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Pre IPO Biotech Looking for a Clinical Data Manager

This Jobot Job is hosted by: Victoria Casal
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $130,000 per year

A bit about us:

A Pre IPO biopharmaceutical company with the aim to improve the lives of cancer patients by discovering and developing innovative medicines to fight advanced tumors. We are a fast growing organization looking for people who want to grow in their careers and help others!

Why join us?

Competitive salary
15-20% yearly bonus
Medical/Dental/Vision benefits
Stock Options
Fully Remote

Job Details
  • Oversight of all data management activities and deliverables on assigned clinical studies
  • Manage and oversee CROs handling clinical data, including managing their timelines and budgets
  • Work with CROs and Medical Monitors to coordinate activities for the medical review of clinical trial data
  • Work with biostatistician and SAS programmers to ensure CDISC data standards (CDASH/SDTM) are implemented
  • Provide review and oversight of database design, UAT, and deployment to ensure quality and efficiencies through data and process standardization
  • Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews), and provide feedback to CRO
  • Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
  • Lead interactions between internal and external data vendors on the collection, transmittal, and transfer of clinical trial data; support review and reconciliation of external data; coordinates/leads SAE reconciliation
  • Review clinical study protocols and statistical analysis plans and ensure data quality for data analyses
  • Ensure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines, as they pertain to data management activities
  • Manage competing data management priorities across multiple studies
  • Work independently, exercise appropriate judgment, and coach other team members for effective communication
  • Assessment of data management vendors
  • Assist in the compilation of clinical data for regulatory submissions
  • Previous experience in the management of budgets
  • In-depth knowledge of all aspects of data collection and query resolution in clinical studies
  • Knowledge of EDC systems
  • Demonstrated capabilities and proven track record of problem-solving skills
  • Excellent communication skills (oral and written) and interpersonal skills
  • Highly motivated team player willing to work and collaborate cross-functionally

Job Requirements and Education:
  • Bachelor’s degree in data management or related field of study preferred
  • Oncology therapeutic area experience preferred
  • Minimum of 5 years data management (with Bachelor’s degree) or 6 years data management (without Bachelor’s degree) experience in the pharmaceutical/biotech/CRO industry
  • Direct experience in oversight of data management vendors

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Job country: United States

City: Atlanta

Category: Clinical Data Managers

Location: Atlanta, GA, United States

Job posted 2022-06-04

This job is expired

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