Senior Clinical Data Manager

Lightship; Durham (NC); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Lightship seeks a Senior Clinical Data Manager to lead data management activities across one or more trials from startup through database lock and closeout. You will ensure data integrity, quality, and regulatory compliance while collaborating with cross-functional teams.

Responsibilities include developing DMPs, leading UAT, coordinating with vendors, and supporting inspections. A strong background in EDMS and decentralized trials is preferred.

Formación

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• Experience leading data management activities for Phase I–IV trials.
• Experience with decentralized, hybrid, or digital clinical trials preferred.
• Knowledge of ICH-GCP and regulatory requirements.

Responsabilidades

• Lead data management activities across one or more trials from startup through database lock and study closeout.
• Develop and maintain Data Management Plans (DMPs), data validation plans, and study-specific data review strategies.
• Coordinate with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Sponsors, CRO partners, and technology vendors.
• Oversee UAT and ensure all study requirements are met prior to go-live.
• Support regulatory inspections, audits, and sponsor reviews.

Conocimientos

Data leadership

Stakeholder management

Analytical thinking

Independent work

Educación

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Herramientas

Medrio

Medidata Rave

Veeva Vault CDMS

Oracle InForm

Descripción del empleo

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.