Clinical Data Manager/Senior Clinical Data Manager
Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to enrich for the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis, and management and in the future will be applied to other conditions beyond cancer.
Under the direction of the Director, Clinical Data Management, the Clinical Data Manager (CDM) will be responsible for supporting and managing the capture, quality, and analysis of data from multiple prospective, and retrospective clinical research programs. The CDM works collaboratively with internal and external colleagues and vendors to support clinical study objectives by ensuring the accurate and timely acquisition of clinical data via efficient Case Report Form (CRF)design, edit check design, and the query resolution process. The CDM will own data management activities including CRF design, database design, development of Clinical Data Management Plans, (CDMP), data entry and query resolution status tracking through database closure.
· Plan, manage, and coordinate data management activities and timelines for assigned clinical studies to ensure consistency of data across clinical programs and clinical program timelines.
· Review clinical study protocols and research plans to ensure data collection and data management meet established standards.
· Work closely with cross-functional clinical study team members to design clinical study databases, CRFs, and edit checks specifications.
· Lead User Acceptance Test (UAT) planning and execution for clinical study databases and associated CRFs and edit checks.
· Participate in vendor selection and management of interactions with clinical database vendors.
· Provide support to cross-functional study team members (Bio Stats, Clinical Development, Clinical Operations, Medical Affairs) via the creation of clinical data reports (e.g., data listings, query listings, query resolutions, data completion).
· Lead frequent review of clinical data and associated metadata to ensure data integrity, completeness, accuracy, consistency, and compliance of clinical data.
· Ensure study documentation is developed, maintained, and filed appropriately throughout the lifecycle of assigned clinical studies. This includes but is not limited to CDMP, CRFs, CRF Completion Guides (CCGs), edit check specifications.
· Participate in the development, review and implementation of department and company standard operating procedures (SOPs), and other study related documents (e.g., Operations Manuals, Monitoring Plans, Budgets, Statistical Analysis Plan).
·Minimum of 5 years of clinical research experience in the academic, pharmaceutical, biotechnology industry or some combination thereof with in-depth exposure to data management tasks. Additional experience in programming or analytics is a plus.
· At minimum Bachelor's Degree, preferably in health sciences field.
· Strong understanding of clinical trial and clinical data management principles from study planning through study closure.
· Experience with web-based electronic data capture, clinical data management systems, MedDRA, and WHO Drug.
· Experience with setting up clinical databases (such as Medidata) and experience managing clinical database vendors.
· Working knowledge of medical terminology, industry standards (CDISC, SDTM, CDASH), ICH/GCP guidelines, 21 CFR Part 11, and FDA guidelines.
· Excellent interpersonal and written communication skills demonstrated by the ability to present clear instruction/direction and influence at higher levels within the organization; including demonstrated presentation skills.
· Demonstrated ability to handle multiple projects and prioritize effectively with proven ability to work independently and in a team setting. Ability to solve problems collaboratively.
· Detail oriented and well organized.
· Advanced working knowledge of spreadsheet software is a requirement. Additional experience with tools or software used for data visualization and reporting (Python, R, SAS) and Office 365 is a plus.
· Some domestic travel may be required.