Human Samples Management Scientist

Human Samples Management Scientist at Evotec(Clinical Research Scientist) (H/F)

18 months Temporary contract

We are seeking for a highly motivated clinical research scientist with a strong expertise in translational biomarkers and clinical research.

In the Translational Biomarkers department the candidate will be responsible for managing human sample collection and associated clinical data ensuring compliance with regulatory standards and company policies. This role involves designing and conducting clinical studies to gather highquality human samples while also overseeing the import/export authorization processes. The candidate will play a crucial role in bridging scientific research and regulatory requirements contributing to the advancement of translational biomarker projects.

TASKS:

• The successful candidate will collaborate in a multidisciplinary research team in an exciting fastpaced discoveryoriented environment and at the interface of several departments Evotec sites and with several hospitals.
• The candidate will work in the Human Sample Management team that guarantees the ethical and regulatory compliance of donor and patient samples at international level. In particular the candidate will be responsible for setting up and managing import/export authorizations in collaboration with the other departments involved.
• The candidate will analyze evaluate and approve research intent regarding restrictions applying to human samples in collaboration with the line manager.
• The candidate will help to implement all documentation regarding work on human samples in accordance with the quality standards of the company.
• The candidate takes charge of the logistic aspects for collection of data to the clinical center until their integration in a database in compliance with GDPR.
• The candidate will also manage relationships with clinical centers including Oncopole with internal customers and regulatory affairs to ensure legal compliance at the level of his/her responsibility

• With the help of their line manager the candidate will set up and coordinate prospective clinical studies (RIPH) helping in evaluation of the feasibility create the design schedule and follow up.
• The candidate writes the associated operating procedures in close collaboration with the clinical units involved and manages the documentation and the internal archiving.
• With the help of their line manager the candidate should be the link between clinical centers and the project leader to develop and update the workflow of the human samples and associated clinical data.
• The candidate will contribute to a good relationship with clinical partners.
• The candidate should be a team player flexible autonomous and able to work in a matrix environment with other teams.
• The candidate will present results in English to project team leaders and stakeholders at the several clinical centers.

PROFILE:

• Autonomy proactive behavior and team spirit
• Rigor and multiskilled
• Dynamic openminded
• Excellent communication skills diplomacy
• Ability to work in transverse and multidisciplinary teams and adaptability

EDUCATION AND EXPERIENCE :

• PhD in Biology with a focus area on clinical trial implementation management and monitoring of clinical studies and associated clinical data and samples. Alternatively a Medical background with similar focus area.
• Multiyear experience >5 years) in establishment and management of collaborations in the clinic regarding management of human samples and associated clinical data

COMPETENCES:

• Experience in implementation and management of the workflow to guarantee the ethical and regulatory compliance of human samples and notably in the implementation management & followup of the import/export authorizations with French Ministry
• Ability for project management needs assessment plannings studies follow up (timelines and deliverables)
• Demonstrated ability to work on crossfunctional and multidisciplinary projects
• Able to work on multiple projects simultaneously. Ability to organize and communicate project plans in a clear and concise manner to key stakeholders from diverse backgrounds
• A dual experience in basic research/clinical research: knowledge in BPC / BPL
• Experience in international regulations governing research in human samples.
• Experience in French regulations regarding the collection of human samples and data (Jard law GDPR).
• Experience in quality management will be a plus.

LANGUAGES:

• Fluent French: required
• Fluent English: required

EXPERIENCE:

• Min 5 years experience in translational and/or clinical research
• 12 years experience in hospital/Biological Resource Center

FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.