Dr. Doris Greiling

Forschungsdock CRO GmbH ist eine kleine CRO in der Nähe von Hamburg. Wir bieten sowohl Full-Service als auch einzelne Service-Pakete wie Studienmanagement oder Hilfe bei der Sponsor Oversight an

Line Manager of team of Project Manager and Clinical Trials Assistants. Global oversight and acting project manager for international clinical trals, national clinical trilas and non-interventional studies with focus on Dermatology. Development of processes and SOPS to support international trials. Development of cost proposals and participation in bid defence meetings.

Management of and responsibility for international clinical trials (phase III) in respiratory diseases including start-up activities (e.g. feasibility, country and site-selection), study conduct and trial close out including study report . Primary contact for clients and all internal functions, preparation and attendance of bid-defences, budget control

Leading all aspects of early drug development in CNS indications including Treatment-Resistant Depression, Alzheimer's disease, Neuropathic pain. This includes coordination of all activities in preclinical development, clinical study management (Phase I (FIM) and Phase II (up to proof-of concept), budget responsibility.

Responsible for the planning and conduct of clinical trials (Phase III and IV) in respiratory diseases. Coordination of project related activities such as preclinical work, CMC work and regulatory support.

International Study Management in Diabetes (Phase III) including development of international study protocols, set-up and control of study budget. Review of study data for interim analysis and data base lock. Participation in writing of the study report and submission dossier. Coaching of junior staff. Support of the pharmacovigilance team

Management of clinical trials including start-up activities (e.g. submission to regulatory authorities and ethical committees), study conduct and trial close in Germany. Review of draft study protocols and CRFs, preparation of supporting material for investigational sites in local language. Scientific and logistical support of CRAs and project assistants including co-monitoring visits. Selection and training of freelancers and external CRAs.

Responsible for the delivery of a clinical development candidate from target validation up to candidate nomination and hand over to the clinical team. Team leader of up to 5 team members including PhD

Parasitology, Immunology, Microbiology