Clinical Bioanalytical Monitor

We are looking for a Clinical Bioanalytical Monitor who will undertake complete bioanalytical strategy with different vendors and CROs.

You will be responsible for all outsourced activities for bioanalytical support of small molecules from selection of vendors to reviewing of CRO performances. This is an 8 month assignment with extensions in place. Please note that German is a must for this position as you will be interacting with vendors and CROs.

Responsibilities:

- Take the full responsibility of outsourced activities for bioanalytical support of small molecule, LMW compound from FiH till post marketing.
- Will be in charge of numerous projects
- Manage the complete bioanalytical strategy with different external vendors
- Independently analyse and interpret data from different experiments performed by external vendors.
- Draw relevant conclusions and design next experiments/validations.
- Supervise independently the outsourcing process for clinical studies sample analysis: provide input to clinical documents, coordinate internal and external timelines and monitor quality of data generated by external vendors.
- Interact with PK expert, project teams and ensure proper priorities of activities at CROs.
- Participate in meetings for Bioanalytical outsourcing strategy, selection of external vendors and review of CRO performances.
- Act as BA subteam member in PKS PTM team from FiH onwards.
- Provide regulatory document (eg CTD2.7.1) for submission

Educationemail.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.