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2017-06-13 08:09:33
Job description:
Role:Clinical Data Management Analyst
Location:Wayne, PA
Position Overview:
Key Skills:
Clinical Data Management Analyst Location:Wayne, PA
2017-06-13 08:09:33
Job Type:
Full Time only
Budget $: 100,000 - 200,000
Budget $: 100,000 - 200,000
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.
- 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.
- 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.
Key Skills:
