- Collaborate and functionally report to Lead DM (LDM) for studies which include but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
- As a lead data reviewer and support to the lead Data Manager, you will perform all data operational tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and Sponsor) are achieved.
- Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, Covance global harmonized SOPs or client SOPs, and the specified standards of GCPs.
- Work with the LDM to build study milestone timelines and demonstrates capability to read and follow study timelines for on-time deliverables. And capable and knowledgeable on study design to make suggestions to study timelines when warranted.
- Assist or lead the internal and external Data Management meetings
- Assist or lead to write, update/review and approve all required trial data management documentation; including, but not limited to:
- Study-specific case report forms
- CRF Completion Guidelines
- Data Management Plan
- Data Quality Checks (edit checks)
- Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
- Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
- Track scope changes and work with the Lead DM to ensure that Sponsor approval is received, and the scope change processed.
- Supports the training of new staff on project specific Data Management processes. Ensures service and quality meet agreed upon specifications per the DMP and scope of work
- Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
- Coordinate with DM study team to ensure the receipt and inventory of all data related information is delivered within agreed upon timelines.
- Ensure all appropriate documentation and procedures are performed upon project completion for operations team. Assist or lead the managing of the DM study team ensure client satisfaction is achieved through delivery of quality data
- Assist or coordinate the internal or external meetings as appropriate.
- Attend client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
- Assist or provide reports to Sponsor and internal team as dictated by project need
- Supports the training of new staff on project specific Data Management processes.
- Assist or lead with the completion of Database Lock and Unlock activities with LDM.
- Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
- Performs other related duties as assigned by Line Management.
- University/College Degree (Life Science- preferred)
- Certification in allied health profession from an appropriate accredited institution will be an advantage (E.g., Nursing certification, Medical or laboratory technology)
- 6 to 8 years of DM experience
- Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred
- Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
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