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Location: Munich office or homebased Germany
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Mapi is the leading Patient-Centered Research company serving academia, life science researchers, and the pharmaceutical industry. Our commitment to patients is reflected through our wide range of services, including Real World Evidence, HEOR, Linguistic Validation, Global Market Access, and our Mapi Research Trust. Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. |
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Your Responsibilities and Accountabilities:
Responsibilities:
- Perform site feasibility and site selection in conjunction with the Study team, or independently
- Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiations
- Perform onsite and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirements and assure appropriate site performance
- Provide timely and accurate visit reports as specified by project specific timelines.
- Contribute to sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings
- Maintain regular site contacts to ensure site compliance, enrolment and understanding of study requirements
- Maintain the Project Tracking System recording site visit dates, site contact notes, subject and site information
- Maintaining high quality standards, including identifying areas for improvement where applicable
- Assist with the development of departmental and project specific processes and procedures.
- A background as a CRA, ideally within late phase studies but not essential
- Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)
- Proficiency with computer/software systems
- Proven ability to manage multiple simultaneous tasks
- Fluency in both written and spoken English and German languages.
- Bachelor degree or higher preferably in a scientific, medical or life sciences discipline
At Mapi, we embrace our values, and everyone that works here is expected to demonstrate these values and associated behaviors in their day-to-day work. Our values are the foundation of the work we do and include Integrity, Efficiency, Taking an Interest in others and having a Pioneering spirit.
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