Senior Data Scientist, Databricks, PySpark, SQL
DMV IT Service
AzureCloudPySparkPythonScikit-LearnSQLTensorflow
Principal Clinical Data Manager
Precision For Medicine
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
- Perform quality control of data entry as needed
- Provide input, assess and manage timelines and resource needs for assigned projects
- Develop CRF specifications from the clinical study protocol and coordinate stakeholder review/feedback
- Assist in building clinical databases and conduct database build UAT; maintain quality controlled database build documentation
- Specify requirements for edit checks and oversee development of edit check and manual data review specifications
- Create, revise, version and maintain data management documentation and Trial Master File completeness
- Train clinical research personnel on study-specific CRF, EDC, and project-related items
- Review and query clinical trial data according to the Data Management Plan and perform line listing reviews
- Run patient and study level status and metric reporting
- Perform medical coding 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
- Assist with SAS programming and QC of SAS programs used in Data Management when required
- Identify and troubleshoot operational problems based on metrics, audit reports, and stakeholder input
- Participate in protocol, SAP and CSR review and provide feedback when required
- Contribute to development and maintenance of SOPs and process documentation related to data management
- Attend strategy meetings, bid defenses, client engagements and provide leadership for cross-functional initiatives
- Train and ensure data management project team members are sufficiently trained
- Communicate with study sponsors, vendors and project teams regarding data, database or other project issues
- Present software demonstrations/trainings and department/company training sessions as needed
- 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
- 100% remote (preference to have someone on the east coast)
- 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
- Among other benefits
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 codingedit checksdata entry qualityCRF specificationsUATdata management documentationclinical trial data review
Soft skills
organizational skillscommunication skillsleadership skillsinterpersonal skillstraining skillsproblem-solving skillsproject managementstakeholder managementrepresentational skillsteam collaboration
