Senior Clinical Data Manager
Precision For Medicine
Senior Clinical Data Manager
Precision For Medicine
full-time
Posted on:
Origin: • 🇷🇴 Romania
Visit company websiteJob Level
Senior
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 performance
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- Perform or oversee quality control of data entry
- Provide input, assess and manage timelines; ensure clinical data management deadlines are met
- Assess resource needs for assigned projects as needed
- 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 and oversee database quality
- 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 ensure completeness for the Trial Master File
- Train clinical research personnel on study specific CRF, EDC, and other project items
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review per sponsor or Lead DM guidance
- 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
- 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 team input
- Assist in reviewing and providing feedback on protocols, SAP, and CSRs if required
- Participate in SOP development and maintenance related to data management and database management
- Attend strategy meetings, bid defense prep, bid defenses, capability presentations, and potential client engagement meetings
- Review RFPs, proposals and provide project estimates
- Provide leadership for cross-functional and organization-wide initiatives and train project team members
- Communicate with study sponsors, vendors and project teams regarding data, database or project issues
- Present software demonstrations/trainings, department/company training sessions, and present at project meetings
- May require some travel
- Perform other duties as assigned
Requirements
- Bachelors and/or a combination of related experience
- Must have at least 8+ years’ experience
- Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
- Must have hands on set up 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 presentational 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…)
- Preferred: Oncology and/or Orphan Drug therapeutic experience
