Kostenlos inserieren

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

Inserent kontaktieren

Ihre Nachricht:

Ihre E-Mail-Adresse wird nicht an den Inserenten oder Dritte weitergegeben.


Kontakt
+4915 anzeigen   Nummer bestätigt
0622 anzeigen
Nachricht an Anbieter
Informationen
Standort:
Darmstadt Umland, Hessen
Anzeige Nr:
00829832
Besucher:
501
Über den Inserenten
Benutzername: riswalldor
1095 weitere Kleinanzeigen
Neu Hier?
Einfach, hilfreich, kostenlos!
Jetzt Mitglied werden und Findix vollständig nutzen.

Diese Kleinanzeigen könnten Sie ebenfalls interessieren:

Archiving Associate (m/f)

Archiving Associate (m/f)


We are searching on behalf of an international pharmaceutical / chemical company for administrative support in a medical environme...

 08.08.2016
64283 Darmstadt
Specialist Customer Service International (m/f) for Darmstadt asa

Specialist Customer Service International (m/f) for Darmstadt asa


On behalf of our client in Darmstadt we are looking for consultants to support our clients support. The position is based in Darms...

 
64283 Darmstadt
Research and Support services for Japanese speaking in Walldorf i

Research and Support services for Japanese speaking in Walldorf i


On behalf of our international successful client we are looking for a Japanese speaking candidate to support our client. The posit...

 
69190 Walldorf
Clinical Research Fellow in General Internal Medicine 100 %

Clinical Research Fellow in General Internal Medicine 100 %


Clinical Research Fellow in General Internal Medicine 100 % Beginn sofort oder nach Vereinbarung Tätigkeit •Teilnahme an klini...

 29.01.2016
90584 Allersberg