This is an exciting time to join Candel Therapeutics and in this role you will be able to take charge of creatively working to transition our current clinical database systems to BLA/inspection readiness. This role will allow you to take charge of this entire process while also rolling up your sleeves and improving systems.
The Clinical Data Manager will have primary responsibility for all aspects of data management for clinical studies. This includes managing third party data management vendor activities which can include development of data management plans, database development and validation.
- Manage all aspects of data management for clinical studies for new and ongoing trials.
- Manages third party data management vendors activities including timelines, database build, review of data transfer specifications, data cleaning, query management, reconciliation and ensuring transfers and data delivery.
- Participate in reviewing request for proposals and providing feedback (SOW, budgetary, contractual) for the data management vendors.
- Provide input on clinical study protocols and other clinical trial documents
- Provide input for key clinical data management deliverables, including: Case Report Form (CRF) design, annotation, database design specifications, data entry guidelines, data management plans, edit check specifications, validation check testing and approval, and electronic data transfer agreements.
- Manage and participate in data review with clinical study teams, safety and biostatistics throughout the study.
- Bachelor’s degree with at least 5+ years or an advanced degree with at least 3 years of data management in the pharmaceutical industry or relevant experience. Experience in a small company is a plus.
- Excellent knowledge of GCP, ICH, 21CFR Part11 and other relevant regulatory guidelines and standards
- Strong project management skills and experience managing data
- Working knowledge of regulatory requirements for data management of clinical studies including Clinical Data Interchange Standards Consortium (CDISC) standards including SDTM and AdAM data submission standards.
- Experience with data clean-up and data preparation for NDA/BLA submissions
- Knowledge of SAS and statistical programs used for analysis
- Understanding of HIPAA and the importance of patient data privacy
- Excellent written and verbal communication skills
- High attention to detail and data accuracy
- Proven ability to manage multiple projects, prioritize and thoroughly follow-up on assigned tasks.