Project Data Manager (ag)

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AMS Advanced Medical Services GmbH is a privately-owned Contract Research Organization (CRO) with over 300 employees and offices in Mannheim, München, acting internationally since 1997 in Clinical Research, Medical Science/Health Technology Assessment and Marketing & Sales in the medical-pharmaceutical industry. Our Clinical Research services for Phase l-lV studies as well as Non-Interventional Studies include Project Management, Monitoring, Data Management, Biostatistics, Medical Writing, Pharmacovigilance/Drug Safety, Quality Assurance, conduction of Audits and support for Regulatory Affairs and submissions. Since 2015 we are actively shaping the EU HTA process in collaboration with our clients and pharma associations and are an established partner to support our clients in preparation and submission of EU HTA dossiers as well as national HTA dossiers.

To expand our team, we are looking for a Project Data Manager (ag) to join us in Mannheim or Munich as soon as possible.

Your contribution:

• Data Management (DM) related tasks of studies
• Project Management
• Interaction with Sponsor & third parties, Clinical Operations, Biostatistics and Pharmacovigilance
• Coordination of all Data Management related activities (from (e)CRF setup until final (e)TMF transfer)
• Creation of Data Management documents
• EDC system setup and validation
• ePRO setup and validation
• Oversight on the creation, maintenance and final transfer of the DM part of the (electronic) Trial Master File and of electronic study data
• Communication and interaction with the study team
• Chairing and documentation of DM meetings
•  Main contact to the Sponsor and third parties for all study related DM issues
• Oversight and delivery of DM study budgets and management of changes to DM budget (out-of-scope activities) during life time of a study
• Reporting of DM study budgets to Team Manager Data Management

 

 

Your profile (ideally):

 

• A degree or equivalent in scientific or health care discipline

 

And

·        at least two years of experience in Clinical Data Management and experience in different study phases

OR

·        at least four years of experience in Clinical Data Management

 

• Profound knowledge of applicable national and international regulations and Good Practices
• Good knowledge of the regulatory framework and methodology of studies
• Very good organizational, interpersonal and communication skills
• Good Project Management skills
• Good presentation skills
• Fluency in English/German (at least C1)
• Ability to work independently and in interdisciplinary teams

 

Our offer:

• The cooperation in a competent, internationally oriented and growing team
• Diversified activities
• Flexible working hours after the introductory phase
• Respectful interaction on equal terms
• On-the-job training and the opportunity to work independently

 

Are you interested?

Apply now directly via our online application portal including information about your earliest possible starting date and salary expectations.

 

https://jobportal.ams-europe.com/ or via Mail Recruiting-Team@ams-europe.com

If you have any questions, please feel free to contact our recruitment team on 0621 700 95 333. 

 

We look forward to receiving your application!

 

Your AMS Recruiting Team

AMS Advanced Medical Services GmbH,

Am Exerzierplatz 2, 68167 Mannheim, Germany

Click here to apply for this position in our job portal