RemoteLeaf Logo
Log in Sign up

Lead Clinical Data Manager

4 weeks, 2 days 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 6

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

Similar Roles

Armada

Technical Program Manager (TPM)

Armada 201-500 information technology & services

Armada is hiring a remote Technical Program Manager to coordinate complex infrastructure and hardware programs across engineering, construction, operations, IT, and commercial teams.

Australia Full-time Lead Program Manager
$163k-$204k
Agile
6 hours, 39 minutes ago
Oscar

Analyst, Regulatory Affairs

Oscar 1K-5K Insurance

Oscar is hiring an Analyst, Regulatory Affairs to support the Evidence of Coverage team with regulatory filing coordination and related work for its health insurance operations.

United States Full-time Junior Compliance Manager Program Manager
$59k-$77k
6 hours, 39 minutes ago
Precision For Medicine

TMF Lead II (LATAM)

Precision For Medicine 1K-5K Pharmaceuticals

Precision Medicine Group is seeking an experienced Trial Master File Lead II to help establish a new LATAM regional function and maintain high-quality study TMFs across multiple clinical projects.

Mexico Brazil Full-time Mid Level Program Manager
6 hours, 39 minutes ago
Valtech

PXM Delivery Consultant

Valtech 5K-10K Professional Services

Valtech is hiring a PXM Business Consultant / Delivery Consultant in Canada to support retail and apparel clients by translating business needs into data models and deliverables for product experience management work.

Canada Full-time Senior Business Analyst Program Manager
$74k-$103k
Agile ERP SAP
6 hours, 54 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers