We are excited to see you are interested in working for A4P.
As a diverse and engaging workplace, we are always looking for forward-thinking and motivated people to join our teams.
Why work for us? Our success to date is all due to our employees who we hope to inspire and develop while working in their chosen roles. We thrive to provide our employees with the best work-life balance through ensuring flexibility and help where needed.
Working within a Translational Medicine department of one of our clients, we are looking for a highly motivated individual to coordinate the preparation, implementation, and follow-up of biological analyses (ie PK, PD and biomarkers) in clinical trials in close interaction with Translational Medicine scientists, Clinical Study managers, Clinical Leads, Medical Directors and CROs. The successful candidate will be autonomous, proactive and collaborative with experience working in a clinical development environment.
The responsibilities will be to:
- Contribute to the preparation of biological analyses in clinical trials by
- participating to the selection of analytical laboratories (including service providers and/or commercial partners),
- managing contracts with the support of a legal advisor,
- planning and following-up the activities related to the implementation of biological analyses in clinical trials (e.g. assay transfer, kit preparation, sample collection procedures, shipping requirements, CRF review, analytical data collection/reporting and data transfer) with different service providers.
- Follow-up and monitor the activities related to biological analyses during ongoing clinical trials (including coordination with the central lab and the other laboratories, follow-up of samples), identify study or project issues and solve them. Contribute to the preparation of the budget related to these activities as well as its follow-up.
- Collaborate on the transfer, review and analysis of the corresponding results and ensure appropriate data review and accurate data reporting.
- Support the development of dedicated sections of interim analysis and study report.
- You hold a Bachelor or Master degree in Life Sciences or PharmD.
- Ideally, you have a minimum of 3-year experience in organizing, implementing and monitoring analysis of biological markers during clinical trials, but candidates with less biomarker specific experience who have extensive experience in clinical operations will also be considered.
- Experience in oncology/immuno-oncology is an advantage.
- Prior experience in a laboratory environment is important to be able to coordinate experiments in clinical settings.
- Experience in the follow-up of contractual aspects and relations is an advantage.
- You have strong problem-solving skills
- You are open-minded and have excellent interpersonal and communication skills.
- You have a good understanding of GCP/GCLP guidelines and current global regulations.
- You are fluent in English (oral and written), French language would be useful.
- Well organized and resilient, you are able to adapt to changes in priorities and to work effectively on multiple programs in a fast-paced environment.
- Although largely autonomous, you are collaborative and are happy to work with internal and external stakeholders.
- You master Standard Office tools (knowledge in MS project is an asset.
- Since the job scope/role could evolve as the company grows, you can adapt to changing needs.