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Director, Clinical Data Management

Company: Neurana Pharmaceuticals, Inc.
Location: San Diego
Posted on: March 28, 2020

Job Description:

POSITION SUMMARY:Neurana Pharmaceuticals is expanding its Clinical Operations department to support the development of tolperisone to treat acute, painful muscle spasms.--Working directly with the company's Chief Medical Officer, the Director of Clinical Data Management will manage all aspects of Neurana's clinical data needs.--You will fully support data collection, analysis and reporting.----You will ensure that a robust communication plan, including status and timing of operational deliverables, is in place for all studies and programs. ESSENTIAL FUNCTIONS:Establish customer-service focused department to fully support data collection, analysis and reporting Proactively identify and assess new technologies Evaluate new technology and/or software for fitness of purposeLead implementation and roll out of systems in support of clinical data needsSupervise and support clinical data projects and teamsCollaborate with business owners of adjacent systems to build tools to explore and characterize dataEnsure that clinical and adjacent data systems and related processes are well-integrated, fully compliant and functionalProvide strategic input and technical expertise for clinical data management or adjacent data systems and participate in cross-functional project and portfolio team meetingsDevelop training and standards for clinical data systemsManage relationship with vendor and partner information technology teams in relation to clinical data systemsParticipate in vendor identification, selection and management of clinical and adjacent data servicesOversee vendors providing data collection, analysis and reporting services; ensure adherence to contractual obligations, including budgetProvide metrics for data projects and adjacent interface statusDevelop internal tools and dashboards to assess and explore current status of clinical data projectsIdentify and implement process improvement strategies--Establish near-term goals and long-range vision in implementation of current company objectives based upon principles of good clinical practice (GCP) and good automated manufacturing practice (GAMP) in data systems.Facilitate collection of stakeholder user requirements and translate into functional systems specification documentsScope and implement data exchange with vendors and partnersEXPERIENCE / QUALIFICATIONS:Qualified candidates must have a bachelor's degree from an accredited college or university12 years relevant industry experience is requiredExperience considered relevant includes clinical research utilizing Patient Reported Outcomes (PROs) in a biopharmaceutical company.--Time spent in academia may also be considered relevant (e.g. Data Coordinator)Understands, identifies, mitigates, and communicates risks at the operational levelExcellent self-management and organizational skills with the ability to independently manage workload, set priorities and adjust those priorities as required by business needsStrong problem-solving skills with the ability to anticipate and recognize systemic problems and determine best resolution planTechnical experience in implementation and oversight of clinical trial, medical and adjacent data systems (clinical databases, EDC platforms data analysis/reporting tools)Experience with business continuance planning for clinical and medical systems and dataExperience with data collection and storage methodologies and data mining techniquesExperience establishing quality data systemsWorking knowledge of GXP/ICH Guidelines including data submission requirements

Keywords: Neurana Pharmaceuticals, Inc., San Diego , Director, Clinical Data Management, Healthcare , San Diego, California

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