Director, Clinical Data Management

Company: Arrowhead Pharmaceuticals, Inc.
Location: Pasadena
Posted on: May 5, 2020

Job Description:

Arrowhead seeks an experienced clinical data management leader to join its clinical development team.-- The Director of Data Management is responsible for providing expertise and operational leadership of the clinical data management (CDM) function of CDM activities for all clinical trials. --ResponsibilitiesServe as the interdepartmental subject matter expert for the CDM area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance;Evaluate, recommend, implement and lead processes, infrastructure development and staffing to build Arrowhead's CDM function for its growing clinical pipeline, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards;Interface with internal stakeholders including regulatory affairs, program management, and R&D to assess and meet data management needs; represent CDM function in project team activities and meetings;Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data;Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission;Generate data listings or other data review tools for reporting of study metrics;Evaluate and select CDM vendors; lead vendor activities for clinical trial data collection to ensure quality and timely deployment;Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc;Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives; develops SOP as needed;Other related duties, as assigned.Requirements:Bachelor's--degree--or--Master's--degree--in a related field6+--years--of supervisory and management experience10+--years--of clinical data management experienceStrong understanding of the clinical data management process including CDASH and SDTM data formats, and familiarity with physiology, pharmacology, clinical study objectives and methodologies.Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock proceduresExpert knowledge of industry leading eCRF toolsGood understanding of database and dictionary structures (e.g., MedDRA)Good Clinical Data Management Practices (GCDMP) understandingGood Clinical Practices ICH GCP guidelines understandingAbility to travel domestically and internationally up to 10%Preferred:Certified Clinical Data Manager (CCDM)Experience managing contract and/or permanent CDM staff membersProject management experience in a team setting within the biotech/pharmaceutical industryGlobal trial expertiseSAS and PL/SQL, as well as other relevant programsDemonstrated experience preparing and managing project budgets and timelineExperienced in a senior clinical data management role within a CRO

Keywords: Arrowhead Pharmaceuticals, Inc., Pasadena , Director, Clinical Data Management, Executive , Pasadena, California