Dr. Thomas Portele

Co-ordination and management of large cross-functional multinational studies and project teams. Development of full service project plans for a program of clinical trials in accordance with contractual timelines, budget and according ICH/GCP. Risk management to critical path for drug development and risk mitigation. Change in scope management as well as contract negotiations with clients. Input to proposals and participation in Bid Defense meetings. Resource management and line management of managers.

Poistion includes providing leadership to effectively co-ordinate and manage the activities of one or more large cross functional multinational studies or a program of studies and project teams in a manner that ensures all timeframes and targets are met and that costs are kept under control. Indication: CNS. Participate in business development activities including bid defense and proposal activities.

Responsible for the overall coordination, implementation and completion of regional/global cross-functional projects including consistency with ICON SOPs, study contracts and budgets. This includes: Primary point of contact for and responsible for developing successful working relationships with clients. Mentoring and training all project personnel. Participate in business development activities including bid defense and proposal activities. Indications: CNS and Oncology.

Responsibilities include: acting as the functional lead from clinical operations with overall accountability for site selection; site start up; patient recruitment; site monitoring; data retrieval and study close-out. Responsible for risk mitigation strategies, associated action plan and issue resolution. Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards.

Responsibilities include: oversight of site selection; site start up (including submissions and Investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. Responsible for risk mitigation strategies and development of cross-functional project management plans. Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards.. Indications: CNS and Oncology.

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Acting as Project Manager responsible for two Oncology trials (Europe). Oversight of a cross-functional team (clinical, data management, biostatistics, medical, lab). Accountable for study delivery, quality and budget from maintenance to close out.

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP. Involvement in other areas of study management and staff training. Contribute to the review of ICON systems and procedures.

Basic research in thrombosis and haemostasis. Development of new models for thrombosis and haemostasis research. Ongoing supervision of students and conduct of seminars at the University of Jena Germany.

Promotionsarbeit in der Herz-Kreislaufpharmakologie der Schering AG Berlin, Abschluß "summa cum laude"

Diplomarbeit in Onkologie am Max-Delbrück-Zentrum in Berlin Buch