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Merck KGaA Darmstadt Germany - Springfield, IL
posted 2 months ago
About the position
The Clinical Trial Coordinator (CTC) plays a vital role in the Clinical Research and Pharmacovigilance team at Merck, focusing on the administration of clinical trials and site management. This position is responsible for preparing, collating, distributing, and archiving clinical documents, ensuring compliance with regulatory requirements, and supporting clinical supply management. The CTC collaborates closely with various stakeholders to ensure timely execution of trial activities and adherence to safety and efficacy standards for clinical products.
Responsibilities
- Track essential documents and report safety reports
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Manage clinical and non-clinical supply management in collaboration with other roles
- Coordinate labeling requirements and translation change requests
- Prepare and distribute clinical documents and correspondence
- Assist with eTMF reconciliation and execute eTMF Quality Control Plan
- Update manuals and documents such as patient diaries and instructions
- Document proper destruction of clinical supplies
- Prepare Investigator trial file binders
- Obtain translations of documents
- Provide and collect forms for site evaluation and submissions in a timely manner
- Track and update study insurance certificates
- Support preparation of submission packages for IRB/ERC and regulatory agencies
- Publish study results as required by local legislation
Requirements
- Fluent in local languages and business proficient in English (verbal and written)
- Good understanding of Global, Country/Regional Clinical Research Guidelines
- Hands-on knowledge of Good Documentation Practices
- Good IT skills, including MS Office and clinical IT applications, with strong MS Excel skills
- Knowledge of ICH-GCP appropriate to the role
- Excellent negotiation skills in finance area
- Effective time management, organizational, and interpersonal skills
- Ability to communicate effectively with external customers
- High sense of accountability and urgency
- Ability to set priorities and handle multiple tasks in a changing environment
- Ability to work effectively in a matrix multicultural environment
- Demonstrates commitment to customer focus
- Ability to work independently
- Proactive attitude to problem-solving and proposing solutions
- Positive and growth mindset
Nice-to-haves
- Bachelor's Degree preferred
Benefits
- Flexible work arrangements (remote)
