Odom Lewis

This candidate currently holds the title of Clinical Research Project Manager at a healthcare communication company and has a PHD in Pharmacology.  This candidate has the talent to help drive revenues whether pitching to new clients or working with existing clients to develop business organically. He can easily handle a variety of disease states enabling coverage of more than one account, and has a solid handle of pre launch strategies. Furthermore this talent understands both US and global perspectives and cultures.  Also he has resided in the Europe for the last 15 years.

This candidate has helped drive revenue as the medical and scientific lead on new business wins, which covered a broad range of disease categories and therapeutic areas.

Pilot, Pivotal, Post Marketing studies

• Cardiovascular devices
  • Heart Failure
  • Heart pressure monitoring devices
  • Drug Eluting Stent
  • Paten Foramen Oval closure device
• Orthopaedic Implants (knee, hip)
  • Knee implants
• Spinal Implant
  • Posterior spinal implant
• Gastrointestinal devices
  • Magnetic Oesophageal sphincter (GERD)
  • Magnetic Anal Sphincter
• Genecology devices
  • Implantable gynaecology devices
• Metabolic disorder
  • Glycaemia record and insulin pump device (Diabetes)
  • Hypoglycaemia alarm device

Discovery: Preclinical and Phase I

• Cardiovascular System diseases (Pharma)
  • Hypertension
  • Heat failure
  • Myocardial infarction
  • Stroke

Discovery: Preclinical  Phase I and Phase II

• Central nervous System diseases (Pharma)
  • Anxiety
  • Depression
  • Schizophrenia
  • Alzheimer
  • Parkinson

• During his tenure with his current firm he has built a strong in-house team of CRA and Project Managers through recruitment and staff development. He has led the creation of a staff training program to utilize their deep clinical and scientific understanding and market-centric nature in the pursuit of the aforementioned business wins and organic growth.
• He the main client contact for designated projects and has developed successful working relationships with clients. He successfully manages the coordination of multicenter pre and post approval studies, and assured the Global Management of multidisciplinary project team (CTA, CRA, Data management, Biostatistics and medical affairs …)
• His scientific Background allows him to be an excellent medical writer for clinical protocol, Investigator brochure, clinical report, patient informed consent, Critical literature review and publications.  He is working with client for protocol development and clinical strategy, site selection, investigators and CRA training on study requirement.
• Achieved regulatory submission, data protection ethics committees and competent authorities (eg. AFSSAPS, MHRA…), safety reporting to EC and CA and DSMB management. He is also responsible of Budget forecasting, budget tracking and reconciliation based on deliverables and Milestones.
• Collaborates with the client to established Study strategy management according to risk analysis and gap analysis.

This candidate seeks an executive level role within an organization that is dynamic and collaborative, a company that will allow him the autonomy to make business decisions in the best interest of the company at a healthcare communication company.