Principal Clinical Data Manager at Alexion Pharmaceuticals, Inc.
Posted in Professional Services 13 days ago.
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Location: Boston, MassachusettsJob Description:
Alexion Pharmaceuticals, Inc.
Alexion is an Equal Opportunity/Affirmative Action Employer.
Req ID: 11641
Job Category: Biostatistics, Clinical Data Management, & Programming
Location: Boston, MA
Posting Date: February 7, 2018
Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal. Note that you will need to be connected to the VPN if you are applying away from the office.
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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.
- 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 plan (DMP).
- 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.
- 8-12 years' experience in Clinical Data Management or equivalent.
- 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.
- Requires a Bachelor's degree in a scientific discipline or equivalent. A Master's degree in a related science field is preferred.
Boston, MA, United States
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
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