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Lead data manager for clinical trials (castano primo)

Castano Primo
Psi Cro
Pubblicato il 14 marzo
Descrizione

We’re over 2,700+ strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way. Job Description The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects. Communication Primary communication point for project teams and company departments with regard to clinical data management Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting Data Management Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables. Primary responsibility for clinical data management activities within clinical projects, including, but not limited to: Study documents review Data Management plan and other project‑specific guidelines and instructions development and review Co‑ordinate/perform user acceptance testing Development of Data Validation Plan/Edit Check Specifications Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data Non‑CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues) Database edits (paper CRF studies) Manual CRF review (non‑medical checks) Clinical database lock Coordination and supervision of processing, dispatch and archiving of CRFs/queries Input into design of CRFs and other data collection forms; review Case Report Formdesign for accuracy and adherence to protocol Development of CRF completion guidelines Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required) SAE reconciliation Electronic data

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