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Manager Data management - REMOTE

Company: Precision Medicine Group
Location: Nashville
Posted on: November 22, 2021

Job Description:

Position SummaryThe Manager, Data Management manages the day-to-day activities of the Data Management function in accordance with Standard Operating Procedures (SOPs), regulatory directives; and study specific plans with an emphasis on effective resourcing and development of personnel. Provides oversight and leading activities for data management projects; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and site issues. In addition, manages all aspects of the clinical trial data management process from study start up to post database lock for Electronic Data Capture (EDC) and paper CRF trials. This position will also oversee and/or perform database development and testing.Essential functions of the job include but are not limited to:DM Oversight of sponsor programs. May be the primary DM contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner for all studies for these clients. May include DM oversight of sponsor programs.Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcingProvide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholdersMay assist in building clinical databasesMay conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specificationsResponsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.May review and query clinical trial data according to the Data Management PlanMay perform line listing data review based on the guidance provided by the sponsor and/or Lead DMMay run patient and study level status and metric reporting. Oversee the development requirements and frequency of report delivery.May perform medical coding of medical terms relative to each other in order to ensure medical logic and consistencyMay coordinate SAE/AE reconciliationLiaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverablesMay assist with SAS programming and quality control of SAS programs used in the Data Management departmentIdentify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholdersMay assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the projectParticipate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management, database management, applications development and SAS programming activitiesProvide technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior managementAttend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetingsReviews Request for Proposals (RFP), proposals, provide project estimatesProvide leadership for cross-functional and organization-wide initiatives, where applicableEnsures that all data management project team members have been sufficiently trainedCommunicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issuesPresent software demonstrations/trainings, department/company training sessions, present at project meetingsRequires some travelMay perform other duties as assignedQualificationsMinimum Required:5+ years' experienceBachelors and/or a combination of related experienceOther RequiredProficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.Able to handle a variety of clinical research tasks.Excellent organizational and communication skillsProfessional use of the English language; both written and oral.Experience in utilizing various clinical database management systemsBroad knowledge of drug, device and/or biologic development and effective data management practicesStrong leadership and interpersonal skills1+ years of leadership experiencePreferredExperience in a clinical, scientific or healthcare discipline.Dictionary medical coding (MedDRA and WHODrug)Understanding of CDISC standards (CDASH, SDTM, ADaM, etc....)Oncology and/or Orphan Drug therapeutic experienceAny data provided as a part of this application will be stored in accordance with our Privacy Policy .Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. A 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@ .by Jobble

Keywords: Precision Medicine Group, Nashville , Manager Data management - REMOTE, Executive , Nashville, Tennessee

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