Responsible for planning, executing, managing and monitoring complex clinical research projects.
ESSENTIAL FUNCTIONS PERFORMED
- Develops and oversees study operational plans.
- Contributes in external vendor qualifications and selection related to clinical trials.
- Manage CRO and other external vendors supporting clinical studies.
- Participates in the design, planning and execution of multiple phases of clinical trials to GCP and IHC standards.
- Oversees and ensures adherence to GCP and ICH guidelines, regulatory requirements, SOPs, and protocols; takes ownership for data completion and accuracy.
- Contributes to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.
- Contributes to study team for trial start-up, conduct and close-out activities according to industry and corporate standards.
- Participate in study data review and assists with patient outcome narrative writing and other data review activities as assigned.
- Oversees and participates in initiation, training and monitoring activities at clinical trial sites.
- Contributes to creation of study documentation including clinical protocols, study tools, informed consent, investigator brochures, and clinical study reports.
- May lead the work of Clinical Project Managers by training, mentoring, supervising work projects, etc.
- Performs other duties and tasks, as required.
SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelor's Degree in science discipline such as Biology, Chemistry, etc. or Life Science, etc.
- Eight years of experience in the medical device, pharmaceutical drug development, biotech or CRO industries.
- Excellent knowledge of ICH/GCP including relevant Guidance documents from FDA, ICH, and EMEA, etc.
- Experience in clinical trial site monitoring.
- Experience managing outside vendors such as CRO's, consultants, and other subcontractors.
- Demonstrated effective verbal and written communication skills; fosters smooth flow of timely and relevant information.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
- Strong organizational skills and the ability to be self-motivated and be detailed oriented.
- Experience interfacing with multiple vendors/contractors.
- Proven ability to handle multiple projects and changing priorities.
- Must be results-driven and exhibit a sense of responsibility and outcome ownership.
- Ability to travel to clinical sites, domestic and foreign, up to 25%.