Clinical Data Manager
Athira Pharma Bothell, WA
- Posted: over a month ago
- Benefits: 401k, dental, life insurance, medical, vision
Position: Clinical Data Manager / Sr. Clinical Data Manager
Regions: Seattle/Bothell, WA
Our mission is to restore lives by advancing bold therapies, thoughtfully and urgently. We are working to provide better care for people through innovative research and accessible products. Using our platform of disease-modifying regenerative small molecules, our current focus is on neurological diseases. An estimated one billion people around the world suffer from neurological disorders including Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, and more. With both a discovery arm and a research and development arm, we are positioned to lead the development of disease-modifying, life changing therapies addressing one of the largest and most critical unmet medical needs today.
About this role:
Athira is seeking a full-time Clinical Data Manager (CDM) with strong data analytics skills and obsession for quality. The CDM is responsible for managing the full lifecycle of study data to ensure integrity, quality, and timely delivery of clinical data.
· Act as data manager on one or more clinical trials
· Liaise effectively with data management vendors involved to support clinical study
· Create data management plan (DMP) and appendices for assigned study
· Design/review case report form (CRF)/electronic CRF from protocol
· Create/review CRF completion guidelines
· Perform database design, set-up, user acceptance testing (UAT)
· Define, review, and validate edit checks
· Perform data review and ensure timely resolution of queries
· Review and verify electronic data received from outside vendors
· Review and verify data outputs (listing, tables)
· Evaluate study data for protocol compliance
· Issue periodic data quality and data management status reports to track study progress
· Participate in the completion of all quality control measures for database lock
· Provide training on data management procedures and systems as needed
· Identify issues and challenges and work with Clinical Lead to resolve any matters
· Participate in development of a protocol/study to optimize the collection of accurate and high-quality data
· Act as subject matter expert for data management issues
· Complete studies/projects ensuring completeness, documentation and storage
· Ensure compliance with Good Clinical Data Management Practices (GCDMP)
· Bachelor’s degree required (advanced degree preferred but not required)
· 3 years’ experience as a CDM at biotech, pharma, or CRO
· Proficiency in the development and use of commercial EDC products
· Experience using SAS and relational databases (e.g., MS SQL Server, MS Access, or Oracle) favorable
· Working knowledge of FDA regulations/ICH/ GCP/GCDMP guidelines
· Excellent written and verbal communication skills
· Exceptional attention to details and quality
· Ability to work independently and collaboratively
· Strong data analytics and presentation skills
· Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
· Flexible attitude with respect to work assignments and new learning
· Conscientious, influential person with an outstanding work ethic and strong personal discipline
· Proficiency with MS Office products Word, Excel, PowerPoint, Share point
· Current authorization to work in the US
Apply by emailing your resume and cover letter to: email@example.com
Athira is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.
Athira PharmaWhy Work Here?
Advancing New Therapies for Neurodegenerative Diseases
Athira Pharma is a drug development company striving to improve human health by advancing new therapies for neurodegenerative diseases like Alzheimer’s and Parkinson’s. Our innovative approach is focused on turning brain degeneration into regeneration, achieved by re-establishing lost connections and restoring lost function.