NMDP

Compensation

Full Description

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 REQUIRED QUALIFICATIONS: Knowledge of: • 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 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 • Assist with analysis of data and preparation of manuscripts and scientific presentations Education and/or Experience: • Bachelor’s degree or higher, MPH, MBA or PhD preferred • At least 4 years of direct clinical program or clinical project management PREFERRED QUALIFICATIONS: • 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 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