Clinical Project Manager
333 W. San Carlos Street, Suite 800 San Jose, CA 95110
Bayside Solutions is seeking a Clinical Project Manager to be part of our client’ s team in the South Bay. This is an opportunity to work with a fully integrated Clinical Research Organization.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Project Manager
The Clinical Project Manager may work in-house, 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. Job duties depend on what the client’ s needs are based on their clinical trials.
EDUCATION AND/OR EXPERIENCE
RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience.
- 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 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 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 management, and other functional managers, assess project specific Full Time Equivalent (FTE), assign personnel and corresponding duration; 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, MSProject 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 management, as required).
- Track out-of-scope requests. Communicate with the CRO and Client regarding out-of-scope items.
- 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.
- 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.