Our clinical-stage vaccine client in Boston, MA is growing and looking to add a Sr. Clinical Data Manager (remote or hybrid) to their team! Role will be responsible for data management activities and vendor oversight of clinical trials from startup to closeout, as well as process improvement activities and department operational and quality excellence initiatives. Will work with internal colleagues and external vendors to ensure delivery to time, quality, and cost expectations, and will perform day-to-day data management activities according to ICH guidelines, regulatory requirements, and SOPs.
- Work closely with the CPM and responsible for oversight and execution of data management activities for assigned clinical programs including data timelines and key deliverables. May represent data management in the Core Clinical Team.
- Responsible for preparing, validating and maintaining clinical trial databases according to ICH/GCP guidelines and current regulatory requirements, directly or in collaboration with CRO.
- Lead and participate in database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals.
- Contribute (with Data Sciences) to data standards including CRF standards.
- Lead data validation specifications and programs for assuring the accuracy of clinical trial data, such as manual data review guidelines, computerized edit check programs and Data Management Plans (DMP).
- Responsible for executing or overseeing data cleaning activities through to database lock including generating and managing clinical trial data queries, data review listings, and coding specified clinical trial data (e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs).
- Works closely with Clinical Programming and Stats Programming to generate data listings/reports for on-going clinical data review.
- Leads and participates in data system development initiatives and database integration projects.
- Works directly with and oversees CROs and vendors for outsourced Data Management activities. Is responsible for CRO performance and data management metrics for assigned programs.
- Participates in outsourcing/vendor selection for Data Management services, EDC platforms, and software.
- Responsible for overseeing and reporting on data status, timelines, and data management metrics for assigned clinical projects.
- Reviews and provides input into clinical study documents, including protocols and monitoring plans.
- Supports CTM in coordination of receipt of all ancillary data (e.g. safety lab data, analytic lab data, IVRS randomization data) to ensure data is received at the time of database lock.
- Participates in SOP development, training of junior data managers, process mapping, and other departmental activities.
- BS or healthcare degree (science background) and 7+ years’ experience in a pharmaceutical/biotech, CRO setting
- Global/international experience required
- Expertise in EDC and industry standards including ICH-GCP guidelines, and CDASH/CDISC
- Expertise in ePRO and eDiaries
- Strong understanding of R, SAS, SQL and/or other clinical programming
- Strong understanding of clinical data coding classification systems (such as MedDRA, WHO-Drug) and data systems integration (labs, eDiaries, etc.)
- Seeking Boston local candidates to be on-site 2-3 days per week.
- OR can hire this position remotely
- Travel domestic and international – less than 10%.