Ceo Owner resume example with 20+ years of experience
A Clinical Research Study Management Professional with 10+ years servicing the Pharmaceutical and Biotechnology industries. Experienced in Phase II, III and IV Clinical Trial Designs across therapeutic areas (Cardiovascular, Oncology, Endocrinology, CNS, GU, Respiratory, Musculoskeletal, Gastrointestinal).
Specializing in large Phase III-IV Clinical Trial (4000+ subjects; 300+ sites). Extensive experience managing large project teams (30+) and study sites (300+). Highly skilled leader in Clinical Operations, Project/Study Management, and Data Management. Also experienced in Business Development services such as staff and subject recruitment and contract negotiations and management.
Looking for long contract opportunities (6 to 12 months) or contract to permanent in Remote based Project Management.
Completed course in Organizational Behavior.
- Ability to build solid teams and provide mentoring and training
- Proven ability to manage People, Portfolio, Projects, Protocol, Data
- In Depth Knowledge of project management methods guidelines
- Excellent contracts management and negotiation skills
- Ability to manage multiple projects efficiently
- Immense Knowledge of study monitoring processes
- Proficient use of MS Project, MS Office suite and iWorks
- Extensive understanding of good clinical practice
- Solid budget and contracts management skills
- Solid understanding of ICH/GCP
Baltimore, MD, 10/2007 - Current
- Started own small consulting company offering short term contracts to various Clinical Research Projects for major Pharmaceutical and Biotechnology, and niche start-up companies.
- Managed all features of business including client services, contract negotiations and operations as well as resourcing self to perform contracted clinical research services as follows: Clinical Trial Management/Project Management, Recruitment Management, Sales support and Marketing and Subject Matter Expert.
San Angelo, TX, 01/2005 - 2007
- Provided various contract services to several Research Pharmaceutical Services (RPS) clients.
- Directed Clinical Operations (SE Region) for major contract with supervisory responsibility of 16+ direct reports across several therapeutic areas.
- Pro- vided Senior Clinical Project Management services for various project teams.
- Assisted Director with re- structuring of Clinical Trial Operations resulting in her promotion.
- Assisted Associate Director with resource management including, the recruiting, on-boarding, mentoring and exiting of staff.
- Facilitated restructuring and process improvement of Phase I unit including interview and recruiting new hires and facilitating the contract negotiations of exiting staff.
Houston, TX, 10/2001 - 2005
- Initially hired as a Senior Project Manager/Clinical Trial Manager then promoted to Project Director.
- Responsible for direct supervision, mentoring and training of assigned Senior Project Managers, Project team and line management of Functional leads.
- Provided direct client services and contract management services for preferred provider.
- Designed and customized client funded project management tools.
- Assisted with RFP and RFI of new business.
- Managed Project Timelines, budgets, tracked change orders and co-managed client's internal project team.
- Successfully managed CRESTOR trial, a large PhIIIb-IV clinical trial with 4000+ at 125+ centers from start to finish.
- Also managed clinical trials for marketed drugs: Pulmozyme, VIOXX, OXYTIN, VIAGRA, as well as other NDA's.
Gainesville, FL, 02/1991 - 10/2001
- Spent 10+ years growing career in clinical research and drug development gaining increased responsibility with each corporate and process change.
- Initially hired to provide contracted Data Coordinator serv- ices generating/resolving data discrepancies.
- Progressed to designing project database and scribed logic for relational database queries.
- Lead several data coordinating teams resulting in promotion to Data Man- ager, Also participated in process improvement initiatives and cross-trained as Clinical Research Associ- ate (CRA) and field monitoring.
- Developed site management skills and conducted all types of onsite visits.
- Then, home based as Regional CRA for US based research centers in SouthEast region.
- Progressing to Clinical Trail Management and Promoted to Project Manager/Clinical Trial Manager with responsibility for supervising, training and mentoring direct reports and line management responsibilities for project teams.
City, STATE, 01/1989 - 02/1991
- Responsible for patient recruitment, data collection and analysis of Phase I - Phase III Pediatric studies in Leukemia, Lymphoma, Solid Tumors, and Germ cell tumors under the direct supervision of Principal Investigator.
- Created, managed, and maintained a computerized database of patient records compiled from medical charts.
- Responsible for all duties associated with initiation/completion of clinical trials both sponsored and internal studies.
- Resolved data issues and generated final study reports and patient summaries for Sponsors and for presentations at ASCO meeting.
- Pivotal accomplishment was successful completion of on-site "not for cause" FDA audit.
Budgets * Consulting * Contract management & negotiations * Data collection * Database designing, *Functional, logic, Director/ Management skills * Marketing * Mentoring Organizational, presentations * Process improvement * Project Management * Recruitment
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Resume Overview
School Attended
- Fordham Fordham College, Rose Hill Campus
- University of Phoenix
Job Titles Held:
- CEO/Owner
- Associate Director
- Project Director
- Senior Project Manager
- Research Assistant
Degrees
- Bachelors of Science
- MBA
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