Senior Clinical Project Manager, CRO Services
NMDP
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- 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
Requirements
- Bachelor's degree or higher, MPH, MBA or PhD preferred
- At least 4 years of direct clinical program or clinical project management
- 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
- 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
- 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
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical project managementclinical trialsdata analysisbudget managementprotocol developmentcase report formsIND submissionIDE submissionquality system documentsExcel
Soft skills
problem-solvingcommunicationmentorshiprelationship managementrisk managementteam managementorganizational skillscross-functional collaborationtrainingleadership
Certifications
Bachelor's degreeMPHMBAPhD