, but are not limited to:

  o Trial and site administration:

  • Track (e.g. essential documents) and report

  • Ensure collation and distribution of study tools and documents

  • Update clinical trial databases (CTMS) and trackers

  o Document management:

  • Prepare documents and correspondence

  • Collate, distribute/ship, and archive clinical documents, e.g. eTMF

  • Assist with eTMF reconciliation

  • Execute eTMF Quality Control Plan

  • Update manuals/documents (e.g., patient diaries, instructions)

  • Document proper destruction of clinical supplies.

  o Site Start-Up responsibilities: Collaborate with other country roles to:

  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

  • Obtain, track and update study insurance certificates

  o Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:

  • Develop, control, update and close-out country and site budgets (including Split site budget)

  • Develop, negotiate, approve and maintain contracts (e.g. CTRAs)

  • Track and report contract negotiations

  • Update and maintain contract templates (in cooperation with Legal Department)

  • Calculate and execute payments (to investigators, vendors, grants)

  • Ensure adherence to financial and compliance procedures

  • Monitor and track adherence and disclosures

  • Maintain tracking tools

  • Obtain and process FCPA documentation in a timely manner

  Current Employees apply HERE

  Current Contingent Workers apply HERE

  Secondary Language(s) Job Description:

  CORE Competency Expectations:

  • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills

  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

  • Hands on knowledge of Good Documentation Practices

  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.

  • ICH-GCP Knowledge appropriate to role

  • Excellent negotiation skills for CTCs in finance area

  Behavioral Competency Expectations:

  • Effective time management, organizational and interpersonal skills, conflict management

  • Effective communication with external customers (e.g. sites and investigators)

  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

  • Demonstrates commitment to Customer focus, both internally and externally.

  • Able to work independently

  • Proactive attitude to solving problems / proposing solutions

  • Positive mindset, growth mindset, capable of working independently with assigned tasks

  • Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

  Experience Requirements:

  • Minimum 1 - 2 years in Clinical Research or relevant healthcare experience

  Educational Requirements:

  • Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.

  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:

  Hybrid

  Shift:

  Valid Driving License:

  Hazardous Material(s):

  Job Posting End Date:

  08/2/2024

  *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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