Clinical Project Leader

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 primary role of the Clinical Project Leader (CPL), is to act as the key operational interface with internal and external services to develop, implement, maintain and improve operational processes for US clinical trial conduct. This position supports the US Clinical Research physician, medical advisor (MA), in the conduct and management of clinical trials in the US. Supervises in-house Clinical Research Associates (CRA's), Clinical Project Assistants (CPA's), contract CRA's, and coordinates activities of Regional CRA's for US clinical trials with awareness of related functions and roles. Significant operational planning and analysis is required.Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s) in the US.?Interface with corporate CTMs, Regional CRA Team, CRPs and TMs for operational input for feasibility, trial design/methodology, standard US medical practice and data capture.Develop and manage the US trial budget. Overall responsibility for negotiation of financial aspects of clinical trial.Collaborate with medical function in the safety evaluation of study subjects in ongoing trials.Ensure all aspects of study site management are conducted appropriately, i.e. initiations, co-monitoring. Contribute to operational details in specifications for local contracts with CROs, as needed. Ensures adherence to contractual obligations of CRO relative to site management and study conduct, as appropriate.Management responsibility of in-house CRAs, CPA's and business support. Responsible for mentoring and team cohesion.Recruits/oversees recruitment of qualified investigators, evaluation of study sites, conduct of Investigator Meetings (US-only studies). Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies.Fulfillment of project timelines and patient accrual goals is primary goal/challenge. Motivating team effectiveness and communicating with Regional Teams and Management Teams is also high priority goal. [Partnering, mentoring, overseeing, responding proactively will aid in problem solving.Operational planning and oversight for project involves broad decision-making responsibilities.
REQUIREMENTS
Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines. Operational planning experience interpersonal and communication skills (verbal and written), including proficiency in medical terminology. Professional demeanor with ability to interact effectively with scientists and managers from multiple disciplines; serves to provide internal operational expertise on assigned area and liaise with external organizations specific to clinical trial. Strong organizational and time management skills. Self motivation and attention to detail.CPL: Bachelor's degree (advanced degree preferred) and prior management/ supervisory experience in clinical operations. Minimum 3 years experience in pharmaceutical industry and minimum 5 years in clinical research environment.