Human Trials Manager (m/w/d), Gaillard

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Tasks

Coordination of Human Trials Supplies

- Lead the Coordination Efforts:
- Oversee the timely and quality provision of prototypes for all types of human trials, ensuring alignment with study timelines and requirements, including manufacturing, packing, labelling and shipping & controlled delivery to study site to ensure the tests samples are produced according to cGMP.
- Establish required documentation with 3rd parties and establish or assist in writing manufacturing & labelling instructions for internal operations.

• Collaborate with Cross-Functional Teams: Work closely with R&D, clinical operations, and other relevant departments to gather trial requirements and ensure seamless supply chain operations.**
• Quality Assurance: Establish and maintain quality standards for prototypes, ensuring compliance with relevant regulations and internal policies.

- SOP Review and Implementation:
- Evaluate Current SOPs: Conduct a comprehensive review of existing Human Trials Supply SOPs and identify areas for improvement to enhance efficiency and simplify processes.
- Support implementation: Lead the rollout and support training for the new Human Trials Supply SOP, ensuring all team members are trained and compliant.
- Continuous Improvement: Foster a culture of continuous improvement by recommending and implementing changes that streamline operations linked to Human Trials.

- Key Working Relation:
- Evidence Generation & Real-World Evidence (RWE) (Basel)
- Innovation Project Managers (Basel)
- All the technical department of GIDC (Gaillard)
- QA Manager (Gaillard)
- 3rd parties

Profile

• Education: Bachelor’s degree in Life Sciences, Supply Chain Management, or a related field. Advanced degree preferred.
• Experience: Minimum of 5 years of experience in Human Trials supply, clinical trial management, or a related field, preferably within the pharmaceutical or healthcare industry.

Skills:

• Strong project management and organisational skills.
• Excellent communication and interpersonal skills.
• Familiarity with regulatory requirements related to human trials and/or cosmetic regulations.
• Proficiency in English essential