Reports to: Director, Clinical Operations
Job Code: 2017-70-5
The Clinical Data Manager/Clinical Programmer contributes to the Company’s drug development and discovery programs by providing oversight of data management activities, ensuring quality and timely data management (DM) deliverables from Contract Research Organizations (CROs), including ensuring consistently high standard database(s) with respect to cost, quality and timelines. The Clinical Data Manager/Clinical Programmer will work under general direction.
- Performs various activities to support the clinical operations team including: ensuring data management activities for clinical trials are completed in a timely and accurate manner and providing technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures
- Evaluates/qualifies data management CROs, by providing technical review and input on scope of work, bid proposals, and on CRO selection
- Provides expertise on draft protocols and data management issues to clinical teams
- In collaboration with Clinical Project Management, leads CRF development in alignment with the protocol and study goals
- In collaboration with Clinical Project Management, leads the development of database specifications, validation plans, and data management plans; ensure all are aligned with case report forms, protocol, and safety data standards; uses and enforces CDISC STDM and ADaM standards
- Monitors CRO performance including CRO compliance with applicable DM SOPs, safety data standards, and regulatory guidance; perform QC on “clean” data from CROs; provides feedback and ensures corrective actions are implemented
- Prepares ad hoc datasets for internal analyses and abstract submissions including merging datasets from various sources to create required data cuts needs for the activity
- Ensure complete and consistent medical term coding using appropriate dictionaries
- Ensures consistency of SAE data fields and content across study and PVG databases
- Contributes to the compilation and review of datasets which will support submissions to regulatory authorities such as in IND filings, IND annual reports/DSURs, NDAs
- Supports overall corporate growth by meeting or exceeding metrics for study starts, database locks and scientific publications by providing timely and quality DM deliverables.
- Complies with all applicable policies regarding health, safety, and environment
- BS in life sciences and at least three -five (3-5) years relevant work experience in data management to include data management, clinical operations, and knowledge of the oncology therapeutic area; or equivalent
- In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
- Strong understanding of database design, EDC, medical term coding and CDISC
- Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities; demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
- Experience of clinical databases, multiple clinical data management systems and electronic data capture (EDC)
- Demonstrated understanding of clinical data system design / development / validation and system interoperability
- Strong communication and interpersonal skills
- Technical understanding of tools such as SQL and SAS including, at a minimum, intermediate SAS programming skills
- Working knowledge of GCP and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards preferred
- Ability to work independently and collaboratively in a team-based environment
- Must be proficient in MSOffice ( Word, PowerPoint, Excel) and other relevant software
- Ensures CRO compliance with applicable DM SOPs, safety data standards, and regulatory guidance
GlycoMimetics, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter to HR@glycomimetics.com and reference job number 2017-70-5 in the subject line.