Senior Clinical Data Manager

Senior Clinical Data ManagereClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.You will make an impact:As a Senior Clinical Data Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance / data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior Clinical Data Manager, you may delegate tasks / responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables.Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.Your day to day:Primary 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 managementTake the first step towards your dream career. Here is what we are looking for in this role.Qualifications:Bachelor'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 SystemsAccelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yourseClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome hereWe are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. #J-18808-Ljbffr