Lead Clinical Data Manager

Responsibilities: Leads oversight of all data management activities including deliverables for the build, collection, review, monitoring of clinical data including CRF data, ePRO, and internal and external laboratory data to ensure that studies are executed within the agreed timelines and according to applicable SOPs, global standards, and working practices.
Responsible for the strategy, monitoring, and timeliness of data cleaning process performed by the CRO from start up through data archival including activities related to cleaning, acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.
Ensures effective quality oversight and management of external partners (e.
g.
, CROs, technology providers, etc.
) Supports Sponsor oversight by developing reports and applying metrics and key performance indicators (KPIs) to monitor vendor performance and proactively provides risk and mitigation feedback directly to vendor.
Participates in study level RFP assessment, budget review and invoice approval.
Lead the development of the data management data review strategy, ensures the creation of robust study-specific data review specifications and aggregating data review.
Participates in cross-functional data review meetings and activities in support of key reporting events or database lock plan.
Approves and manages the Data Management Plan (and associated documents), edit check, data review and query management, data access and visualization, data cleaning and coding, metrics reporting, drives interim and final cleaned database freeze and release strategy, and regulatory submission related activities.
Coordinate with internal Medical, Biostatistics, and Programming team to understand and drive data delivery for business needs and priorities.
Ensure operational excellence of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, metrics reporting, and regulatory submission related activities.
Provide input to the study risk registers for all data management, eSource, and ePRO risks.
Point of escalation for all data management study issues.
Perform oversight of outsourced MedDRA and WHODrug dictionary coding activities to ensure quality and productivity are within established standards.
Function as dictionary subject matter expert (SME) to provide guidance for all dictionary related issues and strategies Provide support to activities delivering implementation or integration of dictionary or data management systems using industry standard methodologies.
Other duties as assigned.
Requirement: Bachelor's degree minimum requirement and 8+ years of relevant data management experience in biotechnology, pharmaceutical or CRO settings.
Have at least 2-3 years' experience in the medical device, pharmaceutical, or biotech industry with emphasis in coding clinical data with standard dictionaries (e.
g.
, MedDRA, WHO-DD).
Proficient experience using commercial clinical data management systems and/or EDC products (e.
g.
, RAVE EDC).
Experience with implementation and data transfer of external data to clinical database (e.
g.
, external laboratory and Electronic Patient Reported Outcomes (ePRO) data and eSource).
Experience using data visualization tools (e.
g.
, Spotfire, J-Review) Proficient in development and maintenance of the Data Management Plan, data review and query management, data access and visualization, metrics reporting, external data transfer into clinical database, and database release activities.
Understanding of data reconciliations between clinical database and other databases (e.
g.
, Product Safety and LIMS) Understanding of statistical outputs (tables, listings and graphs) to ensure data review reports match program and study needs.
Understanding of regulatory requirements for license applications with US FDA and other regulatory agencies Understanding of CDISC standards including CDASH, SDTM, and ADAM.
Global clinical trial expertise and prior therapeutic experience in vaccines studies.
Interface with external vendors developing systems/applications for clinical trial data collection (e.
g.
ePRO/eCOA) to ensure quality and timely deployment.
Experience in developing the tools/reports to support CRO oversight activities.
Demonstrates strong verbal and written communication skills including ability to communicate remotely.
Detail oriented, ability to multi-task with strong prioritization, planning and organization skills.
Good written and spoken English