Remote Senior Clinical Data Manager - Lead Data Integrity

Placements24

Queenstown (MD)

Hybrid

USD 120,000 - 170,000

Full time

34 hours ago
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Benefits offered by this job

Competitive salary
Health insurance
Retirement planning
Annual bonuses
Remote work autonomy

Job summary

Placements24 is seeking a Senior Clinical Data Manager to join a fully remote data management team. You will oversee data management activities, create DMPs, and lead data review processes to support regulatory submissions.

The ideal candidate will have extensive experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva), strong CDISC SDTM/ADaM knowledge, and excellent communication skills, enabling collaboration across regulatory affairs, biostatistics, and programming teams.

Qualifications

  • Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences).
  • Minimum of 5 years of experience in clinical data management within pharma/biotech.
  • Proven expertise in designing and managing EDC systems (Medidata Rave, Oracle Clinical, Veeva).
  • Thorough understanding of clinical trial processes, data standards (CDISC SDTM/ADaM), regulatory guidelines.

Responsibilities

  • Lead the design, development, and execution of DMPs for assigned clinical trials.
  • Oversee setup and maintenance of EDC systems and databases.
  • Develop database specifications, including edit checks and data validation rules.
  • Manage data cleaning activities, including query resolution and trend analysis.
  • Ensure compliance with FDA/EMA and CDISC standards.
  • Collaborate with clinical ops, biostatistics, programming, regulatory teams.
  • Perform QC on data management deliverables.
  • Develop and implement data management SOPs and practices.
  • Train and mentor junior data management staff.
  • Participate in database lock and prepare data for analysis.

Skills

SQL
EDC systems
Data management
CDISC SDTM/ADaM
Regulatory knowledge
Data quality
Remote work
Communication

Education

Bachelor's degree

Tools

Medidata Rave
Oracle Clinical
Veeva

Job description

Placements24 is seeking a Senior Clinical Data Manager to join a fully remote data management team. You will oversee data management activities, create DMPs, and lead data review processes to support regulatory submissions.

The ideal candidate will have extensive experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva), strong CDISC SDTM/ADaM knowledge, and excellent communication skills, enabling collaboration across regulatory affairs, biostatistics, and programming teams.

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