Expert Clinical Supply Services

3 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.

**Expert Clinical Trial Supply (Team Lead)**

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

Leading a team of Clinical Trial Supply Associates, you will be ensuring high quality and timeliness of the work of your team by providing clear direction, guidance, and support to team members. Focus of the team is 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**:

- Supervise and support a small team of CTS-Associates and ensuring high quality and timeliness of the work of your team.
- Provide clear direction, guidance, and support to team members, ensuring they understand their roles and responsibilities.
- Ensure full GMP, GDP and GCP compliance of the work of your team
- Collaborate with the team of Clinical Trial Supply Coordinators to manage the clinical supply chain for assigned clinical trials with a focus on ensuring documentation meets GxP standards for inspection purposes.
- Develop and maintain effective relationships with internal and external partners
- Provide support to other members of the Clinical Supplies team as required
- Collaborating with the team on different projects
- Participating in project meetings and providing support to coordinate project activities
- Creating and maintaining project tracking tools
- Preparing project reports, presentations, and other project-related documents
- Handling project-related administrative tasks
- Assisting in the management of project budgets, timelines and ensuring completion of deliverables within budget and time constraints
- Ensure adherence to study budget and escalate issues as necessary
- Other duties as assigned
- Support global clinical supply chain process improvements
- Assist in the maintenance of complete and accurate clinical supply documentation, including batch record review and reconciliation

**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.
- 3-4 years of experience in clinical supplies management or other related fields in the pharmaceutical industry e.g., Manufacturing, Packaging, Quality Control, Quality Assurance, Regulatory affairs, Logistics or Clinical R&D
- Experience in participation and leading project teams in the clinical, clinical supply or CMC environment
- Detailed knowledge of international GMP, GDP and GCP rules, and other regulations related to Clinical Trial Materials
- Strong attention to detail and a focus on delivering high-quality results.
- Excellent analytical and problem-solving abilities
- Ability to work collaboratively in a fast-paced and dynamic environment
- Highly motivated, self-starter with the ability to work independently
- 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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