Jobbeschreibung

Positionsnummer / Reference Number

PA1200406112020

Position / Job Title

Clinical Trial Leader

Aufgaben / Tasks

- Definition and update of clinical development plan
- Prepare and/or review study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g. Clinical Protocols, Informed Consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
- Partner with internal and external experts and consultants
- Review, analyze and interpret the results of clinical programs in collaboration with relevant experts
- Provide medical/clinical input into and review of regulatory documents, during development, submission, and defense
- Ensure that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
- Develop and manage group of studies for an entire business unit or large development team

Qualifikationen / Qualifications

- Bachelor’s degree required, preferably in the life sciences, clinical or other relevant technical areas
- Advanced degree desirable (e.g. MS, PhD, MPH, PharmD, MD)
- Minimum of 4 years study management experience
- Minimum 5 years of clinical study experience, especially in pharmacokinetic / bioequivalence trials, including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies
- Profound knowledge of GCP regulations, clinical trial concepts and practices, including international clinical research guidelines
- Advanced understanding of clinical medicine, clinical pharmacology, and associated disciplines (eg, biostatistics)
- Ideally experience in clinical development of transdermal patches

Weitere Informationen / Further Information

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