Kloudhire

Clinical Data Management Analyst Location:Wayne, PA

Posted on : 09-08-2023
Job Type : Full Time only
Salary : 100,000 - 200,000

Job Description:

Job description:
Role:Clinical Data Management Analyst
Location:Wayne, PA
Position Overview:

The Programming Data Management Analyst supports the implementation of products and services to meet customers needs.
Working with eCOA Clinical Data Management to support Sponsors and internal teams such as Client Services,
Clinical and Technical Delivery,
this position implements assigned programming/analytical tasks,
unit testing, and documents their work according to accepted quality principles and supports testing.

Essential Duties and Responsibilities:

Note: Other duties may be assigned.Configuration and DevelopmentOverall responsibility for the design, development and on time delivery of project specific configurations and customizations.
Work directly with the external and internal clients to prepare, adapt, or agree on all specifications provided.
Working with the external and internal clients, gains an understanding of design patterns, principles and standards to be followed in implementing assigned tasks.
Recommend, design and implement on-going application and architectural improvements.
Creates and documents system design specifications and other technical documents as required.
Understands and follows all coding standards.
Creates robust, well documented code.
Creates database objects as required.
Completes unit testing and peer review documentation as required.
Integrates implemented code and database objects into release application.
Supports all phases of testing by efficiently diagnosing and resolving defects.
Support test script development and performance of user acceptance testing.
Participate in all post live study changes including risk assessment, specifications, testing, and interactions with study team for shared activities.
Other project work as assigned.
May provide after hours application support as required.
Application SupportEfficiently and effectively diagnoses and resolves defects.
Identifies areas where applications are impacting the underline data and works with BSA and/or Software Test Engineer to define test cases required to determine impact to data.
Completes all required change control documentation including updates to requirements, design and other technical documents as required.
Deploys resolution to testing and production environment as required.
Consults with Product Innovation team or other on defects that impact core productQuality System ResponsibilitiesPerforms all work in accordance with documented Standard Operating Procedures (SOPs),
Working Instructions and Best Practices.Adheres to Good Clinical Practices (GCP), 21 CFR Part 11 and other regulatory requirements as required.
Skills & CompetenciesEducation
Bachelors Degree in Computer Science, or related fieldDemonstrated experience will be considered in lieu of a Bachelors Degree.
ExperienceTwo (2) to four (4) years of experience professionally programming.

Experience with some or all of the following technologies:

Microsoft SQL Server2008/2012 MySQL or other relational databases including stored procedures,
views and triggersMicrosoft SQL Server Reporting Services or other reporting toolWrites and executes planned and ad-hoc SQL or SAS queries against MS SQL Database to extract data for Data Transfers and Reports.
Creates and executes Data Change Guides (DCGs) and determines corresponding risk/impact assessments.
Provides Data Transfers/Reports per approved Data Transfer Specifications.
Reviews, provides feedback and approves Data Transfer Plans and final Data Change Form documents submitted to clients.Creates stored procedures to manipulate data for data-driven changes to IVR system functionality.
Creates DTS packages for imports into study databases.
Participates in special data-related projects as needed.
Team Foundation Server, Visual Source Safe, Subversion or other source control productExperience developing, enhancing and customizing configurable applications is desirable.
Domain experience in any of the following is desirable:Mobile device applications include Smartphone and TabletElectronic Data Capture applicationsClinical Trial Management SystemsExperience estimating development and support tasks.
Familiarity with 21 CFR Part 11 or experience in a regulated environment desirable.
Competencies & Personal AttributesStrong verbal and written communication skills.
Ability to complete high quality technical documentation.
Ability to quickly learn and apply new skills, procedures and approaches.
Ability to meet established timelines.Ability to work in a fast paced environment.
Ability to multi-task and effectively handle changing priorities.
Ability to work in a team environment;
establish and maintain effective work relationships with co-workers within and across functional areas.
Demonstrate extreme attention to detail and organization in all aspects of work.