Senior Clinical Data Manager

Lightship is a clinical trial site organization delivering on-site, hybrid, and virtual trials through a single, trusted partner. Our expanded reach model places each visit in the most practical setting, increasing access, strengthening enrollment and engagement, and improving representation across diverse communities.

PositionSummary

TheSeniorClinicalDataManagerisresponsibleforleadingalldatamanagementactivitiesacrossoneormoreclinicaltrialsfromstudystart-upthroughdatabaselockandstudycloseout.Thisroleensuresthecollection,validation,integrity,andqualityofclinicaltrialdataincompliancewithprotocolrequirements,ICH-GCPguidelines,regulatorystandards,andcompanySOPs.TheSeniorClinicalDataManagerservesastheprimarydatamanagementleadforassignedstudiesandcollaboratescloselywithClinicalOperations,Biostatistics,MedicalMonitoring,Safety,Sponsors,CROpartners,andtechnologyvendors.

KeyResponsibilities

StudyManagement&Oversight

• DevelopandmaintainDataManagementPlans(DMPs),DataValidationPlans,andstudy-specificdatareviewstrategies.
• Providedatamanagementleadershipduringstudystart-up,conduct,databaselock,andstudycloseoutactivities.
• Serveastheprimarypointofcontactforsponsorandcross-functionaldatamanagementdiscussions.

DatabaseDesign&Development

• Reviewdatabasespecifications,editchecks,derivations,andintegrationrequirements.
• OverseeUserAcceptanceTesting(UAT)andensureallstudyrequirementsaremetpriortogo-live.

DataReview&QualityManagement

• Leadquerymanagementactivitiesandensuretimelyqueryresolution.
• Reviewprotocoldeviations,missingdata,andkeyriskindicatorsimpactingdataquality.
• ePRO/eCOAsystems
• Safetydatabases
• Coordinatewithvendorstoresolvedatadiscrepanciesandintegrationissues.

DatabaseLock&StudyCloseout

• Facilitatedatareviewmeetingsandlockreadinessassessments.
• CoordinatefinaldatatransfertoBiostatisticsandotherstakeholders.
• Supportregulatoryinspections,audits,andsponsorreviews.
• PartnereffectivelywithClinicalOperations,MedicalMonitoring,Safety,Vendors,andSponsors.
• Contributepragmaticdatamanagementsolutionsthatbalancestartupspeed,operationalfeasibility,quality,andbudgetconsiderations.

Additionalresponsibilities,asassigned.

Qualifications

Education

• Bachelor'sdegreeinLifeSciences,ClinicalResearch,HealthInformatics,Biostatistics,ComputerScience,orrelatedfieldrequired.
• Advanceddegreepreferred.

Experience

• ExperienceleadingdatamanagementactivitiesforPhaseI-IVclinicaltrials.
• Experiencewithdecentralized,hybrid,ordigitalclinicaltrialspreferred.
• Priorsponsor-facingleadershipexperiencestronglypreferred.

TechnicalSkills

• ProficiencywithEDCsystemssuchasMedrio,MedidataRave,VeevaVaultCDMS,OracleInForm,orequivalent.
• Experiencewithexternaldataintegrationsandreconciliationprocesses.
• Experienceparticipatinginstudystartupactivities,includingprotocolreview,datacollectionstrategydevelopment,andEDCimplementation
• Knowledgeofclinicaltrialregulations,includingICH-GCP,FDA,EMA,andapplicableglobalrequirements.
• Excellentanalyticalandproblem-solvingabilities.
• Exceptionalattentiontodetailandcommitmenttodataquality.
• Strongcommunicationandstakeholdermanagementskills.
• Abilitytoworkindependentlyinafast-pacedenvironment.

PreferredExperienceforDecentralizedClinicalTrials

• Experienceoverseeingdatafromremoteandvirtualtrialtechnologies.
• Experiencewithdiagnostic-deviceordiagnostic-assayclinicalstudiespreferred.
• Familiaritywithparticipant-centricdatacollectionmethodologies.

SuccessMeasures

• Successfulmanagementofmultipleconcurrentstudieswhilemaintainingqualitystandards.