Senior Clinical Project Manager, CRO Services

NMDP • Minneapolis, MN

4d

About The Position

The Senior Clinical Project Manager 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 Senior Clinical Project Manager may directly manage one or more multi-center clinical research studies and/or provide mentoring, training or peer oversight to Clinical Project Managers.

Requirements

• HCT/Cellular therapy clinical trials preferred
• FDA regulations, GCP and industry best practices
• IND and/or IDE submission and reporting processes
• Structure and reporting requirements for grant-funded and industry-sponsored clinical trials
• 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
• Assist with analysis of data and preparation of manuscripts and scientific presentations
• Bachelor’s degree or higher, MPH, MBA or PhD preferred
• At least 4 years of direct clinical program or clinical project management

Nice To Haves

• Experience in adult and pediatric clinical trials
• Experience in reviewing monitoring reports
• Experience in managing vendors and contracts
• Experience in internal and external audits (preparation, participating, responding, closing out)
• Advanced skills using Excel to develop trackers for study management and/or budgets

Responsibilities

• 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
• Provides mentorship, training, and peer oversight, 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
• Ensures 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees