Clinical Data Manager
Dragonfly Therapeutics seeks a Clinical Data Manager with relevant Clinical Data Management experience to join our Clinical group. This role will report to the Associate Director, Clinical Data Management. This role is responsible for the oversight of all aspects of the clinical trial data management process from study start-up through study closeout. Job responsibilities include, but are not limited to, the design and implementation of the clinical database, the review of the clinical data to ensure high-quality deliverables, and the reconciliation of external data. This role will collaborate with the Clinical Operations and Clinical Development team, and with other functions as applicable, to ensure project deliverables are met, including data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.
Responsibilities:
- Leads and provides clinical study level data management oversight of outsourced clinical trials for early stage (phase I-II) studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables
- Act as a liaison with CROs, third party data vendors, and EDC vendors
- Oversees clinical database design and production, ensuring that CROs, vendors, and internal staff meet the highest quality standards, ensuring completeness, correctness, and consistency of clinical data and outputs
- Oversees the creation and approval of Data Management study documentation including, but not limited to, eCRFs, clinical database specifications, CCGs, DMPs, data handling guidelines, data review plans, data transfer specifications/agreements, external vendor data reconciliation plans, and SAE reconciliation plans
- Reviews clinical data listings and reports on performance and quality; review clinical data within studies and across programs for trend analysis
- Understands all aspects of the study protocols and statistical analysis plans as they relate to data management deliverables and serve as a knowledgeable point person on study teams for data management activities
- Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed and communicates project status, metrics, risks, and issues
- Assist as needed with clinical documents such as clinical protocols, investigator brochure updates, annual reports, and status updates
Qualifications:
- Bachelor’s degree, or equivalent, in a biomedical, life science, or related field of study
- Minimum of 3 years of relevant clinical data management experience within the Pharma, Biotech, or CRO industry
- Oncology or immunology/inflammation experience required
- Experience with CRO vendor oversight is preferred
- Familiarity with advanced Excel functions, SAS, and SQL is a plus
- Strong organizational skills along with a creative, proactive, problem-solving, and flexible attitude
- Strong written and verbal communication skills
- Ability to collaborate effectively with the cross-functional study team and external partners
- Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC) (Oracle Inform and Medidata Rave), clinical data management systems, and industry wide coding dictionaries (MedDRA and WHODrug)
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
