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Principal Clinical Lead Data Manager (home-based in the US)

Company: Premier Research
Location: East Hartford
Posted on: January 15, 2021

Job Description:

DescriptionPosition at Premier Research Group LimitedPremier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.We---re looking for a talented and energetic Principal Lead Data Manager to join our teamWorking at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of itWhat you---ll be doing:Independently lead end-to-end data management activities, including accurate and timely database design, database setup (including CRF and Non-CRF collection tools), data cleaning, and data management documentationPrepare the data management plans (DMP), data validation plans, completion guidelines, data management reports and other documents as requiredParticipate in and coordinate study team review of CRFs for potential data collection, database structure, or data entry problems as well as to ensures all captured data follows the rules outlined by the protocol and data management planManage the development of the data validation plan per the protocol and ensures user acceptance testing of CRFs and associated edit checks are completed in accordance with project timelinesManage the progress of data cleaning activities including the generation and resolution of queries and discrepanciesEnsure the accurate and timely reconciliation of third party data with Clinical Data Management System (CDMS) data.Track CRFs as they are processed through the Data Management departmentInteract with the Project Manager or designee on a continual basis throughout the course of the study, when applicable.Liaise with the sponsor as needed to discuss issues and provide data management updatesEnsure the Trial Master File (TMF) is accurate and contemporary at all times throughout the lifecycle of the trialMentors and trains Data Managers and Lead Data ManagersYou---ll need this to be considered:Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], along with 8 years of practical experience leading database management activities and using commercial clinical data management systems and/or EDC products (e.g. - Oracle RDC / Inform, Medidata Rave, DataLabs, etc; proficiency in the Microsoft Office SuiteProven ability to mentor others by instructing and developing capabilitiesExcellent English verbal and written communication skillsProven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownershipMust have ePro experienceStrong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Keywords: Premier Research, East Hartford , Principal Clinical Lead Data Manager (home-based in the US), Executive , East Hartford, Connecticut

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