Dr. Elke Ufer

Plan and execute compliance assessments Provide consultancy and advice for quality-related questions to Clinical Research staff. Ensure Standard Procedural Documents are maintained and up-to-date. Provide general support in preparation, conduct and follow-up of audits and inspections. Actively contribute to Vendor Assessment / Qualification process Perform formal quality reviews of computerized system validation documentation and improvement of validation processes

In addition to previous function: • Approve SOPs • Approve Study Site Opening • Build up a Quality Management group (find good candidates for this group, train and manage those) • Coordinate Quality Management activities within the department In addition: • Contact person of the Clinical Research Department of Boston Scientific to EUCOMED • Involved in ISO 14155 review

• Quality Management at Clinical Research Department International of Boston Scientific • Ensure compliance of clinical trials • Answer all quality related questions on a daily basis • Review/Align/Optimize SOPs • Ensure appropriate Training of clinical employees • Function as trainer for clinical employees (Regulations, Guidelines, Standards, SOPs) • Review of study protocols and other study documents • Identify process issues and ensure appropriate solution • Coordinate Quality Management activities

• Building up a monitoring group (started alone as the first monitor). • Monitoring of clinical trials. • In-House monitoring (intra departmental quality control). • Developing / Review of Standard Operating Procedures. • Training / coaching of new monitors. • Exchange experience and align processes in contact with US Monitoring Group.

• Site Management • Technical support at clinical sites for implants and patient follow up • Training of FCRE and Sales colleagues (new implantable lead and new implant procedure) • Training of customers at site and in-house (new implantable lead and new implant procedure) • Support Data Collection at Clinical Sites • Monitoring of closed studies (some closed > 3 years ago)

• Monitoring of clinical trials. • Clean up and archive closed trials. • Develop routine monitoring process. • Support Sales Force in software up grade of programmer devices in hospitals.

• Develop / review Clinical Trial Documents, e.g. Protocols, Case Report Forms. • Coordinate trial preparation, e.g. Ethic Committee / Competent Authorities Submis-sion. • Manage trial performance in close contact with sponsor. • Train, coordinate and supervise Clinical Research Associates assigned to the projects. • Review study reports. • Organize Investigator Meetings. Clinical Research Associate (1995) • Monitoring of clinical sites. • Site Initiation Visits. • Data entry into database.

Zoologie, Parasitologie

Molekulargenetik