Associate Director, Clinical Data Management
Cheshire, Connecticut, Cambridge, Massachusetts
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 40 countries for the treatment of PNH, and in the United States for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
Performs a variety of extremely complex responsible tasks and to solve problems to define, enter, process, review, validate and maintain clinical trial data received in-house and remotely in order to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions. Activities are performed according to external regulatory requirements, and internal standard operating procedures (SOPs) and deadlines. The incumbent is responsible for preserving data integrity and adhering to deadlines in order to ensure accurate and on-time regulatory submissions and publications.
Serve as lead CDM on assigned clinical trials. Attend clinical trial project team meetings as lead CDM. Manage clinical trial and project database lock activities. Manage and monitor external vendors and clinical projects from start-up to completion according to project deadlines.
Manage the definition and user acceptance testing of programmed edit specifications and data review reports on assigned clinical trials.
Perform pre-, during, and post-data entry review of clinical data, identify data discrepancies and corresponding resolutions, and generate and manage queries on assigned clinical trials.
Develop, document, maintain and finalize the data management manual (DMM).
Develop, implement and maintain the global standard CDASH case report form library, code lists, and process documentation. Implement and maintain the CDASH eCRF standards in Medidata/RAVE.
Provide ongoing technical support of Medidata/RAVE during clinical trial conduct including development of clinical trials in EDC according to CDASH, provide ad-hoc report development, and support database lock and archiving activities.
Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies.
Manage centralized dictionary coding of clinical data to MedDRA and the World Health Organization Drug Dictionary. Generate and manage associated queries to identify and correct data issues to ensure accurate coding. Manage the creation and updating of standard dictionary coding guidelines and coding reports.
Develop standard operating procedures (SOPs) with CDM management.
Train peers on clinical data management activities and procedures.
Provide guidance to clinical data management personnel on assigned projects.
Set-up, maintain and archive electronic and hard-copy project documentation.
Independently monitor own activities and project status for successful project deliverables according to timelines.
Perform other additional tasks as requested by CDM management and personnel.
Demonstrate strong medical terminology skills.
Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
Proficient implementing and operating the EDC product Medidata/RAVE. Experience with Oracle Clinical/Inform a plus.
Proficient with: (a) CDASH, (b) dictionary coding with MedDRA and the World Health Organization Drug Dictionary (WHO-DD), (c) SAS for data review
Possess effective written and verbal communication skills, interact professionally with personnel at all levels within and external to the company, and be dependable and a team player.
Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be capable of working under deadlines.
Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines, and define tracking tools to manage projects.
Experience in solving extremely complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements.
Possess a thorough knowledge of Data Management SOPs and regulatory requirements, and be capable of providing guidance to and training peers.
Masters’ degree in a scientific discipline with a minimum of 8-12 years’ experience in Clinical Data Management or equivalent.
Drive for Results
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
Alexion Pharmaceuticals, Inc. (Alexion) is a biopharmaceutical company engaged in the discovery, development and delivery of biologic...