Clinical Program Manager

Calderome

Location: So. San Francisco, California-San Francisco 94080
Posted on: 2/14/2008 6:06:33 PM
Postion type: Full time
Job Code: BAClOps0208
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
We are seeking qualified applicants for the position of Clinical Program Manager to become a member of our founding team at our headquarters in South San Francisco. In this hands-on position you will have primary responsibility for managing one or more clinical trials working within the Clinical Operations Team. In this position you will
• Assist in managing all aspects of clinical studies to ensure completion in compliance with SOPs and FDA and all global diagnostic regulations
• Effectively develop and manage study timelines and budgets by gathering relevant factors from multiple disciplines
• Drive efficient completion of multiple projects through focused efforts to process multiple project aspects in parallel
• Lead CRO and vendor selection process for assigned studies; manage CRO and vendor relationships and work
• Establish and maintain productive and collegial relationships with investigators and coordinators through frequent contact and attention
• Participate in the design and development of study protocols
• Actively manage sample accrual required for both discovery/scientific collaborations as well as clinical trials aimed at product approvals
• Design study documents including, but not limited to clinical protocols, case report forms, site study procedure manuals and project tools, monitoring plans and informed consents
• Provide guidance, clinical trial management expertise and direction to contract CRAs
• Evaluate, manage and facilitate the flow of clinical data; ensure milestones and timelines are met.
• Establish mechanism to validate data collection requirements of the trial
• Assist in preparation of clinical study reports, annual reports
• Contribute to the development of the Clinical Department SOPs

REQUIREMENTS:
The ideal candidate will have

• At least a Bachelors degree in a scientific discipline or health-related field; advanced degree a plus
• Minimum 5 years of relevant experience as well as experience as a project team leader within clinical research
• Experience establishing IRB’s for sample collection, knowledge of HIPAA requirements, and experience gathering clinical sample data
• Clinical trials experience with diagnostics preferred; therapeutic experience a plus
• Demonstrated working knowledge of CGP guidelines and FDA regulations through all phases of clinical development
• Experience with ex-US clinical studies desirable
• Demonstrable track record of leadership and management experience
• Expert knowledge of clinical studies

Other skills and attributes

• Accuracy and attention to detail
• Excellent problem solving skills; demonstrated strength in tact and diplomacy working with study coordinators and investigators
• Ability to work independently; exercise good judgment
• Excellent teamwork and collaboration skills
• Effective process and project management skills
• Outstanding verbal and written communication skills; presentation skills a plus
• Flexibility and agility; ability to wear several hats and process multiple tasks simultaneously

Computer skills

Proficiency in MS Office Suite including Word, Excel, PowerPoint, Outlook and Project
Label