Senior Manager, Clinical Data Management
Senior Manager, Clinical Data Management
Posted on :
08-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
08-05-2025
Job Description
Responsibilities:
- Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects.
- Efficiently plan coordinate and deliver complete high quality and reliable clinical trial data in a timely manner for assigned projects.
- Responsible for endtoend clinical data management activities and serve as a primary point of contact for internal and external study team members.
- Provide strong quality and project oversight over third party vendor responsible for data management deliverables.
- Take a leadership role to gather content and integration requirements for EDC and closely collaborate with partners supporting other data collection systems (eCOA External Data RTSM). Enforce data standard conventions and quality expectations for clinical data per defined processes.
- Author review/revise DM related study plans including Data Quality Management Plan Data Validation Plans Data Review Plan eCRF Completion Guidelines and other study documents to ensure quality and standardization.
- Chair Data Review meetings with cross functional study team members to ensure ongoing review of trial data currency quality and completeness.
- Represent DM on crossfunctional project teams & submission teams.
- Lead or support the Health Authority inspections and audits.
- Provide coaching and quality oversight of junior Data Management Leads.
- Act as core member of the study team and provides FSP/CRO/Vendor oversight for endtoend Data Management activities manage data currency throughout the trial and perform overall monitoring DM deliverables according to the Service Level Agreement (SLA).
- Lead/provide the relevant support to set up validate the standard eCRF library.
- Post Graduate degree with 6 years of experience or a bachelors degree with 8 years of experience in a relevant field such as Life Sciences Biostatistics Computer Science or a related discipline.
- Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors reputable CRO(s) and/or a Sponsor environment working on multiphase multitherapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
- Oncology experience required.
- Able to work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors.
- Sound knowledge of Clinical Drug Development Process FDA/ICH guidelines and industry standard practices regarding data management.
- Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
- Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.
- Excellent oral and written communication skills.
- Communicate effectively with senior management and crossfunctional teams.
- Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
- Knowledge of submission requirements e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA).
Employment Type
Full Time
Key Skills
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