Senior Clinical Trial Coordinator (Sr. CTC) - Remote

1000 Merck Sharp & Dohme LLC; Rahway (NJ); Remote; USD 74,000 - 118,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan

Paid holidays and vacation

Sick days

Job summary

MSD in Rahway, NJ seeks an experienced Clinical Trial Coordinator to oversee trial and site administration, ensure proper documentation, and support regulatory submissions. You will collaborate with COM/CRM/CRA and finance to manage CTRAs, payments, and budgets, driving process improvements and mentoring junior staff.

The role requires 3+ years in clinical research or healthcare, plus a Bachelor's degree and strong MS Excel skills.

Qualifications

• Minimum 3 years in Clinical Research or healthcare experience.
• Bachelor’s Degree or higher with related training.
• Experience with CTMS and regulatory documentation.

Responsibilities

• Track essential documents and report safety reports; collate and archive study tools.
• Update CTMS and trackers; manage clinical and non-clinical supply in collaboration with country roles.
• Coordinate labeling changes and obtain site-start up and regulatory submissions.
• Assist with eTMF reconciliation and Quality Control Plan; maintain manuals and documents.
• Support budgeting, CTRAs, and payments; ensure financial/compliance procedures.

Skills

Clinical Research

Clinical Trial Compliance

Clinical Trial Management

Customer-Focused

GCDMP

Time Management

Training Delivery

Leadership

Education

Bachelor’s Degree

Tools

Microsoft Excel

Microsoft Office

CTMS

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. The person acts as process Subject Matter Expert (SME), making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior CTCs.

Responsibilities

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: 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). Quality & Oversight: Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Mentors / buddies to junior CTCs (including, but not limited to process requirements).

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. Highly 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 taking full ownership of delegated tasks. Proactive attitude to solving problems / proposing solutions. Positive mindset, growth mindset. Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Qualifications & Experience

Minimum 3 years in Clinical Research or relevant healthcare experience. Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree. #MSJR #eligibleforERP #clinicaltrialjobs

Salary

The salary range for this role is: $74,000 - $117,900 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Benefits

• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Required Skills

Clinical Research, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Customer-Focused, Good Clinical Data Management Practice (GCDMP), Microsoft Excel, Microsoft Office, Time Management, Training Delivery

Preferred Skills

Clinical Trial Management Systems (CTMS), Clinical Trials, Leadership

Equal Employment Opportunity

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Search Firm Policy

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.

Other Information

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a

Job Posting End Date: 11/10/2026 *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.