• Support development of medical plan in accordance to defined timelines
• Coordination and preparation of business reviews for all therapeutic areas in medical affairs
• Overall management and controlling of country annual medical operating plan and respective spending
• Management of insight reports and KPI

Therapeutic area: Cardiology / International, Controlled Clinical Trial, phase III b (IMP in patients with cardiac device), 250 study sites

• Ensuring project progress and reaching of milestones/deliverables and KPI
• Status reporting to sponsor and general management throughout all phases of trial
• Coordination of monitoring activities and quality control, including review of monitoring visit reports and risk assessment across all sites in Europe
• Adaptation of Risk Based Monitoring Plan based on project development / requirements
• Supervision of IMP vendor management and distribution to study sites
• Budgeting: Creation of cost proposal for sponsor as well as budget oversight / adaptation of project budget based on project requirements
• Coordination of billing to sponsor, verification of incoming and outgoing invoices including payment to study sites
• Preparation of and participation in scientific committee meetings (KOL)
• Pharmacovigilance: Adverse event (AE) / Serious Adverse Event (SAE) management, safety assessment and creation of yearly safety report (DSUR)
• Leadership of project team: mentoring, training, quality control, billing of contingent workers

Therapeutic area: Cardiology / International, Controlled Clinical Trial, phase III b (IMP in patients with cardiac device), 250 study sites

• Coordination and quality control of centralized and remote monitoring activities including training and development of company and freelance CRAs, participation in co-visits
• Preparation of and participation in site inspection by local authority as well as post-processing
• Creation and revision of study-specific documents e.g. protocol amendments, patient information and consent forms, in collaboration with CRI?s regulatory affairs department according to SOP
• Selection and acquisition of study sites, contract negotiation with study sites
• Study site risk assessment, creation of action plan and escalation
• Creation and revision of eCRF including user acceptance testing (UAT)
• Pharmacovigilance: AE/ SAE management, coordination of Endpoint Review Committee (ERC)

Therapeutic area: Cardiology, phase IV (IMP) / Therapeutic area: Cardiology, phase III b (IMP in patients with cardiac device)

• Performance of initiation (~ 60), monitoring (~ 100), close out and motivational visits across Europe
• Source data verification, identification of protocol and ICH-GCP violations
• Creation of monitoring visit reports, documentation and resolution of quality issues at study sites
• Primary point for contact for study sites, assisting and training of study teams
• Set-up of new study sites, including collection of essential documents
• Assisting Regulatory Affairs with submission to Ethics Committees and Competent Authority
• Pharmacovigilance: AE/ SAE management

Therapeutic area: Oncology, phase III (IMP) / Therapeutic area: Neurology, phase III (IMP)

• Primary point of contact for assigned study sites
• Performance of monitoring visits and site management of German study sites
• Source data verification, identification of protocol and ICH-GCP violations
• Creation of monitoring visit reports, documentation and resolution of quality issues at study sites

Therapeutic area: Cardiology, phase IV (Medical Device ? adaptive servo ventilation in HF patients)

• Review of reported SAE for plausibility, completeness and data compliance, in-house source data verification
• Preparation of Endpoint Review Committee meetings
• Assistance to study sites for resolution of issues
• Verification and documentation of essential documents

• Patient assessment and creation of treatment plan
• Documentation of medical history and therapeutic progress
• Administrative duties e.g. arranging appointments, answering phone calls
• Optimise the practice?s workflow

• Patient assessment and creation of treatment plan
• Documentation of medical history and therapeutic progress
• Administrative duties e.g. arranging appointments, answering phone calls
• Optimise the practice?s workflow

• Patient assessment and creation of treatment plan
• Documentation of medical history and therapeutic progress
• Administrative duties e.g. arranging appointments, answering phone calls
• Optimise the practice?s workflow