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NMDP · 4 hours ago

Senior Clinical Project Manager, CRO Services

500 N 5th Street, Minneapolis, MN, 55401, US

Full-time

Onsite

Mid, Senior Level

$100K/yr - $120K/yr

4+ years exp

NMDP is a leading organization in clinical research and healthcare services, and they are seeking a Senior Clinical Project Manager to drive clinical trial design and execution. The role involves overseeing multi-center clinical research studies, ensuring compliance with regulations and internal SOPs while managing timelines, budgets, and deliverables.

Health CareHealth DiagnosticsMedicalMedical Device

Comp. & Benefits

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

Qualification

Clinical project managementFDA regulationsGCP complianceHCT/Cellular therapyIND/IDE submissionBudget managementData analysisStakeholder coordinationProcess improvementExcel proficiencyCommunication skillsProblem-solvingMentorship

Required

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

Ability to communicate effectively and interact with senior leadership

Ability to problem-solve in complex situations

Ability to coordinate among disparate stakeholders and organization

Ability to create and maintain project timelines based on goals, objectives, and scope in order to identify tasks, timelines, and required resources for a study

Ability to create, review critically, and provide feedback on quality system documents including Standard Operating Procedures, Work Instructions, and Job Aids

Ability to 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