Senior Clinical Trial Coordinator (Sr. CTC) - Remote

MSD•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. It helps meet planned Site Ready dates, including preparing submission packages for IRB/ERC and Health Authorities, and collaborates locally with COM, CRM, CRA, and finance/budgeting representatives to manage Clinical Trial Research Agreements (CTRAs) and payments. The role serves as a process Subject Matter Expert, recommending improvements, sharing best practices, providing training, and mentoring junior Clinical Trial Coordinators. It also supports regulatory and site start-up activities, financial and compliance procedures, meeting planning, and quality oversight.

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.
Excellent communication skills, including effective communication with external customers such as sites and investigators.
Good understanding of global and country/regional clinical research guidelines and ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Good IT skills, including Microsoft Office and clinical IT applications, and ability to adapt to new applications.
Strong Microsoft Excel skills.
ICH-GCP knowledge appropriate to the role.
Excellent negotiation skills for finance-related CTC work.
Strong time management, organizational, interpersonal, and conflict-management skills.
Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Ability to work effectively in a matrixed, multicultural environment and maintain culturally sensitive working relationships.
Commitment to internal and external customer focus.
Ability to work independently and take ownership of delegated tasks.
Proactive problem-solving attitude and ability to propose solutions.
Positive and growth mindset.

Nice To Haves

Clinical Trial Management Systems (CTMS) experience.
Clinical trials experience.
Leadership skills.

Responsibilities

Track essential documents and report items such as safety reports.
Collate and distribute study tools and documents.
Update clinical trial management systems (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, where applicable.
Prepare documents and correspondence; collate, distribute or ship, and archive clinical documents, including in the eTMF.
Assist with eTMF reconciliation and execute the eTMF Quality Control Plan.
Update manuals and documents, including patient diaries and instructions.
Document proper destruction of clinical supplies, prepare investigator trial file binders, and obtain document translations.
Provide and collect investigator forms and lists for site evaluation, validation, 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 where 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; and maintain contract templates with the Legal Department.
Calculate and execute payments to investigators, vendors, and grants.
Ensure adherence to financial and compliance procedures; monitor and track 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 managing invitations, preparing materials, selecting venues, and supporting vendors where applicable.
Act as a process Subject Matter Expert, contribute knowledge and best practices, recommend continuous improvements, and provide training as appropriate or required.
Mentor or buddy junior Clinical Trial Coordinators, including on process requirements.