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Lead Clinical Data Manager

1 hour, 5 minutes ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Orca Bio

Orca Bio

Orca Bio is revolutionizing allogeneic cell therapy with next-gen therapies for better outcomes and fewer risks, transforming lives through precision and innovation.

Pharmaceuticals
51-250
Founded 2016
$192M raised
View All Jobs 5

Description

  • Own all aspects of clinical trial data management from study start-up through database lock and study close.
  • Build and test EDC systems, including user acceptance testing (UAT).
  • Develop and maintain data management documentation, including CRFs, data management plans, edit check specifications, data review plans, and data transfer agreements.
  • Design case report forms (CRFs) for electronic data capture (EDC) systems.
  • Perform data cleaning, discrepancy management, and query resolution activities.
  • Conduct data validation checks and implement quality control measures to ensure data accuracy and completeness.
  • Collaborate with study team members to resolve data-related issues and discrepancies.
  • Generate and review data listings, summaries, and reports for data review.
  • Serve as a primary or backup resource for data management issues.
  • Ensure compliance with GCP, CDISC standards, and other applicable regulations.
  • Contribute to the development and validation of data management software tools.

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 industry, preferably in a smaller biotech sponsor environment.
  • Strong expertise in project or program management, including stakeholder management.
  • Knowledge of industry standards including CDISC, SDTM, and CDASH.
  • In-depth understanding of regulatory guidelines including ICH, GCDMP, and 21 CFR Part 11.
  • Proven ability to identify data and system issues early and mitigate risks to data quality.
  • Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
  • Experience developing and implementing 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 annual salary based on experience, education, location, and market factors.
  • Pre-IPO equity and annual bonus for full-time employees.
  • Medical, dental, and vision benefits.
  • PTO and a 401(k) plan.
  • Life insurance and accidental death and disability coverage.
  • Parental leave benefits.
  • Subsidized daily lunches and snacks at on-site locations.

Interested in this position?

Apply directly on the company website

Apply Now

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