Senior Clinical Data Manager
Johnson and Johnson
Full time- 3+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Mar 27, 2024
- End Date: May 27, 2024
- 3+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Mar 27, 2024
- End Date: May 27, 2024
Skills:
- clinical research
- Clinical Trial
- Management
Job Description:
Responsibilities
- Sr. CDM will be involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
- Takes a leadership role with SRP/SRS to establish, align and confirm scientific clinical data review expectations for assigned trial(s).
- With the SRP/SRS, CRO and other functional partners in relation to CDM related activities:
- Reviews content for eCRF and other data collection tools
- Establishes conventions and quality expectations for clinical data.
- Set timelines and follow?up regularly to ensure delivery of all relevant Data Management milestones.
- Sr. CDM reviews complex scientific clinical study data, manages CDM and SRP/SRS related queries in eDC system and collaborates with Study Responsible Physician/Study Responsible Scientist (SRS/SRP). Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Sr. CDM will lead and/or attend meetings, as appropriate.
- Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
- Ensures real?time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary.
- Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
- Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
- Identifies and participates in process, system, and tool improvement initiatives within DM.
Qualification & Experience
- MS degree or PhD in Science or BS/BA degree in Science with professional experience equivalent
- Minimum of 3 years Data Management experience, specifically data review including patient profile experience, clinical data review or significant experience with clinical data review knowledge of medical terminology.
- Collaboration with Clinical teams
- Experience in clinical drug development within the pharmaceutical industry or CRO
- Strong scientific knowledge (educational/professional) preferably in the relevant therapeutic area
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Salary
Not Disclosed
-
Role
Manager
-
Area of Practice
- Clinical Data Management
-
Experience
3+ years
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