Career Opportunity Postings

For posting information, email careerops at projmgr dot org

Mon, 19 Jul 2010

Clinical Project Manager - Recuiter

Location: Sunnyvale, California

My client is a clinical CRO with an outstanding reputation for conducting high quality clinical trials (both US and Internationally). What makes this position particularly attractive is that this CRO has a corporate culture that is similar to a small biotechnology company. The work environment is entrepreneurial, energetic, challenging and fun. The high employee retention rate of over 90% in the company reflects their commitment to clear communication and comprehensive support.

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Position Description

The Clinical Project Manager may work in-house or at a client’s office, or be regionally based. The primary responsibilities of the Clinical Project Manager are to provide overall coordination and management of a clinical trial, in conjunction with the clinical team, and to serve as the primary contact with the Sponsor and clinical team. Depending on the Scope of Work defined by the Client, this individual may be involved in some but not all of the functions listed below.

• Takes a lead role in a study or series of studies, and may provide strategic and tactical planning, organization, direction and tracking for completion of a study or series of studies within a project (including oversight of clinical project timelines, reports, budgets, monitoring, site management, clinical supplies and data collection)
• Facilitate and foster positive and productive communication between Sponsor, Team and other functional groups. Develop and implement a project-specific Communication Plan, in agreement with the Sponsor
• Ensure timely and accurate communication of all aspects of the project to the Team, including Sponsor requirements, instructions and changes
• Communicate with senior management on project progress, resource needs, Sponsor issues, and team member performance
• With Sponsor input, and based on project requirements, carry out project planning; document plans in writing for distribution to the Team, Sponsor and senior management, as appropriate. Monitor and update Plans throughout the life of the project.
• Quality parameters – identify SOPs, Guidelines, Templates to be used and provide to Team members.
• Develop a Monitoring Plan and obtain sponsor approval before site visits occur
• Resource Plan – with input from senior management, and other functional managers, assess how many, who, when and for how long; assess site assignment/workload by region. Monitor and adjust the resource plan based on project or team member changes
• Develop contingency plan(s), with Team and Sponsor input, for potential hurdles that would delay the project’s progress
• Assess training needs of team members on therapeutic area, protocol, special procedures/skills; develop training plan for new team members added later
• Develop processes to support the Team’s activities (i.e. flow of site visit reports and other documents for review and submission, Travel Calendar, Teleconference call-in process, etc.)
• Identify detailed work activities and develop timelines with Team and other functional group input and Sponsor approval (Excel, MS Project tools)
• Monitor and manage the project’s progress, identify hurdles and manage changes, via frequent interactions with Team, other Functional Groups, and Sponsor.
• Schedule regular team meetings/teleconferences to track progress and status of Team’s activities and to obtain Sponsor direction, changes, and decisions
• Monitor, manage and adjust timelines and milestones with input from Team, other functional groups and Sponsor; re-assess critical path and communicate to all
• Track performance metrics of Team
• Provide informal and formal status reports to Sponsor, Team, (and senior management, as required)
• Track out-of-scope requests. Communicate with senior management and Client regarding out-of-scope items
• Monitor and adjust the resource plan based on project or team member changes
• Manage study billing/budget versus proposed budget, as appropriate
• Oversee activities and deliverables of outside vendors, as requested. Ensure communication occurs between outside vendors and Team and Sponsor
• Manage and motivate team members, and monitor and guide their progress.
• Attend and/or present at Investigator Meetings and/or Monitor Training Workshops
• Develop and/or review study documents (i.e. protocol, Investigator Brochure, ICF, CRFs, Operations manual, study aids, site budget, etc.)
• Assist Sponsor and team members in problem-solving of study and site specific issues
• Review CRA-generated documents (i.e. site visit reports, letters, telephone reports, as needed)
• Carry out Potential Investigator screening and selection
• Carry out Collection/Review of site regulatory documentation

Requirements

• RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 5+ years CRA experience or 3 years CRA experience and 3 years directly related experience in health care industry
• At least two years experience as a clinical project manager
• Outstanding interpersonal, oral and written communication skills
• Proven effectiveness as a team leader
• Prior experience successfully managing multifaceted studies from inception through implementation and completion
• Computer proficiency in Microsoft Word, Excel, and PowerPoint are required. Experience with MS Project a plus
• This position requires the ability to multitask, detail orientation, leadership qualities, professionalism, and strong work ethic

If you have recommendations or are interested in applying, please contact:

Toby Freedman, Ph.D., President at Synapsis Search
Toby@synapsissearch.com
Business and R&D recruiting services in the life sciences
And Author, Career Opportunities in Biotechnology and Drug Development,
www.careersbiotech.com
650-227-0132