The Clinical Data Manager II or Senior Clinical Data Manager (CDM II/Sr. CDM) will provide oversight of, assist in the coordination of, and partake directly in the data management activities from study start-up, data processing, and database close-out in a paper or electronic environment for projects sponsored by Aspyrian Therapeutics where the activities are conducted in-house or by CROs.
The CDM II/Sr. CDM will have advanced knowledge of GCP/ICH standards, 21 CFR Part 11, and clinical trial processes as well as and be proficient in all aspects of data management from study start-up to study close-out, have experience in multiple Electronic Data Capture (EDC) environments, experience in Phase I, II, or III oncology studies, and experience in the oversight of CROs and 3rd party data vendors; in addition, the candidate will have experience with implementing CDISC CDASH CRF Standards and CDISC SDTM mapping, as well as knowledge of ADaM datasets and clinical trial SAS programming as related to data quality edit checks, data review, listings and reports, and tables/figures/listings (TFLs) is desired.
The CDM II/Sr. CDM will report to the Manager of Clinical Data Management or Director of Clinical Data Management (depending on level hired) and work closely with the Clinical team.
Key Duties and Responsibilities
- The CDM II/Sr. CDM is primarily accountable for the support of acquisition, transit, cleaning, reporting and overall quality of Aspyrian clinical study data from Phase I studies through Regulatory submissions. Ability to interact collaboratively cross-functionally, with external data vendors and as well as oversee CROs is a critical responsibility.The CDM II/Sr. CDM will act as the primary contact and provide oversight for all data management related activities outsourced to CROs and external vendors for one or more assigned studies.
- Responsible for data management activities supporting Aspyrian clinical programs from DM strategy, database set-up through database lock and CSR/submission
- Anticipate data management project requirements, institute, and manage appropriate actions to ensure timelines and project goals are met
- Responsible for completeness, timely delivery, and quality of clinical trial data from Aspyrian programs
- Participate in vendor evaluation, qualification, and selection, as needed
- Serve as DM representative at study team meetings and as primary contact for internal departments and external vendors; develop, track, analyze, and provide regular status reports on vendor activities as well as internal data management performance metrics
- Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors with respect to key performance indicators, metrics, and program level deliverables and timelines. Assess metrics for vendor quality and efficiencies, and escalate issues as needed
- Participate in protocol design and review, providing key input related to the operationalization of the design and data collection, while ensuring consistency and that standards are followed
- Develop or review key documents such as data collection instruments, database design specifications, Data Management Plans, Edit Check Specifications, data transfer specifications, SDTM mapping, CRF Completion Guidelines, Manual Review Guidelines, or Data Entry Guidelines
- Develop User Acceptance Testing (UAT) plans, coordinate, and participate in UAT
- Review site completed electronic case report forms (eCRFs) or paper CRFs for completeness and content, when applicable
- Review or perform external data reconciliation (i.e. laboratory data), and SAE reconciliation
- Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues
- Ensure proper closeout and archiving of data management study related materials, i.e. DMPs, database change documentation, validation documents, and final patient casebooks in paper or electronic format
- Ensure compliance with all applicable laws, regulations, and regulatory guidelines
- Understand and follow applicable Aspyrian SOPs. May contribute to the development and implementation of data management department policies, standards, and process improvement initiatives
- Provide leadership, training, and support to new Aspyrian Data Managers as department grows
- Keep abreast of literature and advancements in data management technologies, standards, and best practices while informing Aspyrian Clinical so they may be considered and/or applied to Aspyrian drug development programs.
- Perform other duties as assigned by management.
Desired Education, Skills, and Experience
- University/college degree is required, major in life science preferred
- Minimum 5 years of relevant research, pharmaceutical, biotech, or CRO experience in data management
- Must be proficient in all aspects of data management from study start-up to study close
- Knowledge of medical terminology, coding processes using MedDRA and WhoDRUG, and database design concepts
- Working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC CDASH standards and SDTM/ADaM specifications
- Excellent organizational skills with great attention to detail and the ability to multitask
- Excellent verbal and written communication skills, as well as inter-personal skills and oral presentation abilities
- Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Medical, Safety, CMC, Pre-Clinical, Stats, etc.)
- Ability to work proactively and effectively in a fast paced, high change environment
- Demonstrated initiative and resourcefulness
- Ability to represent Aspyrian in a professional manner
- Assumes responsibility and accountability for results
- Proficient computer skills including MS office products
- The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize.
Location: San Diego, CA
Min. Experience: Some Experience