International Clinical Trial Manager (ICTM), in Oncology

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.The Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of clinical trials (Phase I through IIIB) in compliance with GCP’s, SOPs and established timelines. The CTM is involved in the scientific conduct of the clinical trial and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with the Clinical Research Director (CRD). This role is expected to include international responsibility. Travel, including international travel, is expected to be approximately 20%.Duties and Responsibilities
May lead the Clinical Trial Team (CTT), including representatives from CRA’s/CRO’s, Data Management, Pharmacovigilance, Therapeutics, Biostatisitics, Pharmacokinetics and other relevant departments for the logistical aspects of the trial.
Collects from collaborators (e.g., CRUs, CROs, other vendors), synthesizes and reports trial progress information.
Tracks clinical key points (i.e., efficacy, safety. pharmacokinetic, pharmacodynamic parameters) and, when applicable, coordinates the centralized review procedures.
Assists in the evaluation and planning of adequate resources needed to perform the trial.
Reviews protocols and amendments (operational sections) to verify feasibility. Develops and validates Case Report Forms in conjunction with Clinical Data Management and the CTT.
Assists local monitoring teams in organization and management of study sites.
Develops and validates the Monitoring Plan for the study in cooperation with CTT
Participates in the development of the clinical trial budget by defining tasks and responsibilities of external resources, estimating costs of logisitcal aspects of the trial and tracking payments for operational aspects of the trial.
Collaborates in the data collection, review and processing function.
Ensures the proper filing, maintenance and archiving of study documentation.
Estimates global need for investigational product (IP) and collaborates with the International IP Dept to validate IP specifications, packaging, shipment (including resupply) and reconciliation process.
REQUIREMENTS
Knowledge and Skills
Expected to interact effectively with scientists and managers from disciplines; serves as internal consultant on assigned area and liaise with outside agencies on projects.
Familiarity with computer systems
Excellent interpersonal and communication skills (verbal and written)
Self motivation, attention to detail and organizational skills important.Formal Education/Experience
Bachelor’s degree (advanced degree preferred) and seven or more years of laboratory or medical experience (or equivalent), including 5-7 years of clinical research experience in the pharmaceutical industry (or equivalent) is required.
Prior management or supervisory experience in clinical operations are desireable.
Oncology Phase I Therapeutic Area experience desireable.