Clinical Trial Coordinator (CTC)

Remote Worker LTD.; Greater London; Hybride; GBP 42 000 - 65 000; Plein temps

Résumé du poste

Merck & Co., Inc. in Rahway, NJ, USA seeks a Clinical Trial/Site Administration professional to manage essential documents, CTMS updates, and supply coordination across country roles. The role supports IRB/ERC submissions and regulatory filings while ensuring timely site readiness.

You will collaborate with COM/CRM/CRA and finance teams to manage CTRAs, budgets and payments. Hybrid work arrangements are offered.

Qualifications

• Audit trails and documentation practices established in clinical trials.
• Familiarity with regulatory and financial procedures for trials.
• Understanding of GCP and international guidelines.

Responsabilités

• Track essential documents and report safety information.
• Collate, distribute and archive study tools and documents.
• Update CTMS and trackers used in trials.
• Coordinate clinical and non-clinical supply management with country teams.
• Manage labeling and translation change requests with other country roles.
• Prepare and archive clinical documents (eTMF and related materials).
• Assist with eTMF reconciliation and quality control.
• Publish study results for appropriate authorities.
• Develop and maintain country/site budgets; negotiate contracts.
• Monitor contract negotiations and payments; maintain templates.
• Organize meetings and support investigator meetings.
• Obtain and track study insurance certificates.
• Support regulatory submissions (IRB/ERC and authorities).
• Ensure compliance with financial procedures and disclosures.
• Organize submission materials and ensure timely start-up activities.
• Maintain tracking tools and perform required documentation updates.

Connaissances

Audit Trails

Budget Development

Clinical Data Management

Clinical Research

Clinical Trial Compliance

Clinical Trial Management

Clinical Trials Monitoring

Clinical Trials Operations

Clinical Trial Support

GCP

ICH GCP Guidelines

Formation

Bachelor’s Degree

Description du poste

Job Description

Brief Description:

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role 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:

• Trial and site administration:
  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
• 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.
  • Prepare Investigator trial file binders
  • Obtain translations of documents
• Regulatory & 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
  • Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation
• 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
• Meeting Planning:
  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Skills:

• 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
• 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

Qualification & Experience:

• Completed job training (office management, administration, finance, health care preferred) or
• Bachelor’s Degree

Required Skills:

Audit Trails, Budget Development, Clinical Data Management, Clinical Research, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Good Clinical Practice (GCP), ICH GCP Guidelines

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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/14/2026

*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.