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Clinical Program Manager
| Details |
Country: USA
Location: CA Emeryville
Total applied: 41
Relevant Work Experience: 5+ to 7 Years
Career Level: Experienced (Non-Manager)
Education Level: Bachelor's Degree
Job Type: Employee
Job Status: Full Time
Salary: From 110,000.00 to 120,000.00 USD per year
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Clinical Program Manager
Newly created position with this rapidly expanding privately held Biotech (drug deliver studies). Outstanding growth opportunity. Must enjoy fast paced,change oriented environment.
Basic Qualifications:
At least 5 years experience at CRA III/Senior CRA level in the industrial setting and at least 2 years of project management experience managing Phase III registration trials
Experienced in Phase II trials
Experienced in planning and executing NDA trials
Experienced in generating study time line, milestone and tracking study progress
Proficient in generating CRF, study reference manual, CRF completion guideline, Safety Plan, Monitoring Plan, and other study related documents
Proficient in clinical SOP generation
Planned, conducted and successfully managed Investigator Meetings
Experienced in all aspects of clinical operations and trial executions
Experienced or assisted in protocol and Investigator Boucher generation
Experienced in reviewing data management plan
Experienced in reviewing and sign off clinical trial monitoring reports
Experienced in managing and supporting in-house and field CRAs
Successful track record in initiating and completing clinical trials
Excellent understanding of essential documents for trial opening and NDA submissions
Experienced in IRB submissions and addressing IRB concerns
Experienced in addressing protocol and enrollment issues and trouble shooting site issues
Experienced in contract and budget negotiation
Experienced in generating and maintaining study master file and site regulatory binders
Experienced in managing CROs, central labs and outside consultants
Detailed oriented
Good written and oral communication skills
Excellent interpersonal skills
Highly motivated and positive attitude
Experienced in mentoring and managing CRAs
In depth understanding of Good Clinical Practice, ICH guideline and IRB regulations
Nursing degree, BS or MS in life science
20% travel required
Other Qualifications:
Experienced in IND and NDA submissions
Experienced in CNS and/or sleep trials
Experienced in trials for pain management
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Biotechnology and Pharmaceutical 
