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Clinical Data Manager II – Senior Clinical Data Manager
Precision For MedicineClinical Data Manager II/Senior Clinical Data Manager responsible for managing clinical trial data management processes. Leading data management for projects and ensuring quality compliance and timely delivery.
About the role
Key responsibilities & impact- Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
- Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
- Review and query clinical trial data according to the Data Management Plan.
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
- Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables.
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
Requirements
What you’ll need- Bachelors and/or a combination of related experience
- 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
- Set up and Database migrations experience
- Oncology experience preferred
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- 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.
Benefits
Comp & perks- N/A 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
ATS Keywords
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Hard Skills & Tools
clinical trial data managementdata entry guidelines developmentdatabase build UATdata management documentationdata reviewdatabase migrationsclinical database management systemsdata management practicesclinical researchoncology
Soft Skills
organizational skillscommunication skillsleadership skillsinterpersonal skillsproblem-solving skillsresponsivenesstraining skillsattention to detailtime managementrepresentational skills