Clinical Data Manager III
Company: Alexion Pharmaceuticals
Location: Boston
Posted on: January 15, 2021
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Job Description:
Position Summary A Senior Clinical Data Manager (SCDM) has a
keen attention for detail and is responsible for providing
leadership or support for the start-up and execution of several
trials with a CRO or in-house to ensure data quality and integrity.
SCDMs will provide leadership or support for multiple, high volume
and extremely complex studies within a development program. The
individual will perform a variety of complex tasks to ensure
complete, accurate, high quality, and regulatory compliant data in
support of publications and regulatory submissions. Principal
ResponsibilitiesServe as lead CDM or assist the lead CDM on
assigned clinical trials by attending internal and external
clinical trial project team meetings. Responsible for providing
support for the study-specific data management tasks from protocol
review to database lock to ensure data are collected, reviewed, and
delivered with high quality, on-time, and within scope. Responsible
for the accurate development of CRFs, data entry screen
development, and edit specifications per protocol and the
completeness of user acceptance testing of CRFs and associated edit
specifications for 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).Provide
ongoing operational support for Medidata RAVE activities during
clinical trial conduct including development of clinical databases
and associated external data transfer documents including
import/export agreements and data specifications. 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 where protocol requirements are outside of standard CRF
library versions.Ensure that medical coding is completed in a
timely fashion, completed for all data cuts, and reviewed and
approved by medical monitors. Participate in the development of
standard operating procedures (SOPs).Mentor junior staff on
clinical data management activities and procedures. Provide
guidance to clinical data management personnel on assigned
projects, reviewing study documents as needed, e.g. Data Management
Plan, Operational Plan for database locksEnsure project
documentation is being archived in a timely manner into the Trial
Master File.Independently monitor own activities and project status
for successful project deliverables according to timelines.May lead
or participate in initiatives to streamline data management
processes.QualificationsExperience in clinical data management for
5years. Experience in vendor management of outsourced studies
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. Medidata Rave experience required. Medidata
Suite products (Safety Gateway, ePRO, RTSM) preferred.Experience
with CDASH terminology and/or MedDRA and WhoDrug medical coding
preferred.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.Education Requires a Bachelor---s degree in a
scientific discipline or equivalent. LIRM-1, 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.Alexion is a
global biopharmaceutical company focused on serving patients and
families affected by rare diseases and devastating conditions
through the discovery, development and commercialization of
life-changing medicines. As a leader in rare diseases for more than
25 years, Alexion has developed and commercializes two approved
complement inhibitors to treat patients with paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS),
as well as the first and only approved complement inhibitor to
treat anti-acetylcholine receptor (AchR) antibody-positive
generalized myasthenia gravis (gMG) and neuromyelitis optica
spectrum disorder (NMOSD). Alexion also has two highly innovative
enzyme replacement therapies for patients with life-threatening and
ultra-rare metabolic disorders, hypophosphatasia (HPP) and
lysosomal acid lipase deficiency (LAL-D) as well as the first and
only approved Factor Xa inhibitor reversal agent. In addition, the
company is developing several mid-to-late-stage therapies,
including a copper-binding agent for Wilson disease, an
anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G
(IgG)-mediated diseases and an oral Factor D inhibitor as well as
several early-stage therapies, including one for light chain (AL)
amyloidosis, a second oral Factor D inhibitor and a third
complement inhibitor. Alexion focuses its research efforts on novel
molecules and targets in the complement cascade and its development
efforts on the core therapeutic areas of hematology, nephrology,
neurology, metabolic disorders and cardiology. Headquartered in
Boston, Massachusetts, Alexion has offices around the globe and
serves patients in more than 50 countries. Further information
about Alexion can be found at: .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.Job ID: 24412Job Area: Clinical
OperationsFunction: Healthcare - OtherIndustry:
Pharmaceutical/Pharmacology
Keywords: Alexion Pharmaceuticals, Boston , Clinical Data Manager III, Executive , Boston, Massachusetts
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