Data Scientist – Measurement
InMarket
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Principal Clinical Data Manager
Precision Medicine Group
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $133,000 - $180,000 per year
Job Level
Lead
About the role
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring back-up, continuity, responsiveness, and timely task completion
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- May perform quality control of data entry
- Provide input, assess and manage timelines; ensure clinical data management deadlines are met
- Assess resource needs for assigned projects
- Develop CRF specifications from the clinical study protocol and coordinate stakeholder review/feedback
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation
- Oversee overall quality of the clinical database
- Specify requirements for all edit check types and oversee development of edit check and manual data review specifications
- Create, revise, version and maintain data management documentation; oversee Trial Master File completeness
- Train clinical research personnel on study specific CRF, EDC, and other project related items
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation
- Liaise with third-party vendors (external data and EDC vendors) in a project-manager capacity
- May assist with SAS programming and quality control of SAS programs used in Data Management
- Identify and troubleshoot operational problems based on metrics, audit reports, and stakeholder input
- May assist in reviewing and providing feedback on protocols, SAPs and CSRs
- Participate in development and maintenance of SOPs and process documentation related to data management
- Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and client engagement meetings
- May review RFPs, proposals, and provide project estimates
- Provide leadership for cross-functional and organization-wide initiatives
- Train and ensure data management project team members are sufficiently trained
- Communicate with study sponsors, vendors and project teams regarding data, database or project issues
- Present software demonstrations/trainings and department/company training sessions
- May require some travel
- Perform other duties as assigned
Requirements
- Bachelors and/or a combination of related experience
- 10+ years for a Principal Clinical Data Manager
- Oncology experience
- 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 utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
- Preferred: Experience in a clinical, scientific or healthcare discipline
- Preferred: Dictionary medical coding (MedDRA and WHODrug)
- Preferred: Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
Benefits
- This role is also eligible for a discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- 100% remote (preference for East Coast)
- May require some travel
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementclinical database managementSAS programmingmedical codingCRF specificationsedit check developmentdata entry quality controlUAT (User Acceptance Testing)clinical trial data reviewdata management documentation
Soft skills
organizational skillscommunication skillsleadership skillsinterpersonal skillstraining skillsproblem-solving skillsproject management skillsrepresentational skillsresponsivenessteam collaboration
