Description
We are looking for a
Registry Manager (m/f)
Reference: -en
Start: asap
Duration: 11 MM
Place: in Zug
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Responsible for managing or supporting the management of Registry Outcome Surveys conducted within the global clinical development group
- Managing and supporting the operational activities of the registries (observational/non-interventional studies)
- Responsible for leading cross-functional team members to coordinate appropriate and timely completion of registry-related activities
- Manage all operational aspects of the registries from start-up to close-out activities to assure adherence to timelines and achievement of goals while ensuring compliance with FDA, EMA, ICH/GCP, GPP and other applicable guidelines/regulations
- Coordinate and manage global and local activities, e.g. as point of contact for sites when needed or by reviewing monitoring reports, draw-up of study materials/documents, providing oversight of tracking of registry activities (e.g. contracts, ICF, EC/IRB submissions, decision logs)
- Support the Registry Lead to ensure registry objectives are properly prioritized
- Encourage active participation and involvement of registry investigators in all regions
- Identify and develop new registry sites together with the Registry Lead and Global Medical Affairs
- Participate in and conduct visits and meetings with investigative sites, physicians and consultants, as needed
- Contribute to the selection of vendors
- Ensure successful conduct of registries by coordinating vendors' daily activities, including timelines to ensure data integrity and quality
- Define and monitor the budgets and contracts with CROs, sites or other vendors
Your qualifications
- Degree in the scientific/health care field is required
- Background with demonstrated success in clinical project management in the pharmaceutical industry or with CROs
- Experience in managing GCP studies
- Experience with observational/non-interventional studies preferred
- Strong organizational, IT and writing skills, as well as strong attention to detail
- Experience in building relationships with physicians/centres, in particular KOLs
- Experience in managing external expert groups
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager