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Senior Clinical Data Manager (Contractor) (Office or Remote)

Posted 13 weeks ago
Data Analysis
Contract
United States

Overview

The Senior Clinical Data Manager provides clinical data expertise to project teams in an outsourced and/or insourced Clinical Data Management model. The successful candidate will have advanced knowledge of end-to-end clinical research lifecycle and Clinical Data Management processes, as well as global regulatory, and industry rules and guidance (i.e. ICH, GCP) to support drug or biologics development.

In Short

  • Support all Data Management activities for assigned projects.
  • Act as Lead Data Manager or Support Data Manager on studies.
  • Participate on cross functional teams as the Data Management expert.
  • Lead Data Management start-up activities.
  • Ensure data meets analysis requirements.
  • Participate in data cleaning and review.
  • Review and contribute to study documents.
  • Maintain Data Management documentation.
  • Collaborate for data transfers and analytics.
  • Develop and revise SOPs and templates.

Requirements

  • Bachelor's Degree with at least 4 years’ experience in Clinical Data Management.
  • Excellent verbal and written communication skills.
  • Highly organized, collaborative, and detail-oriented.
  • Ability to prioritize and adapt in a fast-paced environment.
  • Experience with EDC systems, preferably Medidata.
  • Advanced knowledge of data collection and cleaning best practices.
  • Understanding of vendor management and data transfer workflows.
  • Knowledge of ICH, FDA, and GCP regulations.
  • No travel required.

Benefits

  • Equal Opportunity Employer.

A.B

Arcus Biosciences

Arcus Biosciences is a biotechnology company focused on developing innovative cancer therapies, particularly in the field of oncology and immunotherapy. The company emphasizes a collaborative and cross-functional approach to clinical development, aiming to drive the design, planning, and implementation of clinical trials for investigational products. With a commitment to scientific excellence and regulatory compliance, Arcus Biosciences fosters an inclusive work environment that values diversity and equal opportunity for all employees.

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