Clinical Data Manager

Recent experience in Data Management and CRO oversight of a global Covid-19 study

Combines clinical data management expertise with great Vendor Management and CRO Oversight experience

Certified Project Manager

Already placed twice with best references via K-Recruiting

Coordination of the Clinical Data Management for vaccine trials

Review of (e)CRFs

Transfers of data collected outside of the eCRF

Overseeing the data management tasks of CRO / vendor during the study start-up process

Data transfer reviews, coding reviews

Project Management

Oncology, Respiratory COVID-19 trials

Point of contact for partners and subcontractors on data management deliverables

Provided data management and technical expertise for end-to-end DM activities with CROs and key decisionmakers

Supported clinical data management activities

Organized and conducted clinical data management activities Participated in protocol development and created/validated data management plan documents (SDTM e-CRF, Data Validation plan, Clean Patient Tracker)

Validated or performed User Acceptance Testing of study set up of EDC clinical database

Supporting sponsor clinical data medical review

Escalated unresolved data or compliance issues to managers and worked with CROs, partners, vendors and internal teams for resolution

Ensured the final deliverables are provided to the Statistician team and provide support for data analysis

Contributed to developing and implementing new data visualization tools (Spotfire, Microsoft Power BI)

Provided review and input on developing, revising, and maintaining core operating procedures and templates

Provided support or assist Quality assurance department in conducting audits involving data management activities

Monitored data management progress and quality using JReview and BOXI in the EDC system

Developed and maintained relationships with data management vendors

Managed data from project start to database lockdown

Oversaw the CDASH e-CRF Standards global library

Provided data management status, cycle time, and productivity metrics

Led and reviewed Data Management Plans, Quality Management Plans, and SDTM mappings

Conducted and reviewed data transfers and coding

Reviewed Data Validation specs and performed UAT of clinical data models

Built e-CRF drafts in EDC RAVE’s Architect Module

Oversaw testing of system edit/validation checks and tools for data review

Conducted close-out activities

Supported external data integrations and reconciliation (e.g., lab data, IVRS, ePRO)

Reviewed TFLs for Data Review Meetings, CE-models, and decision-analytical models

Managed database lock activities

Overview for final quality check

Accounted for all the Data Management deliverables

Ensured close out activities

Managed DM deliverables at trial and cross-trial levels with cross-functional teams and external providers

Locking of the database

Partnered with Data management leader DML providing project status, issue awareness

Data transfer review

Supported the Global Trial Manager for investigator meetings and monitor training

Studies in Oncology and Dermatology