Job-ID31508458Reference25-04462 Responsibilities: Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks They will ensure optimized data collection, flow and access across EDC and non-EDC data sources They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases The role will operate as a key member of the Clinical Operations team Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection Perform data entry and cleaning activities, including discrepancy management and query resolution Conduct data validation checks and implement quality control measures to ensure accuracy and completeness Collaborate with study team members to resolve data-related issues and discrepancies Generate and review data listings, summaries and reports for data review Serve as a primary or backup resource for issues about data management Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations Contribute to the development and validation of data management software Requirements: BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience 5-7 years of data management experience in the pharmaceutical or biotechnology industries Strong expertise in project/program management including stakeholder management Knowledge of industry standards (CDISC, SDTM, CDASH) In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11 Proven ability to preemptively identify data and system issues and mitigate risks to data quality Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data Experience in development and implementation of Clinical data management standards and procedures Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug
...Road Safety Technology Operator Help Us Save Lives on Connecticut Roads as our next Road Safety Technology Operator As a Road Safety... ...maintenance and equipment checks to ensure our life-saving tech is always mission-ready. Liaise with the Hub: Maintain constant...
...Road Service TechnicianDerby, Vermont, United StatesMonroe Tractor is a well-known and respected construction equipment and agricultural equipment dealer with over 75 years of experience servicing the northeastern US. With 18 locations throughout New York, Pennsylvania...
...Unsecured LendingPosition SummaryCitizens is seeking a dynamic Finance Director (SVP) to serve as the CFO and strategic finance leader... ...+Schedule: Monday through Friday (4 days in office required, 1 day remote)Work Authorization: This role is not eligible for new employer...
...design to field execution and long-term asset managementacross commercial and industrial portfolios, data centers, and complex... ...and EPMS controls, lighting system upgrades, energy brokerage, roofing and building envelope assessments, construction management, and...
...0 Number Of Positions 1 Work Schedule and Shift Requirements... ...from writing scripts and social media posts to conceptualizing campaigns and experiential marketing. You'll be counted on to provide... ...the flexibility to work from home, but may be invited to come into...