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Project Director-Clinical Operations. Basel-Stadt. Suiza
Oferta en Suiza (Basel-Stadt) de Biólogos, botánicos, zoólogos
Clasificación del trabajo: Profesionales científicos e intelectuales › Profesionales de las ciencias y de la ingeniería › Profesionales en ciencias biológicas › Biólogos, botánicos, zoólogos y afines.
Traducción de la profesión: Akademische Berufe › Naturwissenschaftler, Mathematiker und Ingenieure › Biowissenschaftler › Biologen, Botaniker, Zoologen und verwandte Berufe.
Descripción de la oferta de trabajo:
The Project Director-Clinical Operations oversees, manages and/or coordinates conduct of multi-national clinical trials which are complex in nature and in compliance to applicable regulatory framework. Provides strategic direction to project team (consists of internal and external stakeholders) for execution of clinical studies worldwide.
Main tasks:
Lead CRO/Vendor Identification, Evaluation and Selection Process
Strategic Inputs in planning and execution of clinical trials
Contribute to various functional capability building initiatives
End to end vendor management
Project and governance reviews (PTM, Governance, Asset review etc.) including Project Budget review
People Management
Education: Master /Bachelor Degree in life sciences or allied medical fields (e.g., B. Pharm./M. Sc. (Life science)/ M. Pharm./M.B.B.S./Ph.D.)
Experience: Minimum of 12 years of clinical research/ operations experience in the Pharmaceutical, Biotechnology, Medical Device and/or CRO industry is required
At least 2 years in Biosimilar studies and 5 years of people management with increasing levels of responsibility,
Five or more years of clinical program management experience at a sponsor or CRO company
Prior line management experience is required.
Prior monitoring and clinical project management experience is required.
Therapeutic experience in oncology/ Auto immune disorders (preferred)
Experience in early phase trials (Phase I-II) and First-In-Man trials (preferred)
Knowledge: Different Therapeutic Areas (Oncology, Rheumatology, Dermatology etc.) ; Treatment options;
Advanced knowledge of FDA guidelines, ICH, GCP, and other applicable regulations as well as IND / NDA
Knowledge of clinical trial management software products (e.g. CTMS, EDS, IVRS, eTMF, etc.)
Basics of clinical development;
Budget forecasting,
Basics of Quality, IP supply and Management,
Vendor relationship management and governance
Skills:
- Negotiations and Cross cultural sensitivities
-Excellent verbal and written Communication in English
-Ability to Influence and decision making skills
-Innovation and Problem solving skills
Ability to align cross functional teams for successful execution
País del trabajo: Suiza.
Región: Basel-Stadt.
Ver 20 ofertas de trabajo en "Basel-Stadt" (Suiza).
Número de puestos: 1.
Empleador: Dr. Reddy's Laboratories SA.
Instrucciones para solicitar:
hrbaseldrreddys.com
Forma de contacto:
- Teléfono: +41 61 271 47 54
- Sitio web: hrbaseldrreddys.com
Oferta de trabajo obtenida del portal Eures, con fecha 29 de Diciembre de 2023, y con identificador de la vacante:6cb71a45-92bc-11ee-b567-a6afd4464b0f.
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