North Highlands CA 95660
Seeking work as Clinical Trial Manager with company to advance my skills and career in this field.
Highlights of Qualifications:
- Experience in contract negotiation and clinical trials for biotech environment
- Operational knowledge of database
- Exceptional knowledge of GCP requirements
- Ability to analyze data and prepare summaries
- Ability to maintain confidentiality of information
- Excellent communication and interpersonal skills
- Skilled to resolve all issues
- Proficient in managing multiple projects
Clinical Trial Manager
Synteract Inc., Toledo, OH
October 2008 – Present
- Planned budget and resources for clinical study programs.
- Administered clinical operational plan and incorporate scientific plans.
- Designed study documents and determined appropriate protocols.
- Ensure compliance to all manufacturing regulations and guidelines.
- Supervised efficient working of clinical and operational staff.
- Prepared clinical budget and designed clinical trials.
- Developed business strategies and designed study plans.
- Reviewed personnel performance for all operations.
Clinical Trial Specialist
Ockham Development Group Inc, Toledo, OH
August 2003 – September 2008
- Coordinated with sponsor and site for contract negotiation.
- Evaluated required site regulatory documents.
- Managed regular tracking of projects in compliance with timeframe.
- Participated in operations meetings and provided training.
- Maintained knowledge on all ICH guidelines and clinical practices.
Clinical Trial Assistant
Sunrise Systems Inc, Toledo, OH
May 1998 – July 2003
- Performed various study associated meetings.
- Prepared required presentations and study protocols.
- Managed study materials and assisted in shipment.
- Maintained record of all invoices and payments.
- Facilitated required documents for clinical trials.
Bachelor’s Degree in Healthcare Administration
El Camino College, Torrance, CA