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| Entreprise: |
Kelly services (Suisse) SA |
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| Intitulé: |
Clinical Project Leader |
| Secteur Emploi: |
l'industrie Pharmaceutique |
| Localisation de l'emploi: |
Suisse |
| Description: |
As per need, participate in developing and reviewing documents related to Clinical studies, including Clinical Trial Outlines, Clinical Protocol Synopses, Clinical Protocols, Amendments to Clinical Protocols, Informed Consents, CRFs, Clinical Study Reports, Laboratory documents, Confidentiality agreements, Investigator agreements, Safety updates and other relevant documents.
Define and negotiate terms and conditions for outsourcing of clinical trial activities to Contract Research Organizations (CRO) or other external vendors, and track deliverables and performances.
Assume ambassadorial role to develop excellent relationships between sites and line functions and increase value proposition to investigators.
Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial.
Ensure site preparation, initiation and training through in-house resources or outsourcing.
Implement total site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance through in-house resources or outsourcing.
Track trial execution milestones; identify problems; resolve issues and escalate as appropriate.
Manage recruitment and execute contingency plans, as needed.
Ensure preparation/generation/review/follow-up of study monitoring reports through in-house resources or outsourcing.
Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets.
Ensure site close-out activities through in-house resources or outsourcing.
Act as a mentor to new associates.
Participate in multi-disciplinary teams to evaluate and implement process improvement in Europe and globally.
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| Capacités Requises: |
Professional Profile
Nurse degree, Pharmacist degree, Medical degree, or equivalent higher natural science education.
At least 5 years (1-2 years in monitoring, 1-2 years in coordinating, 2-3 in project management) in Clinical Research in Biotechnology or Pharmaceutical or CRO, ideally having worked in a matrix environment
Multidisciplinary understanding of pharmaceutical clinical research and development processes.
Deep knowledge and understanding of Clinical Research requirements and regulations (GCP/ICH) on European (EMEA) and single country level, with understanding of the US environment being a plus.
Solid knowledge and experience of clinical trial design, trial execution and operations.
Track record of pan-European Clinical Research activities.
Experience from adult and pediatric clinical research in various Therapeutic Areas is desirable, due to the high complexity of driven projects, a sound knowledge of complex pathology (immunology, oncology, haematology) is required.
Experience from Orphan Drug clinical research is desirable.
Excellent computer skills using Project Management programs, Word, Excel, PowerPoint
Excellent project management skills.
Travel required up to 30% |
| Langues Requises: |
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| Type de Contrat: |
Temps Plein |
| Salaire Annuel: |
Non spécifié |
| Date d'Affichage: |
2009-10-09 |
| Niveau d'Etudes: |
Non spécifié |
| Années d'Expérience: |
Pas d'expérience |
| Entreprise: |
Kelly services (Suisse) SA |
| Nom: |
Kelly Scientific Resources |
| Téléphone: |
0041 22 737 12 06 |
| Fax: |
0041 22 737 12 13 |
| Methode de Contact Préférée: |
E-mail |
| Preferred Language of Resume/Application: |
French |
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