Senior Clinical Trial Manager

Very strong experience in Global Clinical Operations and Clinical Regulatory Affairs (day to day clinical trial management, selection of CROs and investigational sites, contract negotiation, writing dossiers, defining the clinical development strategy, writing briefing books for EMA and local authorities etc.)

Experience in Phase I-IV, Non-Interventional Studies, and IITs; accompanied EMA submissions for marketing authorizations; participated in due diligence; deep understanding of ICH-GCP; broad knowledge in QM and Regulatory Affairs

Therapeutic areas: Infectious diseases, vaccines, oncology (hematology / solid tumors), cardiovascular diseases, immune system diseases, skin, and connective tissue diseases

Guidance on clinical study implementation and provision

Ensuring all relevant timelines, budget management and proactive advice on deviations from the study plan

Participate in team meetings, provide advisory input, and translate conclusions into project milestones

Proactive management of CROs and vendors, including risk management, escalation, and negotiations

Advice on the collection of key figures

Decisions and corresponding preparation of key figures, reports, and presentations

Manage risks for all consulting tasks

Advising the internal clinical trial managers as well as all external service providers

Coordination of activities and organizational contact person at the centers as well as at the CRO

Identification of performance issues at the centers and CRO as well as quality issues at the patient level

Proactively monitor processes to ensure a speedy start of studies

Provide guidance and encouragement on study feasibility

Ensure smooth logistics for study samples

Point of contact for the site: develop and maintain productive relationships

Provide feedback to Internal and External Stakeholders as appropriate

Proactively oversee startup processes to ensure rapid study initiation, working with CRO to overcome delays

Support and drive in-country / regional study feasibility

Build strong ties with clinical site staff and investigators for optimal sponsor-site relationships

Ensure high quality by managing country-level issues and deciding when to escalate to the global study team