[Remote] Senior Clinical Data Manager

Note: The job is a remote job and is open to candidates in USA. eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. As a Senior Clinical Data Manager, you will oversee clinical trial databases and serve as the primary liaison between eClinical personnel and Sponsor personnel.ResponsibilitiesPrimary representative for eClinical Solutions and sponsor data management interactionResponsible for monitoring and ensuring adherence to study timelines and deliverablesAccountable for the overall quality of data management activities and deliverables at the study or program levelEnsure efficiency and consistency for data management tasks across programsCommunicate with global study teamsParticipate in client study kickoff and closeout/lessons learned meetingsCreate materials for and present at Investigator MeetingsDevelop content and deliver Sponsor CRA and/or site trainingDelegate tasks, support and provide guidance to study data management teamOversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help TextOversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specificationsParticipate in Internal System Testing (IST) on the database/user roles/edit check specificationsAssist with preparation for implementation of a centralized data management platform for strategic data cleaning and reportingUtilization of centralized data management platform including graphical patient profiles and operational analyticsCompile the sponsor UAT packageOversee and/or perform data review as documented in the Data Management Plan and Data Validation SpecificationsOversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting toolsOversee and/or perform data review for overall consistency and accuracyOversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical databaseOversee and/or perform query processing/resolutionProvide ongoing data management reports and metricsOversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the studyDefine and develop specifications for database, programming and/or edit check changes as needed throughout the studyTrack data management issues and ensure follow up to resolutionIdentify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action planMaintain data management study documentationPerform steps pertaining to database freeze/lock and coordinate all related activitiesOngoing evaluation of process and participate in process improvementAssist in the creation and review of SOPs, WIs, and training materialsMentor junior level staff and peers on all associated tasks within a studyParticipate in proposal defensesPerform other duties as requested by managementSkillsBachelor's degree in Pharmaceutical/Biotechnology or higher in health-related field preferred8+ years in Clinical Data Management experience preferredKnowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodologyStrong project management experience and project team leadership skills including work planning and work delegationExperience with EDC and performing data management activitiesExcellent verbal and written communication skillsProficiency in Microsoft Office Applications, specifically MS Project and MS ExcelExperience with EDC and Clinical Data Management SystemsCompany OvervieweClinical Solutions is a data intelligence hub.it transforms the way clinical data integration, aggregation, and analytics. It is a sub-organization of GI Partners. It was founded in 2006, and is headquartered in Mansfield, Massachusetts, USA, with a workforce of 201-500 employees. Its website is http://www.eclinicalsol.com.Company H1B SponsorshipeClinical Solutions has a track record of offering H1B sponsorships, with 2 in 2026, 10 in 2025, 7 in 2024, 8 in 2023, 5 in 2022, 5 in 2021. Please note that this does not guarantee sponsorship for this specific role.