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Associate Director, Clinical Data Management

Employer
Corcept Therapeutics
Location
Menlo Park, California
Start date
Dec 1, 2021

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Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
Job Description

Ensures optimized data collection, flow and access across EDC and non-EDC data sources.  Responsible for accuracy, completeness and CDISC compliance of Corcept clinical databases.

Responsibilities
  • Works in cooperation with Senior Director of Biometrics to select and maintain preferred vendor network for Biometrics
  • Reviews, proposes and obtains bids for tools enabling real-time data visualization, interrogation and reporting
  • Manages strategic input into the design of data flow across EDC and non-EDC data sources across vendor network
  • Manages data management service providers to ensure the quality of deliverables and that timelines are met
  • Develops and   contributes to design of processes enabling near-real time data access for Corcept clinical trials
  • Ensure data quality of clinical database through implementation of CDISC compliance
  • Reviews and critically assesses data query resolution metrics and suggests process improvement
  • Reviews study protocols to ensure that data collection and CRF design meet study objectives
  • Manages and oversees SAE reconciliation between clinical and pharmacovigilance database
  • Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
  • Provide subject matter expertise to project team members during all phases of project life cycle.
  • Provides accurate and timely clinical data to internal and external customers upon request.
  • Manage development, test and maintain data management systems.
  • Manage development and periodic review of Data Management specific SOPs, WIs and templates
  • Provide subject matter expertise prior, during and post internal and external audits and inspections.Maintain compliance with company and study-specific learning requirements.
Preferred Education and Experience
  • B.Sc/B.A or higher in science, math or computer science
  • 12+ year experience in clinical trial industry (med device, pharma or biotech)
  • 10+ year experience in data management in clinical trial industry (med device, pharma or biotech)
  • Experience in IT-related field a plus
  • Experience with Endocrinology clinical trials and CDISC therapeutic area standards a plus
  • Experience with management of data flow and curation of biomarker data a plus
  • Experience managing Data Management CROs
  • Direct report management and oversight a plus
Preferred Skills, Qualifications, or Technical Proficiencies
  • Master’s Degree in health care or life sciences preferred
  • Relational database experience, SQL, SAS, and clinical data management systems
  • Knowledge and experience with MedDRA, WHODrug and other Thesaurus classification of controlled management systems
  • Knowledge of CDISC/SDTM. Hands-on experience preferred
  • Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio, Inform)
  • Familiarity with Data Visualization Tools for quick customized data access (e.g Spotfire, Tablo, RShiny) a plus
  • In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
  • Demonstrated strong management abilities for project and staff management of Data Management Deliverables in clinical development

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