Please apply online using a laptop or desktop computer. POSITION SUMMARY : The Manager, Clinical Project Management 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 Manager, Clinical Project Management, may directly manage one or more multi-center clinical research studies or provide oversight to the Clinical Project Manager (CPM) who manage ones or more studies.
The Manager, Clinical Project Management mentors' junior employees and may directly manage other clinical research roles which include : Clinical Project Manager(s) and Clinical Trial Assistant(s).
This is a remote position (US).
LI-Remote Check out our video Saving Lives : It's the Best Job Ever 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 trendsEducates self in new therapeutic areas, pursues education opportunities and seeks at all times to bridge gaps in knowledgeCreates and / or streamlines processes to make an impact on the group portfolio of studiesAble to problem-solve complex issuesWorks with finance and contracts to drive vendor agreements and oversightCreates metrics and audience-driven reporting to deliver key messaging for study outcomes and complianceModels' professional demeanor for external stakeholders through pristine communication, knowledge of company and therapeutic area, and expertise in clinical researchNurtures key internal and external relationships to further NMDP / CIBMTR goals and patient outcomes Leadership :Provides oversight and leadership to junior team members, including new and current Clinical Project Managers, and escalates issues when appropriateDemonstrates senior-level capabilities of risk management and mitigation by anticipating clinical study issues and proactively implementing strategies to contain risksCreates and / or streamlines processes to make an impact on study portfolioLiaises with operational leaders to identify efficiencies, manage team priorities, and foster clear communication and expectationsOversees staffing and workflow to align with project timelines and goalsEnsure staff are executing work in compliance to ICH / GCP guidelines and in accordance with internal SOPsDrives staff efficiency, productivity, and engagement by understanding strengths, weakness, and drivers REQUIRED QUALIFICATIONS : Knowledge of :HCT / Cellular therapy clinical trials preferredFDA regulations, GCP and industry best practicesIND and / or IDE submission processStructure and reporting requirements for grant-funded and industry-sponsored clinical trials Ability to :Exemplify our NMDP StandardsCommunicate effectively and interact with senior leadershipProblem-solve in complex situationsCoordinate among disparate stakeholders and organizationCreate and maintain project timelines based on goals, objectives, and scope in order to identify tasks, timelines, and required resources for a studyCreate, review critically, and provide feedback on quality system documents including Standard Operating Procedures, Work Instructions, and Job Aids Education and / or Experience :Bachelor's degree or higher, MPH, MBA or PhD preferred5 years of direct clinical program or clinical project management PREFERRED QUALIFICATIONS : (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)Experience in adult and pediatric clinical trialsExperience in reviewing monitoring reports DEI COMMITMENT : As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP.We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender.
Everyone is welcome and supported in their development at all stages in their journey with us. 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 Additional Information
Number of Openings : 1Pay Basis : YearlySchedule : Full-timeDriver Policy : NoJob Family : Business ServicesCareer Category : Established Leader / Established ProfessionalCareer Level : 7
