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POSITION SUMMARY:

The Manager, Clinical Project Management drives all aspects of clinical trial design and execution. This role oversees design, start-up, execution, and close-out of one or more multi-center clinical research studies, ensuring that studies are run in accordance with regulations and internal SOPs.

The Manager, Clinical Project Management, may directly manage one or more multi-center clinical research studies or provide oversight to the Clinical Project Manager (CPM) who manage ones or more studies. The Manager, Clinical Project Management mentors' junior employees and may directly manage other clinical research roles which include: Clinical Project Manager(s) and Clinical Trial Assistant(s). This is a remote position (US). #LI-Remote

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ACCOUNTABILITIES:

Coordinates, manages, and performs activities related to clinical research projects:

• Manages study timeline, budget, and deliverables
• Works cross-functionally to ensure all aspects of clinical studies are executed in accordance with ICH/GCP, regulations and SOPs
• May oversee new study budget creation and tracking of ongoing finances
• Uses operational and therapeutic expertise to optimize trial design. Drives development and creation of study-specific documents and processes, including but not limited to protocol, informed consent, case report forms, investigator brochure and study plans.
• Oversees data intake and review to ensure early detection of data trends
• Educates self in new therapeutic areas, pursues education opportunities and seeks at all times to bridge gaps in knowledge
• Creates and/or streamlines processes to make an impact on the group portfolio of studies
• Able to problem-solve complex issues
• Works with finance and contracts to drive vendor agreements and oversight
• Creates metrics and audience-driven reporting to deliver key messaging for study outcomes and compliance
• Models' professional demeanor for external stakeholders through pristine communication, knowledge of company and therapeutic area, and expertise in clinical research
• Nurtures key internal and external relationships to further NMDP/CIBMTR goals and patient outcomes

Leadership:

• Provides oversight and leadership to junior team members, including new and current Clinical Project Managers, and escalates issues when appropriate
• Demonstrates senior-level capabilities of risk management and mitigation by anticipating clinical study issues and proactively implementing strategies to contain risks
• Creates and/or streamlines processes to make an impact on study portfolio
• Liaises with operational leaders to identify efficiencies, manage team priorities, and foster clear communication and expectations
• Oversees staffing and workflow to align with project timelines and goals
• Ensure staff are executing work in compliance to ICH/GCP guidelines and in accordance with internal SOPs
• Drives staff efficiency, productivity, and engagement by understanding strengths, weakness, and drivers

REQUIRED QUALIFICATIONS:

Knowledge of:

• HCT/Cellular therapy clinical trials preferred
• FDA regulations, GCP and industry best practices
• IND and/or IDE submission process
• Structure and reporting requirements for grant-funded and industry-sponsored clinical trials

Ability to:

• Exemplify our NMDP Standards
• Communicate effectively and interact with senior leadership
• Problem-solve in complex situations
• Coordinate among disparate stakeholders and organization
• Create and maintain project timelines based on goals, objectives, and scope in order to identify tasks, timelines, and required resources for a study
• Create, review critically, and provide feedback on quality system documents including Standard Operating Procedures, Work Instructions, and Job Aids

Education and/or Experience:

• Bachelor's degree or higher, MPH, MBA or PhD preferred
• 5 years of direct clinical program or clinical project management

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Experience in adult and pediatric clinical trials
• Experience in reviewing monitoring reports

DEI COMMITMENT:

As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.

BENEFITS:
NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information

Additional Information

• Number of Openings: 1
• Pay Basis: Yearly
• Schedule: Full-time
• Driver Policy: No
• Job Family: Business Services
• Career Category: Established Leader / Established Professional
• Career Level: 7