Clinical Trial Coordinator (CTC)

Merck Gruppe - MSD Sharp & Dohme; Lima Metropolitana; Hybrid; PEN 54,000 - 78,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck Sharp & Dohme in Lima, Peru is seeking a Clinical Trial Coordinator to manage site administration, document control, and trial tracking tools. You will support IRB/Health Authority submissions and collaborate with local teams.

The role emphasizes budgeting, contract management, eTMF activities, and regulatory support, requiring English proficiency and strong organizational skills. Hybrid work arrangement applies.

Qualifications

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

Responsibilities

• Develop, 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 essential documents and report (Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update CTMS databases and trackers
• Clinical supply & non-clinical supply management
• Manage labeling requirements and coordinate translation change requests
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents (eTMF)
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Document proper destruction of clinical supplies
• Prepare Investigator trial file binders
• Obtain translations of documents
• Provide submission support for IRB/ERC and regulatory agencies
• Publish study results where required per local legislation

Skills

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

Contract processing

Customer centricity

Data analysis

Decision making

Documentation preparation

Document management

Drug regulatory affairs

Growth mindset

ICH GCP guidelines

Education

Bachelor’s Degree

Job description

Location: Lima, Lima, Peru

Job Type: Full time

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:

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

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)
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities

• 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

• 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
• 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.
• 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

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.

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

Requisition ID: R421334