Project Manager II - Investigator Initiated Clinical Trials/Clinical Research Sponsor Collaboration

The Project Manager II will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/Clinical Research Sponsor Collaboration (CRSC) within the organization. This role involves coordinating all aspects of trial management, ensuring compliance with regulatory requirements, and facilitating collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work closely with investigators, research teams, regulatory bodies, and institutional leadership to ensure the success of each study in the portfolio.

Project Manager II develops and oversees the operational aspects and scope for employee training. Project Manager II is responsible for developing, implementing, and overseeing comprehensive training programs for new staff within the clinical research teams. This role ensures that new employees are equipped with the knowledge, skills, and resources needed to succeed in their roles while adhering to regulatory requirements and organizational standards. The Training role will collaborate with department leaders, senior staff, and other stakeholders to maintain a consistent and high-quality onboarding experience.

IICT/CRSC: Primary Duties and Responsibilities 75-80%

Portfolio Oversight and Management

• Independently manage project teams and collaborations 
• Manage the lifecycle of trials, including start-up, execution, monitoring, and close-out phases.
• Develop, implement, and maintain systems to track progress, milestones, and deliverables across the portfolio.
• Prioritize resources and allocate tasks to ensure timelines and objectives are met.

Regulatory Compliance and Quality Assurance:

• Ensure all trials adhere to Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements (e.g., FDA, IRB, ICH).
• Oversee the preparation and submission of regulatory documents, including protocols, amendments, and safety reports.
• Conduct regular quality assurance checks to identify and mitigate risks.

Financial and Resource Management:

• Develop and manage budgets, ensuring cost-effective use of resources.
• Identify funding opportunities and assist investigators with grant applications and budgeting.
• Monitor financial performance and reconcile expenses to ensure adherence to budgets

Communication and Stakeholder Engagement:

• Serve as the primary point of contact between investigators, research teams, sponsors, and institutional leadership.
• Facilitate regular meetings with stakeholders to provide updates on project status, address challenges, and ensure alignment with organizational goals.
• Promote effective communication and collaboration across all teams.

Team Leadership and Development:

• Supervise and mentor clinical research staff involved, fostering a culture of excellence and accountability.
• Provide training and development opportunities to enhance team performance and competency.
• Delegate responsibilities appropriately, encouraging team members to excel in their roles.
• Resolve conflicts and issues within teams. 

Process Improvement:

• Identify opportunities to improve workflows and standard operating procedures (SOPs) related to study management.
• Develop and implement best practices to enhance efficiency, data quality, and compliance.
• Monitor industry trends and integrate innovative strategies into the program.
• Ensure that team meetings have structure and clear purposes and goals; facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team. 

Staff Training Key Responsibilities 20-25%:

Training Program Development and Implementation:

• Design and implement a structured training curriculum tailored to various roles within the clinical research team, including Clinical Research Coordinators (CRCs), nurses, and other support staff.
• Regularly update training materials to reflect current regulations, organizational policies, and best practices in clinical research.
• Incorporate input from senior leadership, subject matter experts, and team members into training content.

New Staff Onboarding:

• Conduct onboarding s