Clinical Trial Coordinator (CTC) – Regulatory (m/f/d)

MSD Malaysia • Rahway, NJ, United States • $200k - $250k / year • 2h ago

Clinical Trial Coordinator (CTC) – Regulatory (m/f/d)

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

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 Clinical Trial Coordinator (CTC) (m/f/d) 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 the local level closely with COM, CRM, and CRA. The person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities include, but are not limited to:

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
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, Word, OneNote skills required.
ICH-GCP Knowledge appropriate to role
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
Minimum 1 year experience in role or relevant Clinical Research experience

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact on our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

#J-18808-Ljbffr