Data Manager (EDC Systems – Clinical Research)

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profile Job Location:

Columbia, IN - USA

profile Monthly Salary: $ 50000 - 65000
Posted on: 8 days ago
Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Data Manager (EDC Systems Clinical Research)

Location:Remote

Department:PPD Evidera PCR Data Collection and Management

Job Summary:

We are looking for a motivated and detail-orientedData Managerto support the setup maintenance and quality assurance of data collected throughElectronic Data Capture (EDC) systemsin healthcare and clinical research studies. This entry-level position is ideal for candidates with academic or professional experience in clinical research health informatics or data science who are interested in building a career in clinical data management.

You will work closely with Senior Data Managers Clinical Operations and Research Teams to ensure accurate timely and compliant data capture and processing throughout the study lifecycle.

Key Responsibilities:

EDC System Support

  • Assist with the setup and configuration of electronic case report forms (eCRFs) in EDC platforms such asDFdiscover Dacima REDCap Medidata Rave etc.
  • Participate in user acceptance testing (UAT) and perform data entry tests to validate system functionality.
  • Monitor data entry progress and help resolve user-reported issues related to the EDC system.

Data Quality and Cleaning

  • Generate track and help resolve data queries in collaboration with study sites and clinical teams.
  • Perform ongoing review of collected data for completeness consistency and protocol compliance.
  • Assist in routine data cleaning activities and database freeze or lock procedures.

Documentation & Compliance

  • Maintain accurate documentation of data management activities including data validation plans CRF annotations and query logs.
  • Follow Good Clinical Practice (GCP) data protection regulations (e.g. GDPR HIPAA) and internal SOPs.

Collaboration & Training

  • Provide basic training and support to study staff and site users on how to use the EDC system.
  • Collaborate with clinical research coordinators statisticians and IT staff to support data workflows.

Required Qualifications:

  • Bachelors degree or equivalent work experience in Life Sciences Health Informatics Data Science Public Health or a related field.
  • Familiarity with EDC systems such asDFdiscover Dacima REDCap Medidata Rave etc. or similar tools.
  • Basic understanding of clinical research processes and terminology (e.g. protocol CRF AE SAE).
  • Proficiency in Microsoft Excel and basic data handling tools.
  • Strong attention to detail organizational and communication skills.
  • Ability to work independently and as part of a team in a fast-paced environment.

Preferred Qualifications:

  • 12 years of internship or work experience in clinical research data management or health data systems.
  • Understanding of data quality principles and regulatory requirements in clinical research (e.g. GCP 21 CFR Part 11).
  • Experience with other research platforms (e.g. Alchemer Forsta Qualtrics) is a plus.
  • Familiarity with data standards such as CDASH or SDTM is a plus.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Compensation and Benefits

The salary range estimated for this position based in District of Columbia is $50000.00$65000.00.

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

  • A choice of national medical and dental plans and a national vision plan including health incentive programs

  • Employee assistance and family support programs including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

  • Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

  • Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob Title: Data Manager (EDC Systems Clinical Research)Location:RemoteDepartment:PPD Evidera PCR Data Collection and ManagementJob Summary:We are looking for a motivated and detail-orientedData Managerto support the setup m...
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