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Orca

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Lead Clinical Data Manager

Location

United States

Posted

8 days ago

Salary

0

Seniority

Senior

Postgraduate Degree5 yrs expEnglish

Job Description

Lead Clinical Data Manager

Orca

• Responsible for all aspects of clinical trial data management from study start up through database lock and study close. • Ensures optimized data collection, flow and access across EDC and non-EDC data sources. • Ensures accuracy, consistency, completeness and CDISC compliance of all clinical databases. • Operate as a key member of the Clinical Operations team.

Job Requirements

  • BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.
  • 5-7+ years of data management experience in the pharmaceutical or biotechnology industries, preferably in smaller biotech sponsor environment.
  • Strong expertise in project/program management including stakeholder management.
  • Knowledge of industry standards (CDISC, SDTM, CDASH).
  • In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
  • Proven ability to preemptively identify data and system issues and mitigate risks to data quality.
  • Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
  • Experience in development and implementation of Clinical data management standards and procedures.
  • Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
  • Prior experience with Zelta by Merative (formerly IBM) CDM platform preferred.

Benefits

  • Competitive medical, dental, and vision benefits
  • PTO
  • 401(k) plan
  • Life and accidental death and disability coverage
  • Parental leave benefits
  • Subsidized daily lunches and snacks at on-site locations
  • Annual bonus
  • Pre-IPO equity

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