Clinical Data Manager/Sr. Clinical Data Manager (Early Development)

Scorpion Therapeutics is seeking a Clinical Data Manager/Sr. Clinical Data Manager to join their team. The role involves overseeing the collection, processing, and maintenance of clinical trial data to ensure its integrity, quality, and accuracy. The Clinical Data Manager will play a pivotal role in contributing to the successful execution of the company's clinical research programs.

• Participate in User Acceptance Test (UAT) testing
• Review edit check specifications
• Thoroughly review eCRF completion guidelines and annotated CRFs (aCRFs)
• Initiate and manage EDC and edit check specification updates throughout the study
• Thoroughly review draft listings, data management plans, and data validation manuals (DVMs)
• Create and implement team training materials on internal data review plan (DRP)
• Review and approve data transfer specifications (DTS) and data transfer agreements (DTA) between Scorpion, CRO, and other vendors
• Review and approve data management portion of the overall study budget
• Thoroughly review and approve IRT specifications document
• Initiate and manage IRT system updates throughout the study
• Ensure data completeness and accuracy through quality control measures
• Oversee reconciliation of patient samples at vendors versus sample collection reported in EDC
• Participate in data cleaning, query generation/closing, and resolution, and review of medical coding
• Conduct data quality audits
• Oversee data reconciliation activities, such as SAE reconciliation
• Manage and oversee data management vendors including CRO and consultants
• Compile and update data tables and figures for internal and external stakeholder review
• Work with the clinical development team to create, manage, and disseminate timelines for data deliverables.

• Participate in User Acceptance Test (UAT) testing
• Review of edit check specifications
• Thorough review of eCRF completion guidelines and annotated CRFs (aCRFs)
• Initiation and management of EDC and edit check specification updates throughout duration of the study, including ad hoc updates and those necessary due to protocol amendments
• Thorough review of draft listings, data management plans, and data validation manuals (DVMs)
• Creation and implementation of team training materials on internal data review plan (DRP)
• Review and approval of data transfer specifications (DTS) and data transfer agreements (DTA) between Scorpion, CRO, and other vendors
• Review and approval of data management portion of the overall study budget
• Thorough review and approval of IRT specifications document
• Initiation and management of IRT system updates throughout duration of the study, including ad hoc updates and those necessary due to protocol amendments
• Quality control for data completeness and accuracy
• Oversee reconciliation of patient samples at vendors versus sample collection reported in EDC across external vendors
• Participate in data cleaning, query generation/closing and resolution and review of medical coding as needed
• Conduct data quality audits
• Overseeing data reconciliation activities (i.e. SAE reconciliation)
• Management and oversight of data management vendors including CRO and consultants
• Compiling and updating data tables and figures for internal (i.e., Corporate Executive Team) and external stakeholder review (i.e., Safety Evaluation Team)
• Work with the clinical development team to create, manage, and disseminate timelines for data deliverables including for safety review meetings, IB/DSUR annual updates, interim and final database locks, external stakeholder review.

• Competitive salary and compensation package
• Opportunity to work with a highly collaborative team
• Chance to contribute to the discovery and development of small molecule cancer medicines
• Access to cutting-edge technologies and approaches in small molecule drug discovery
• Opportunity for professional growth and development
• Work in a fast-paced and dynamic environment
• Excellent work-life balance
• Equal opportunity employer with a commitment to diversity and inclusion
• Fully vaccinated workplace with accommodations for medical or religious reasons