Senior Clinical Trial Coordinator (Sr. CTC) - Remote

Merck • Rahway, NJ

3d • $74,000 - $117,900 • Remote

About The Position

Under the oversight of the line manager, the Senior Clinical Trial Coordinator is responsible for comprehensive trial and site administration, including preparing, collating, distributing, and archiving clinical documents. The role supports clinical and non-clinical supply management and maintains tracking and reporting tools to help meet planned site-ready dates, including preparation of IRB/ERC and Health Authority submission packages. The coordinator works locally with COM, CRM, and CRA colleagues and with finance and budgeting representatives on clinical trial agreements and payments.

The role serves as a process subject matter expert, recommends process improvements, provides training, and mentors junior CTCs. Responsibilities span trial and site administration, document management, regulatory and site start-up activities, budgeting and agreements, meeting planning, and quality oversight. This is a remote role with 10% travel. The stated salary range is $74,000–$117,900, and the successful candidate is eligible for an annual bonus and long-term incentive, if applicable.

Requirements

• At least 3 years of experience in Clinical Research or relevant healthcare experience.
• Completed job training, preferably in office management, administration, finance, or healthcare, or a Bachelor's degree.
• Fluency in local languages and business proficiency in English, both verbal and written.
• Good understanding of global and country/regional clinical research guidelines and ability to work within them.
• Hands-on knowledge of Good Documentation Practices and ICH-GCP knowledge appropriate to the role.
• Good IT skills, including Microsoft Office and clinical IT applications, and ability to adapt to new IT applications; strong Microsoft Excel skills required.
• Excellent negotiation skills for CTC finance activities.
• Excellent communication skills, including effective communication with external customers such as sites and investigators.
• Strong time management, organizational, interpersonal, and conflict-management skills.
• High accountability and urgency; ability to prioritize and handle multiple tasks in a changing environment.
• Ability to work effectively in a multicultural matrix environment and establish culturally sensitive working relationships.
• Commitment to internal and external customer focus.
• Ability to work independently and take ownership of delegated tasks; proactive problem-solving and solution-proposing attitude.
• Positive and growth mindset; willingness to share best practices and contribute to team knowledge.

Nice To Haves

• Clinical Trial Management Systems (CTMS) experience.
• Clinical Trials experience.
• Leadership experience.

Responsibilities

• Track and report trial and site materials, including essential documents and safety reports.
• Collate and distribute study tools and documents; update clinical trial databases, including CTMS, and trackers.
• Manage clinical and non-clinical supplies in collaboration with other country roles; manage labeling requirements and coordinate or sign translation change requests when applicable.
• Prepare documents and correspondence; collate, distribute or ship, and archive clinical documents, including in eTMF systems.
• Assist with eTMF reconciliation, execute the eTMF Quality Control Plan, update manuals and documents, document destruction of clinical supplies, prepare Investigator Trial File binders, and obtain document translations.
• Provide and collect investigator forms and lists for site evaluation or validation, site start-up, and submissions; obtain, track, and update study insurance certificates.
• Support preparation of IRB/ERC submission packages and submissions to regulatory agencies; publish study results for GCTO and RA when required by local legislation.
• Collaborate with finance and budgeting representatives to develop, control, update, and close out country and site budgets, including split site budgets.
• Develop, negotiate, approve, and maintain contracts such as CTRAs; track and report contract negotiations; update contract templates with the Legal Department.
• Calculate and execute payments to investigators, vendors, and grants; ensure compliance with financial and compliance procedures; monitor adherence and disclosures; maintain tracking tools; and obtain and process FCPA documentation promptly.
• Organize meetings and create and track study memos, letters, and protocols; support local investigator meetings by handling invitations and materials, selecting venues, and supporting vendors where applicable.
• Act as a process subject matter expert, share best practices, recommend continuous improvements, and provide training as appropriate or required.
• Mentor and buddy junior CTCs, including on process requirements.

Benefits

• Annual bonus eligibility.
• Long-term incentive eligibility, if applicable.
• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior