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Clinical Data Manager I

Role overview

Qualifications

  • Experience in clinical data management
  • Knowledge of regulatory guidelines
  • Strong communication skills
  • Ability to collaborate within project teams

Responsibilities

  • Manage all data management deliverables for assigned studies
  • Ensure clinical trial databases meet project requirements
  • Review data and identify errors or inconsistencies
  • Perform study setup, specifications, and obtain approvals as needed

Key facts

Other skills

  • Collaboration
  • Detail Oriented
  • Organizational Skills

About the company

CALYX logo

CALYX

Calyx and Invicro are now Perceptive! Expanding on our combined 50-year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing. Perceptive’s offerings include imaging biomarkers and core lab services, as well as innovative technologies in randomization and trial supply management (RTSM), analytics, and software. Follow us at Perceptive Inc. and visit us at Perceptive.com

Company details

Company size1001 - 5000

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Job description

About Perceptive

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.

We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together.

Are you ready to help change the world?

Apart from job satisfaction, we can offer you:

HEALTH:
- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)

YOURSELF:
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings

WEALTH:
401(k) program, life & accident insurance and disability insurance

About the role

The Clinical Data Manager is responsible for delivery of an entire clinical trial. Is sponsor facing and works with study project managements and technical data management team to meet the design specs, monitor the health of the trial, ensure quality and data reconciliation.

Essential Functions:

  • Ensures clinical trial databases meet project requirements by:
  • Attending and participating in sponsor meetings
  • Managing all data management deliverables for assigned studies
  • Ensures the plan for data management is properly executed by:
  • Understanding the requirements for study implementation and data collection
  • Collaborating with project team to develop study-specific edit check criteria
  • Defining, running, and reviewing edit checks and resolving discrepant data
  • Maintaining organized, complete, and up-to-date study documentation
  • Performing study setup, specifications, and obtaining approvals as needed
  • Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
  • Keeping supervisor informed of project status
  • Ensures the accuracy and consistency of clinical databases by:
  • Reviewing data and identifying errors/inconsistencies
  • Collaborating with appropriate project team to resolve data issues
  • Tracking outstanding issues and following-up until resolution
  • Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
  • Other duties as assigned

This role is remote.  Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred.  The annual base salary range for this role is $52,520-$75,028. This range represents the anticipated initial annual salary and will vary depending on several factors including the candidate’s experience and skills as well as market rate adjustment.

Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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