Note: The job is a remote job and is open to candidates in USA. Bayside Solutions is hiring a Clinical Project Manager to lead clinical study operations and provide strategic and tactical direction throughout the study lifecycle. The role oversees project timelines, budgets, monitoring, site and vendor management, clinical supplies, data collection, team leadership, risk management, and regulatory compliance.
Responsibilities
- Facilitate and foster positive, productive, and timely communication between the sponsor, the study team, and other functional groups
- Manage and motivate the study team while serving as a mentor; mentorship may include identifying the skills of the clinical team members and assisting with further professional development
- Provide proper financial oversight of study budget, including out-of-scope tracking, in conjunction with the Client Manager (CM) and our Finance Department
- Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals
- Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e., monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)
- Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans
- Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project
- Actively manage and track study risks (with team and sponsor input for potential obstacles that would delay the project's progress while appropriately escalating issues
- Assess the training needs of team members in the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans
- Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their roles
- Monitor and manage the project's progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess the critical path for study progress and adjust timelines as needed
- Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and the sponsor
Skills
- RN or Bachelor's and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, or training, and previous CRA experience
- 4-5 years of 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
- Outstanding organizational and time management skills
- Experience managing projects in a virtual environment
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Proficiency in Microsoft Word, Excel, and PowerPoint is required
- Experience with MS Project and OneNote is a plus
Benefits
- Remote Role - Within CA
- Mentorship and assistance with further professional development for clinical team members
Company Overview