Clinical Study Management

  • location: Northbrook, IL
  • type: Contract
  • salary: $68 - $77 per hour

job description

Clinical Study Management

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Job Title: Clinical Study Manager

Position Description

  • Responsible for overall study and vendor management.
  • Responsible for study document preparation, processing and review.
  • Responsible for budget review and management.
  • Provides direction on site selection and management.
Position Responsibilities

  • Project Management: Manages clinical studies to ensure completion per established R&D goals and objectives. Manages the day-to-day operations of assigned studies. Manages cross-functional teams and coordinates internal resources (i.e., Clinical Studies, Data Management, Biostatistics, Technical Services, PSP). Monitors patient enrollment, patient evaluability and overall study site performance. Reviews and monitors safety of product. Proactively identifies and resolves issues that arise during study conduct; manages escalation of study-related issues. Provides direction and substantive input into data reviews. Responsible for assuring the quality of key study team deliverables such as the monitoring plan, study protocol and CRF data. Involved in data reviews and preparation of statistical analysis plans and clinical study reports. Responsible for the conduct of investigator meetings and CRA meetings; assists in the planning and preparation of expert meetings. Coordinates therapeutic area and other relevant training for internal and external project team members.
  • Document Preparation, Processing and Review: Responsible for the preparation of study protocols. Provides substantive input into the preparation of clinical study reports and relevant sections of pre-IND briefing documents, INDs, NDAs, and other documents intended for regulatory submission. Provides substantive input into the review and preparation of CRFs, data preparation plan, statistical analysis plan and other study-related materials.
  • Vendor Management: Works with the Outsourcing Department to define project scope. Drives the selection and ongoing management of vendors, including CROs, central laboratories, core ECG readers, patient recruitment vendors, etc. Works closely with CRO management in overseeing CRO staff in their study conduct including study implementation, study management, data management and training. Ensures quality and timeliness of data analysis and transfer.
  • Budget Review and Management: Responsible for development and review of assigned study budgets, including site and vendor budgets; actively monitors study expenditures and payments; prepares accurate quarterly budget forecasts. Reviews and approves study site payments and vendor payments, as appropriate.
  • Site Evaluation: Provides input in making site selection decisions; assesses overall site quality on an on-going basis; helps resolve site problems; supports CRAs, Sr. CRAs and Assoc. Clinical Study Managers on site-related issues.
Position Requirements

  • University/College Degree with at least five years clinical trials experience is desired.
  • Working knowledge of ICH and GCP guidelines is required. Must have knowledge of protocol and clinical drug development process, clinical study design, planning and management, and monitoring experience.
  • Requires proven time and project management skills with proven leadership ability. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Travel required.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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