Senior Clinical Project Manager, CRO Services

NMDP•Minneapolis, MN

About The Position

POSITION SUMMARY: 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. 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 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

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
Creates and/or streamlines processes to make an impact on the group portfolio of studies
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