Here's another Clinical Trial Manager job. It says 3 positions open. Getting ready for more trials?
Clinical Trial Manager/Sr. Manager
Date: Posted 25-Sep-2014, Closing 24-Dec-2014 (PST)
Department: PPHM - Clinical Research
Location: Tustin, CA
Employment Type: Full Time
Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical trials management expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.
SUMMARY
To support our clinical progress, we currently have three Clinical Trial Manager openings at either the manager or senior manager level. This position develops strategic clinical approaches for the overall clinical development of a biotechnology or pharmaceutical product, domestically and/or internationally, by performing the following duties personally or in collaboration with clinical team members:
ESSENTIAL DUTIES AND RESPONSIBILITIES
Protocol design and implementation
Manage study start up activities
Participation in site training
Site management and visits
Vendor selection and management (CRO, central lab, etc.)
Ensure integrity of clinical data
Ensure adherence to regulatory and company guidelines
Evaluation of clinical data
Assist with regulatory filings
Necessary administrative activities as part of the project team
Safety reporting
Assurance of adherence to regulatory guidelines and SOP's
QUALIFICATIONS
A Bachelor's degree (BA or BS) in life sciences from a four-year college or university is required for the Clinical Trial Manager level. An advanced degree, i.e. Master's degree is preferred for the Sr. Clinical Trial Manager level.
At least 5+ years of pharmaceutical industry experience is required for the Clinical Trial Manager role while 8+ years is required for the Sr. Clinical Trial Manager role. Oncology therapeutic experience including solid tumor studies is preferred. Extensive experience in clinical/regulatory monitoring is essential. Must have a background in multicenter clinical trials with appropriate knowledge of GCPs and regulations. Primary management of at least one multicenter study and other Phase 1-3 studies using CROs is also required. Experience drafting or reviewing technical documents such as protocols, clinical study reports, clinical sections of IND/NDAs, and safety reports is needed. In addition, knowledge of clinical study guidelines including FDA, ICH and GCP is essential. Familiarity with the drug development process is required.
OTHER REQUIREMENTS
Occasional overnight travel by land and/or air may be required to attend meetings, out of state site visits, conferences, etc.
RELOCATION AVAILABLE
Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.
