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Manager, Clinical Database management - REMOTE

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

Job Description:

Position Summary

The 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 (i.e. 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 study
Provides input and guidance to the design of clinical databases to the client and internal teams
Oversees the building and supporting of clinical databases
Oversees 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 applications
Troubleshoots and resolves software and clinical database problems
Develops and maintains study-specific validation documents
May provide data management support for client-related projects from CRF design to post database close and archival
May design, develop and validate the Company's internal applications, client-related projects and third-party applications.
Participate in software vendor selection
Participate in conducting EDC demonstrations and trainings
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management, database management and applications development activities
Provide technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior management
May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
Reviews Request for Proposals (RFP), proposals, provide project estimates
Provide leadership for cross-functional and organization-wide initiatives, where applicable
Ensures that all data management project team members have been sufficiently trained
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
Present software demonstrations/trainings, department/company training sessions, present at project meetings
Provide technical guidance and advice to key senior leadership on reasonable growth and process goals to assure data quality
Requires some travel
May perform other duties as assigned

Qualifications

Minimum Required:
5+ years' experience
Bachelors and/or a combination of related experience

Other Required
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
Able to handle a variety of clinical research tasks.
Excellent organizational and communication skills
Professional use of the English language; both written and oral.
Experience in Object Oriented Programming (C#, C++, VBS, etc.---), scripting language (PERL, etc..), SAS, R, SQL
Experience in clinical database management system development.
Experience in a clinical, scientific or healthcare discipline.
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong leadership and interpersonal skills
Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.---)
1+ years of leadership experience"

Preferred
Oncology and/or Orphan Drug therapeutic experience
Experience in business development and producing cost estimates
Base SAS -, SAS/STAT and SAS/ACCESS software
SAS Macro programming language"
Advanced experience in Database Management, object oriented programming

Any 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. - 2020 Precision Medicine Group, LLC

If 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 .

Keywords: Precision Medicine Group, Fort Worth , Manager, Clinical Database management - REMOTE, IT / Software / Systems , Fort Worth, Texas

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