Clinical Project Manager

Bayside Solutions; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Bayside Solutions seeks an experienced Clinical Project Manager to lead complex study operations, aligning timelines, budgets, and deliverables with sponsor expectations.

You will mentor teams, manage vendor relationships, and ensure GCP and regulatory compliance while coordinating cross-functional stakeholders in a virtual environment. An advanced degree or equivalent CRA experience is preferred.

Qualifications

• 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 in clinical project management.
• 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

Responsibilities

• Lead and coordinate study timelines, budgets, monitoring, site and vendor management.
• Foster effective communication between sponsor, study team, and functional groups.
• Mentor study team and support professional development.
• Provide financial oversight of study budgets and out-of-scope tracking.
• Develop and maintain project management plans and risk mitigation strategies.
• Ensure compliance with GCP, SOPs, regulatory requirements, and plans.
• Oversee vendor activities and sponsor communications.

Skills

Team leadership

Communication

Mentoring

Time management

Organizational skills

Virtual environment experience

CRA experience

Education

RN

Bachelor's in biological sciences or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

MS Project

OneNote

Job description

Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s), including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection.

Duties and 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.

Requirements and Qualifications:

• 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

Desired Skills and Experience

Clinical Project Management, Clinical Trial Operations, Study Planning, Study Start-Up Through Closeout, Clinical Study Oversight, Project Timelines, Critical Path Management, Study Budgets, Financial Oversight, Out-of-Scope Tracking, Resource Planning, Risk Management, Issue Escalation, Sponsor Management, Stakeholder Communication, Cross-Functional Team Leadership, Team Mentoring, Training Plans, Site Management, Vendor Management, CRA Experience, Clinical Monitoring, Clinical Supplies, Clinical Data Collection, Project Plans, Monitoring Plans, Communication Plans, eTMF Plans, GCP, SOP Compliance, Regulatory Compliance, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Microsoft OneNote, Virtual Project Management, Organizational Skills, Time Management, Written and Verbal Communication