- Lead study Data Manager for assigned studies.
- As the study data lead; be accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest delivery quality, while adjusting resource allocations accordingly.
- Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
- Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at site initiation meetings.
- Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary.
- Keep Clinical Pharmacology Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
- Anticipates and identifies operational and logistical challenges; including mitigation plans and risk management plans and reviews them with the Project Manager, Biometrics management, and the sponsor. Executes follow-through of mitigation plans to completion in a timely manner.
- Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
- Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
- Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received and the scope change processed.
- Demonstrates knowledge of DM utilized tools, systems, and processes.
- Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
- Plan Data Management resources for assigned studies with support from line manager
- Maintain accurate records of all work undertaken.
- Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
- Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate.
- Perform medical and medication coding.
- Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
- Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
- Actively promote Biometrics services to sponsors whenever possible.
- Performs other related duties as assigned by management
- Bachelors degree level or equivalent in a life science subject
- The successful candidate will have up previous experience within Clinical Data Manager with significant experience leading data management projects and sponsor management in Phase I and IIa clinical trial studies within a CRO and/ or Pharma.
- Electronic Data Capture (EDC) experience is preferred.
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