Clinical Data Manager

eClinical Solutions

Mansfield, MA, US
  • Job Type: Full-Time
  • Function: IT
  • Post Date: 04/23/2021
  • Website: eclinicalsol.com
  • Company Address: 603 West Street , Mansfield, MA, 02048

About eClinical Solutions

eClinical Solutions seamlessly orchestrates clinical technology and expertise to help accelerate the clinical development process.

Job Description

We're a specialized clinical data services and software company with remote-based opportunities for experienced data managers. 

 

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

 

Clinical Data Manager

 

Clinical Data Managers are responsible for providing quality Data Management deliverables for clients.   Clinical Data Managers will also assist EDC Developers in performing the configuration activities of the EDC project and perform activities associated with the project requirements and data. Additionally they will perform Quality Control of configured projects for other team members for those activities that they did not perform the development / configuration. 

 

This position reports to a management position of the Professional Services Team at Company’s Head Office in Mansfield, MA. The Company offers highly competitive compensation package including competitive salaries, 401(k) program, subsidized health and dental insurance, paid vacation and sick time, short term and long term disability insurance, life insurance, monthly wellness/massages, flexible work environment, company outings and more.

 

 Responsibilities

 

 Provide EDC Services for projects including Protocol Conversion, Database Build, eCRF design, Edit Checks design and related EDC components

 

Provide Data Management Services for projects including Data Verification, Data Review, Query Management, Coding, External Data Reconciliation, SAE Reconciliation and related tasks

 

Collaborate with the project team to ensure the deliverables are completed on time with high quality

 

Provide Quality Control on deliverables developed by other team members including JReview Report specifications and Clinical Data Repository (CDR) deliverables

 

Maintain or provide input to all required Study Documents including Data Validation Specifications, Data Management Plan…etc. as required by SOP and Processes

 

Work on consulting efforts related to systems including UAT, global library/standards development, implementation of Client CDRs

 

Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines and procedures

 

Other duties as assigned

 

Candidate Profile

 

  • Basic Science/Bachelor of Science degree (Master in Science preferred) in health related field
  • Excellent knowledge of English
  • Minimum 2-4 years in Pharmaceutical/Biotechnology industry or equivalent consulting role
  • Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
  • Experience performing data management activities, EDC experience a plus
  • Excellent verbal and written communication skills
  • Detail oriented, ability to multitask with strong prioritization, planning and organization skills
  • Proficiency in Microsoft Office Applications
  • Strong familiarity with EDC and Clinical Data Management Systems: Rave,  InForm, Clintrial, or Oracle Clinical preferred
  • Experience with Data Reporting Tools: Business Objects, JReview, Cognos or related preferred

 

  We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based  qualifications, merit, culture fit and business need.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.