More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary:
The Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.
Responsibilities
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements.
Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection.
Perform data entry and cleaning activities, including discrepancy management and query resolution.
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
Collaborate with study team members to resolve data-related issues and discrepancies.
Generate and review data listings, summaries and reports for data review
Serve as a primary or backup resource for issues about data management.
Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
Contribute to the development and validation of data management software tools.
Qualifications
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
5-7+ years of data management experience in the pharmaceutical or biotechnology industries, preferably in smaller biotech sponsor environment.
Strong expertise in project/program management including stakeholder management.
Knowledge of industry standards (CDISC, SDTM, CDASH).
In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
Proven ability to preemptively identify data and system issues and mitigate risks to data quality.
Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
Experience in development and implementation of Clinical data management standards and procedures.
Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
Prior experience with Zelta by Merative (formerly IBM) CDM platform preferred.