Clinical Trial Lead (Sponsor) (PR-32916025)
Sie bringen mehrjährige Study Management-Erfahrung mit und suchen ein freiberufliches Projekt bei einem innovativen Biotech-Unternehmen? Dann ist folgende Position bestimmt sehr interessant für Sie: Wir suchen für einen unserer Kunden - ein großes Biotechnologieunternehmen in München - einen Clinical Trial Lead:
General Accountabilities
- Leads Clinical Trial Team in operationalizing protocol and driving protocol
- Creates trial level timelines and ensures all trial deliverables are fully executed
- Ensures all trial related documents including operational plans and systems
- Manages trial allocation and coordination/management of activities leading to the selection and initiation of sites
- Ensures trial-level and site-level readiness for first site initiation
- Prepares, implements and manages vendors including their sub-contractors and ensures oversight of trial activities outsourced to vendors
- Manages and coordinates Investigational Medicinal Products (IMP) and non-drug supplies across regions and countries and ensures final drug accountability
- Collects, tracks, and communicates trial status for enrolment, timelines, data entry / queries, trial materials; provides updates to relevant internal / external boards
- Manages trial budget including completion of grant plan specifications, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out
- Collaborates with CTT to define the scope of responsibilities of operational and medical/clinical data review within the data management plan, or equivalent, to ensure ongoing quality data review
- Ensures inspection/audit readiness including trial master file documentation
Job Qualifications
- BS required in a life science discipline (i.e. Biology, Chemistry); MS, PharmD, or PhD
- 7+ years of Clinical Trial operational experience in planning/executing/reporting clinical trials
- Thorough & working knowledge of Good Clinical Practice, regulatory processes, and clinical development process
- Excellent English - German as a plus
Haben Sie Interesse an dieser Stelle? Dann freue ich mich auf Ihre Bewerbung!
Herzliche Grüße,
Stefan Blöchl
Pharmazie, Pharma, Medizin, Medical, Biologie, Onkologie, Orphan, drug, Master, Bachelor, GCP, GxP, Clinical, CRO, Studien, klinisch, TMF, Prüfplan, Prüfbogen, Monitor, CRA, CTA, Clinical Research Associate. Trial Master File; GCP, GxP, Clinical
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