Clinical Team Lead/Study Manager sponsor dedicated
Great opportunity to benefit from both CRO and sponsor side: Have the benefits of working for an international team, enjoy working on the sponsor side!
As Clinical Team Leader/ Study Manager you will be able to interpret data on project issues and make good business decisions with support from experienced team members or line management. Maintain profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
· In conjunction with the project manager prepares, organizes and presents at Investigator Meetings.
· Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
· Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File
· Responsible for the implementation and training of standardized clinical monitoring processes according to corporate standard policies.
· Provides regular status updates to PM for client reports.
· Reviews monitoring visit reports and ensures finalization is within contractual timeline.
· Manages CRF collection and query resolution process
· Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met.
· Leads regular conference call meetings with monitors and other clinical team members.
· Participate in bid defense meetings.
Knowledge, Skills and Abilities:
· Superior organizational skills
· Demonstrated performance management abilities
· Extensive monitoring experience
· Excellent judgment and decision making skills
· Effective oral and written communication skills
· Excellent interpersonal skills and problem solving ability
· Ability to motivate and integrate teams and teach/mentor team members
· Able to effectively prioritize workload
· Able to communicate in English, both orally and in writing
If this sounds appealing to you, please contact Franzi Dunker via email email@example.com or via phone +49 69 274 015 840. The applications will be handed with discretion.