Data Management leadership for all aspects of the data management process to include responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to client quality expectations within project timelines and budgets.
This is a virtual position which can be home based anywhere in the US or Canada.
Essential Job Duties:
- Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
- 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 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 study initiation meetings.
- Provide DM project team leadership and accountability. Lead data focused internal project team meetings and meet frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental. Proactively identify potential risks/mitigations, effectively communicate data-driven discussions in order to achieve database lock dates.
- 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.
- Coordinate 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.
- Ensure study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
- Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
- Apply corrective interventions, where necessary, to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
- Provide leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
- Perform QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Provide feedback constructively on relevant issues and initiate process review, as appropriate.
- Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data. Utilize local laboratory systems and batch data load facilities where appropriate.