Clinical Project Manager-Ophthalmology & Oncology
Title: Clinical Project Manager- Ophthalmology and Oncology study experience
Location: Remote, home-based anywhere in US
Start Date: ASAP
Perm/salaried/direct with CRO client
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 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 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, MSProject tools)
- Monitor and manage the project's progress, identify hurdles and manage changes, via frequent interactions with Team, other Functional Groups, and Sponsor.
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.
- 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
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