CLINICAL DATA MANAGER 2 [SB]188430

Job Description

 

Position Title: Clinical Data Manager II

The Clinical Data Manager II (CDM) oversees the studies to drive innovative database building, data collection, tracking and review solutions from complex, diverse sources to ensure timely delivery of high-quality data in a regulated and changing global clinical trial environment.

The role involves interfacing with statisticians, clinical affairs representatives, and external partners and vendors to design, configure, and test the clinical database systems. The CDM II will also be involved in troubleshooting any issues on behalf of the end users and maintaining data standards.

 

The position will report to the Director of Data Management within Medical, Biostatistical and Design Quality (MBDQ).

 

Duties & Responsibilities:

  • Leads the development and implementation of innovative strategies and technologies for database design

  • Collaborates with Clinical Affairs team to understand changes and help develop data and technology strategies to support those business strategies

  • Participates in the review of Clinical research documents (e.g., Protocols, Case Report Forms, and Statistical Analysis Plans)

  • Develops and maintains the Data Management Plan (DMP) throughout the lifecycle of study project and ensures that the DMP is followed according to study design and requirements

  • Develops electronic Case Report Form (CRF)

  • Develops database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations

  • Works with Database Engineer to create the EDC database specification

  • Conducts the User Acceptance Testing (UAT) of the database prior to moving study to production

  • Creates the eCRF Completion Guidelines

  • Responsible for database lock/unlock/relock activities

  • Creates data listings for data management review purposes, summary table validation and data specifications for data management audit(s) as applicable

  • Coordinates the archiving of study databases and related documents

  • Performs close-out audit, as specified, for closing of study trial in EDC or other clinical data management databases

  • Participates in conference calls and/or meetings with study team

  • Adheres to data management SOPs and work instructions

  • Assist in defining and/or creating data listings for data management review purposes, summary table validation, and data specifications for data management audit

  • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management database(s)

  • Represents DM function at project team meetings. Contributes to departmental process improvement initiatives

 

Required Knowledge/Skills, Education, and Experience:

  • Master’s degree in a science related field

  • At least eight (8) years data management and/or related work experience in a medical device or pharmaceutical industry/company

  • Working knowledge within areas of Good Clinical Practices, Good Clinical Data Management Practices, Design and Conduct of Clinical Trials/Studies, and related regulatory requirements and terminology

  • Experience working within a Clinical EDC system (e.g., Oracle Clinical, Medrio, Medidata Rave)

  • Exposure to clinical data coding classification systems, e.g., MedDRA, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository

  • Programming knowledge of SAS, R, &/or SQL is desired

  • Strong interpersonal, organizational, and communication skills

  • Excellent attention to detail and problem-solving skills

  • Ability to work effectively work in a team setting


Job ID: 188430

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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