Associate Clinical Supply Services

6 months ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

**Clinical Trial Supply Associate**

Clinical Trial Supply is a global team of Clinical trial Supply Managers and Coordinators with offices in Germany, Japan and China. This year we are going to futher diversify our way of working adding a team of Clinical Trial Supply Associates located in India.

In the role of a Clinical Trial Supply Associate, you will be responsible for supporting the global Clinical Trial Supply team in the execution of clinical trial supply chain activities e.g., ensuring GxP compliant documentation for the certification of investigational medicinal products by a qualified person or in preparation for inspections by authorities.

**Responsibilities**:

- Support the coordination and management of clinical supply projects, including planning, scheduling, budgeting, and resource allocation.
- Archiving of clinical supply documentation in internal and external GMP and GCP systems ensuring clinical supply documentation meets GxP standards for inspection purposes.
- Organize and control the compilation of documents for approval by the competent person.
- Check (content and completeness) and archive technical specifications, documents, and contract annexes.
- Manage project documentation, including project plans, status reports, and meeting minutes.
- Create and review supply contracts and control budget/invoices approvals within the defined framework. Escalate issues as necessary.
- Support post-trial reviews and identify opportunities for process improvement.
- Assist the Clinical Supply Manager and Coordinator with other project-related tasks as required.
- Ensure full GMP compliance and documentation for clinical supply activities, including returns, destruction, and full global traceability of Investigational Medicinal Products.
- Participating in project meetings and providing support to coordinate project activities.
- Develop and maintain effective relationships with internal and external partners.
- Preparing project reports, presentations, and other project-related documents.

**Requirements**:

- Bachelor's degree in a scientific or related field.
- Extensive knowledge of English with a good command of the technical vocabulary. Excellent communication skills, both verbal and written, with the ability to communicate effectively with stakeholders at all levels.
- 1-2 years of experience in clinical supplies management or other related fields in the pharmaceutical industry e.g., Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs Logistics or Clinical R&D.
- Understanding of GxP and other regulatory requirements related to clinical supplies.
- Strong attention to detail and a focus on delivering high-quality results.
- Excellent analytical and problem-solving abilities with the ability to work collaboratively in a fast-paced and dynamic environment.
- Detail-oriented, organized, and able to work independently and as part of a team.
- Proficient in Microsoft office tool suite (Word, Excel, and PowerPoint).
- Strong attention to data management skills with a focus on quality of documentation.
- Must be self-motivated with the ability to manage multiple tasks, prioritize, and meet tight deadlines.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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