Clinical Data ManagerResponsibilities:Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study closeThis includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locksThey will ensure optimized data collection, flow and access across EDC and non-EDC data sourcesThey are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databasesThe role will operate as a key member of the Clinical Operations teamDevelop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreementsDesign case report forms (CRFs) for electronic data capture (EDC) systems for data collectionPerform data entry and cleaning activities, including discrepancy management and query resolutionConduct data validation checks and implement quality control measures to ensure accuracy and completenessCollaborate with study team members to resolve data-related issues and discrepanciesGenerate and review data listings, summaries and reports for data reviewServe as a primary or backup resource for issues about data managementEnsure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulationsContribute to the development and validation of data management software tools.Requirements:BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience5-7 years of data management experience in the pharmaceutical or biotechnology industriesStrong expertise in project/program management including stakeholder managementKnowledge of industry standards (CDISC, SDTM, CDASH)In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11Proven ability to pre-emptively identify data and system issues and mitigate risks to data qualityKnowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical dataExperience in development and implementation of Clinical data management standards and proceduresExperience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.