Term: 6 month Contract
Scorpion Therapeutics, Inc. is seeking a highly skilled and motivated Clinical Data Manager/Sr. Clinical Data Manager to join our dynamic team for 6 months. As a Clinical Data Manager, you will play a pivotal role in overseeing the collection, processing, and maintenance of clinical trial data. Your expertise will be vital in ensuring the integrity, quality, and accuracy of all clinical data, thereby contributing to the successful execution of our clinical research programs.
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, and publications/presentations
Creation of data tables and figures (i.e., swimmer plots, waterfall plots, spider plots) for publications/presentations
Qualifications and Requirements
Bachelor's degree in life sciences, data management, or a related field. Advanced degree is preferred.
Minimum of 5+ years of experience in clinical data management within the pharmaceutical or biotechnology industry.
Experience with CRO oversight
Strong understanding of GCP, CDISC standards, and other relevant regulatory requirements.
Experience working with EDC systems and data management tools (e.g., Medidata Rave, Oracle Inform, etc.).
Excellent analytical and problem-solving skills with a keen attention to detail.
Proficiency in data review, query management, and data cleaning processes.
Demonstrated ability to work independently as well as collaboratively in a fast-paced team environment.
Excellent communication skills, both written and verbal, and the ability to present complex information clearly and concisely.
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