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Clinical Database Specialist

Description:

McKesson is in the
business of better health and we touch the lives of patients in virtually every
aspect of healthcare. At McKesson Specialty Health, our products and services
span the full continuum of specialty patient care. From the initial phases of a
product life cycle and the distribution of specialty drugs, to fully integrated
healthcare technology systems, practice management support, and ultimately to
patient care in the communities where they live, we empower the community
patient care delivery system by helping community practices advance the
science, technology and quality of care.
We have a vision ?that the long-term vibrancy of community care will be
achieved through the leadership of physicians committed to clinical excellence
and innovation, enabled by close collaboration with our organization and our
deep clinical, operational and technological expertise. Every single McKesson
employee contributes to our mission?by joining McKesson Specialty Health you
act as a catalyst in a chain of events that helps millions of people all over
the globe. You?ll collaborate on the products and solutions that help us carry
out our mission to improve lives and advance healthcare. Working here is your
opportunity to shape an industry that?s vital to us all.
Join our team of leaders to begin a rewarding career.
Current Need
Position Description
Takes business needs/wants & translates those needs into measurable
requirements that can be coded, tested, & successfully implemented &
adopted for products/applications\: -Partners with stakeholders to create
specifications & identify business requirements for systems & solutions
to meet business needs -Defines, analyzes & proposes business solutions
based on the business needs -May review/validate test plans, ensuring that the
end result meets the specified business requirements -Supports QA activities as
needed -Collaborates with technical delivery & solution engineering teams
on the details of technical solutions to validate that the strategic business
needs are met -Validates & ensures that the proposed solution meets the
stakeholders? needs -May lead cross-functional integrated teams to address
business & adoption issues (e.g., user experience, data flow, process flow)
-May participate in the development process or other steps of the product
lifecycle -Serves as a key resource by providing input into the development of
new feature/release education -Collaborates with regulatory SMEs to understand
how regulation affects products & documents regulatory requirements -Conducts
completed business requirements review with stakeholders & documents the
acceptance of those requirements
?
Responsibilities\:
Coordinate eCRF
development and maintenance across research projects for consistencyParticipates in the review
of clinical research documents (eg. Protocols, Reports and Statistical
analysis).Provide eCRF design
analysis and recommendations to ensure best practices are institutedApply expertise in the
software tools that the company is using to create eCRFs and collaborate
on training for end-users with software vendor. The eCRF components will
include forms, dictionaries, edit checks, database, reports, logic and
custom functionsDevelops Data Management
Plan (DMP), maintains DMP throughout lifecycle of study project and ensures
DMP is followed according to study design and requirementsImplement eCRF design and
edit specifications, including derivations for all assigned studies.
Ensure they are complete and comprehensive and include custom functions
prior to building the eCRFDevelop study level eCRFs,
including programming the edits including simple custom functionsFollow all eCRF
development SOPsProvide feedback on
standards of performance once deployedEnsure that all eCRF
testing is completed and documentedMaintain assigned eCRFs,
including making updates to active eCRFs and ensuring that all updates are
fully tested before eCRF is launchedProvide study specific
eCRF training when assignedSolve eCRF design issues
for assigned studiesArchive eCRFs as defined
by SOPsAbide by all HIPAA and
associated patient confidentiality requirements.

Qualification:

Minimum
Requirements
2+ years experience in business analysis,
requirements definition and deployment of business requirements to information
systems.
Critical Skills
2+ years of experience
creating databases and eCRFs, data entry and eCRF data review within a
biotech, pharmaceutical or CRO environmentExperience in eCRF design
and deploymentDeep
understanding of data management processes?in a clinical research
settingExperience in clinical data
management and eCRF software (OpenClinica, RAVE, etc.)A good working
knowledge of clinical and scientific terminology used within a
biopharmaceutical setting, as well as ICH guidelines and cGCP
regulations?Excellent organizational,
written and communication skillsAdvanced knowledge of MS
Excel, Word, PowerPoint, and AccessSound knowledge of MS Access
and MS VisioExcellent ability to
manipulate dataWorking understanding of
DBMS software (e.g., Oracle, SQL Server)Experience writing DBMS
queries (e.g., SQL) & scripting languages, procedural programming
languages (e.g., PL-SQL, T-SQL, java)Knowledge of performance
monitoring & tuning of queries and how data base objects are utilized.Basic knowledge of HTML5,
CSS3, Java, JQuery, AJAX, RegExp.ETL extract, transform and
load operations may be a part of data cleansing and staging of data for
clinical testing environments.SAS/SQL/mySQL
?
Education
4-year degree in?in Life Sciences,
Information Systems, Computer Science?or related field or equivalent
experience
Physical Requirements
General Office Demands
Benefits & Company StatementMcKesson believes superior performance ? individual and team ? that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it?s flexible enough to meet the different needs of our diverse employee population.We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.But we can?t do it without you. Every single McKesson employee contributes to our mission?whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company?and of healthcare. At McKesson, you?ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that?s vital to us all.McKesson is an equal opportunity and affirmative action employer ? minorities/females/veterans/persons with disabilities.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.Agency StatementNo agencies please.



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