Director, Clinical Research Solutions - Rockville

Job summary

At Digital Infuzion we believe that by equipping researchers with rapid insights and providers with tailored on demand data we can help people lead better healthier lives We harness innovative health IT solutions and advanced bioinformatics to make meaningful impacts in patient care If you are passionate about leveraging technology to advance healthcare and thrive in a collaborative mission driven environment this may be the opportunity for you Position Summary The Project Director Clinical Research Solutions serves as the senior leader responsible for the successful execution of a strategic clinical research support program for the National Institute on Aging NIA This role provides scientific operational and programmatic leadership for a multidisciplinary team delivering comprehensive project management regulatory oversight data and safety monitoring coordination analytics and recruitment support for Alzheimer s disease and aging related studies The Project Director drives strategic alignment between NIA s research mission and Digital Infuzion s delivery excellence driving quality compliance innovation across all clinical research support functions This includes oversight of the Data amp Safety Monitoring Board DSMB amp Observational Study Monitoring Board OSMB operations stewardship of CROMS Clinical Research Operations amp Management System data integrity amp advancement of inclusive recruitment strategies for underrepresented populations in clinical research This leadership role directly contributes to NIA s mission to improve the health amp well being of older adults through innovative inclusive amp high quality clinical research Reporting directly to the Vice President of Operations Client Delivery Services the Project Director collaborates with Practice Area Leads Technical Operations leadership amp cross functional teams to ensure excellence in execution financial performance client satisfaction while driving innovation across the health-research ecosystem Key Responsibilities Program Amp Project Leadership Serve as primary contact amp strategic partner between sponsor organization Leverage scientific or clinical subject matter expertise strengthen decision making enhance delivery quality reinforce Digital Infuzion status trusted research Amp health innovation partner Build strategic partnerships across teams stakeholders drive alignment integrated delivery Trusted advisor NIA leadership known proactive engagement clear communication consistent delivery Strategic value positioning Digital Infuzion long term partner advancing Institute s mission Lead project planning execution delivery ensuring adherence standards procedures Establish communicate manage customer expectations transparency accountability Drives financial stewardship operational efficiency proactively managing budgets contracts scope alignment Drive proactive risk identification issue management resolution Champions culture compliance quality ensuring activities align SOPs ICH GCP regulatory contract specific requirements Leads multidisciplinary team spanning clinical operations data management analytics functions Leverages coaching recognition professional development sustain high performing mission aligned team Portfolio Oversight Amp Organizational Leadership Provide enterprise level oversight portfolio clinicallresearchdata driven initiatives ensuring alignment organizational strategy client priorities Reinforces stakeholder trust translating complex program performance clear actionable insights demonstrated results Lead governance performance efforts driving standardization transparency best practices projects Empowers develops emerging leaders fostering culture ownership accountability continuous learning drives delivery excellence client satisfaction Partner senior leadership translate portfolio insights Strategic direction operational priorities Serve thought leader internal SME contributing white papers Strategic proposals business development initiatives Identify advance opportunities Innovation growth crossprogram synergy within ClinicallResearchSolutions portfolio Applies digitalhealthinnovation AI datadriven strategies enhance clinicaTrials visibility participant engagement Leverages coaching recognition professional development sustainhighperformingmissionalignedteam Continuous ImprovementAmpInnovation Support adoption AInnovativeanalytics tools enhancprojectvisibilityperformanceinsights Champion processinnovation improvementinitiativesthat elevate performancequalityscalability Drives InnovationinprojectampProgrammanagementthroughdigitaltransformationautomationdatadriveninsight Champion knowledgesharingcontinuallearningacrossteams Requirements Master Doctoral degreehealthlifes sciences field10 + yearsexperiencemanagingcomplexlarge-scaleprojectsprograms federalgovernmenthealthcarelifesciences sectors Proven ability oversee multiplerelatedinitiatives timecostquality Strongfinancialacumen experience managingcontractsbudgetsscopealignment Exceptionalpresentationcommunication interpersonal skills Stronganalyticalproblem-solvingstrategicthinking abilities Abilitytranslatecomplexscientificoperationalprocessesintoactionabledeliveryplans QualificationsAndExperience DoctoraldegreePhDDrPHMDPharmDDScacceptablealternative MasterMPHMSMHAor MBAwithsignificantclinicalresearchmanagementexperience 10–12 yearsexperiencelineworkingclinicallyadministeredoperationsprogrammanagement PMPcertificationorequivalentproject/programmanagementcredential Demonstratedexperience supportingormanagingdatasafetyboardsDSMB or similaroversighcommittee strongunderstandingofclinicaTrialLifecycleStudyOperations

Job description