Clinical Trial Coordinator (CTC)

MSD

Greater London

On-site

GBP 36,000 - 48,000

Full time

9 days ago
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Benefits offered by this job

Hybrid work arrangement

Job summary

MSD Malaysia is seeking a detail-oriented professional to oversee trial and site administration, document control, and regulatory submission support. You will coordinate study tools, maintain CTMS trackers, and ensure compliant handling of CTRAs and payments while partnering with finance, COM, CRM and CRA teams.

This hybrid role requires strong IT skills, GCP knowledge, and the ability to manage multiple tasks in a global clinical environment.

Qualifications

  • Completed job training in office management, administration, finance or health care, or a Bachelor’s degree.
  • Audit trails and budget development experience preferred.
  • Knowledge of GCP/ICH guidelines is advantageous.

Responsibilities

  • Track essential documents and report safety-related data.
  • Collate, distribute and archive clinical documents (eTMF).
  • Update CTMS trackers and manage study tools.
  • Support regulatory submissions and start-up activities.
  • Process contracts, CTRAs and payments with finance.
  • Organize meetings and support investigator sessions.

Skills

Local language fluency
English proficiency
Communication skills
Good Documentation Practices
MS Excel skills
ICH-GCP knowledge

Education

Bachelor’s Degree

Tools

MS Office
Clinical IT applications

Job description

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 solutionsPositive 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 Preferred Skills:

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.
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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