Why consider joining us? As a member of our thriving team, you have the opportunity to work alongside clinical research colleagues who understand the patients' mindset and their disease experiences. We help translate science into success for trials with a strategic and targeted, patient-centric approach. We are specialists who find solutions for novel trial challenges in our detailed approach throughout every study phase. From the beginning, we have nurtured an employee-centric company culture that focuses on patients' needs. Precision's team-focused culture ensures that team members will thrive and learn. These important key elements result in high quality work output while still having fun and giving back to the patient community.Position SummaryThe Manager, Clinical Database Management is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and software applications. Will interface directly with the internal team (ie Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Provides operational and technical training to end users and junior staff. This position may also participate in software validation. Manages the day-to-day activities of the Database 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 database management projects; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and database and/or applicable software-related issues.Essential functions of the job include but are not limited to:Oversees the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and studyProvides input and guidance to the design of clinical databases to the client and internal teamsOversees the building and supporting of clinical databasesOversees the development, testing, and validation of application programs and clinical databases to support client-related projects and third-party applications.May provide system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applicationsTroubleshoots and resolves software and clinical database problemsDevelops and maintains study-specific validation documentsMay provide data management support for client-related projects from CRF design to post database close and archivalMay design, develop and validate the Company's internal applications, client-related projects and third-party applications.Participate in software vendor selectionParticipate in conducting EDC demonstrations and trainingsParticipate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management, database management and applications development activitiesProvide technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior managementMay attend 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 meetingsProvide technical guidance and advice to key senior leadership on reasonable growth and process goals to assure data qualityRequires 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 Object Oriented Programming (C#, C++, VBS, etc ), scripting language (PERL, etc..), SAS, R, SQLExperience in clinical database management system development.Experience in a clinical, scientific or healthcare discipline.Experience in utilizing various clinical database management systemsBroad knowledge of drug, device and/or biologic development and effective data management practicesStrong leadership and interpersonal skillsUnderstanding of CDISC standards (CDASH, SDTM, ADaM, etc )1+ years of leadership experience"PreferredOncology and/or Orphan Drug therapeutic experienceExperience in business development and producing cost estimatesBase SAS(R), SAS/STAT and SAS/ACCESS softwareSAS Macro programming language"Advanced experience in Database Management, object oriented programmingAny 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. (C) 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@precisionmedicinegrp.com .