MSD Senior Clinical Trial Coordinator 

Poland, Masovian Voivodeship 

793745868

Job Description

This role is responsible for comprehensive trial and site administration. Under the oversight of the COM Lead the person prepares, collates, distributes and archives 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 Authorities. The role will collaborate at local level closely with COM, CRM and CRA and the person collaborates with finance/budgeting representatives to manage 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 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 of Clinical supply & non-clinical supply management, in collaboration with other country roles

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 o Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

• Support preparation of submission package for Authorities

Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:

• Ensure adherence to financial and compliance procedures o

• Monitor and track adherence and disclosures,

• Maintain tracking tools

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 junior CTCs (including, but not limited to process requirements)

CORE Competency Expectations:

• 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

Behavioural Competency Expectations:

• 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

Experience Requirements:

• Minimum 3 - 5 years in Clinical Research or relevant healthcare experience

• sCTC in Regulatory area: Minimum 2 years in Regulatory area (submissions to Authorities)

Educational Requirements:

• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:08/02/2024

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.