Clinical Trial Coordinator (CTC)

MSD LATAM; Lima Metropolitana; Hybrid; PEN 179,000 - 262,000; Full time

Job summary

Merck & Co., Inc. in Lima, Peru, seeks a Clinical Trial Coordinator to manage trial administration, budgeting, and contract processes while collaborating with local teams and regulatory bodies.

The role supports site readiness, prepares submission packages for IRB/ERC and health authorities, and maintains trial documents and trackers within a hybrid work setting.

Qualifications

• Bachelor’s Degree or equivalent in a related field.
• Strong knowledge of clinical trial documentation practices and GCP.
• Experience with CTMS, eTMF and regulatory submissions is desirable.

Responsibilities

• Budgeting, Agreement and Payments.
• Develop, control, update and close-out country and site budgets.
• 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.
• Track and report safety/essential documents and study tools.
• Update clinical trial databases (CTMS) and trackers.
• Clinical supply and non-clinical supply management in collaboration with country roles.
• Prepare Investigator trial file binders and archiving.

Skills

Accountability

Analytical Problem Solving

Audit Trails

Budget Development

Clinical Data Management

Clinical IT

Clinical Research

Clinical Trial Compliance

Documentation Preparation

ICH-GCP Guidelines

Contract Processing

Regulatory Knowledge

Cross-functional Collaboration

Education

Bachelor’s Degree

Office Management/Administration background

Job description

Job 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

Principal

• Budgeting, Agreement and Payments

Collaborate with finance/budgeting representatives for

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

• 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

Desirable

• 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

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

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

Accountability, Accountability, Analytical Problem Solving, Audit Trails, Budget Development, Clinical Data Management, Clinical IT, Clinical Research, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Compliance Reporting, Conflict Management, Contract Processing, Customer Centricity, Data Analysis, Decision Making, Documentation Preparation, Document Management, Drug Regulatory Affairs, Growth Mindset, ICH GCP Guidelines {+ 9 more}

Employee Status

Regular

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

10/26/2026

• 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.

Requisition ID

R421334

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.