Archiving Lead / clinical research support (m/f) for Darmstad asa

On behalf of our international successful client we are looking for initial six month to support the clinical research center. The department is responsible for innovative small molecules and biopharmaceuticals and consists mostly of Research, Clinical, Marketing, Support Functions and the Divisional Management.

KEY ACCOUNTABILITIES
- Accountable for implementation of a global archiving project
- Ensure a global structure and process for archiving all essential documents from clinical trials is developed
- Lead TMF supporting process development, as appropriate
- Accountable for the Management of all Trial Master File across various functions
- Coordinate TMF report development to track and oversee status of archived essential documents
- Ensure process considers that documents requested for submissions and inspections are made available from archive
- Ensure that a record of essential documents is available
- Provide reports on outstanding documentation on a consistent basis to ensure integrity of TMFs
- Manage the legacy archive by overseeing and coordinating shipment to a central archive
- Understand the regulatory and legal requirements for archiving across the major Geographic’s (GCP)
- Develops harmonized global processes to ensure that essential documents from Clinical Trials are placed in a system and made available for inspections and submissions
- Lead assigned team members
- Cooperation internally with the Clinical Operations Teams and the GCO Management Team. Externally with Service Providers (CROs), External auditors/inspectors, Regulatory agencies and Industry organizations
Please forward your CV to Tom Sander or apply with our online portal or via mail. If you have any further questions please do not hesitate to contact Tom Sander.
Randstad
Dietmar Hopp Allee 8
69190 Walldorf
T +49 6227 765159
M +49 1522 2726018