Clinical Operations

  • location: Rockaway, NJ
  • type: Contract
  • salary: $63.25 - $69.25 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/296430

Senior Regional Site Manager

Job Summary

  • The Senior Regional Site Manager (Senior RSM) is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected.
  • The Senior RSM conducts all monitoring visits in accordance with Allergan standards.
  • The Senior RSM exercises responsibility across multiple projects and therapeutic areas.
  • The Senior RSM interfaces with clinical investigators, other site staff and Allergan personnel in order to carry out this responsibility.
  • The Senior RSM is completely accountable for site management and data quality for each assigned site. In addition, the Senior RSM may hold other assignments, such as Lead Site Manager, Global Site Management Operations Subject Matter Expert (SME), Contract Research Organization (CRO) Oversight Representative, or any other project assigned by Global Site Management Operations management.

Job Responsibilities

  • Conduct the following monitoring visits according to applicable Allergan SOPs, Working Documents, GCP/ICH guidelines, Protocol Specific Monitoring Plans, and departmental timelines as follows:

    - Site Qualification Visits (SQVs)

    - Site Initiation Visits (SIVs)

    - Interim Monitoring Visits (IMVs)

    - Remote Monitoring Visits (RMVs)

    - Close-out Visits (COVs)

  • Manage all site activities for assigned sites including:

    - Partnering with sites to ensure recruitment goals are met.

    - Assisting sites with operational needs (e.g. vendor activities, site payment).

    - Primary contact for all issues that arise with sites.

  • Communicate site status and monitoring activities, as follows:

    - Submit monitoring visit reports (MVRs) for all monitoring visits conducted.

    - Send follow-up letter to Principal Investigator summarizing visit conduct and all action items.

    - Contact the Regional Operations Manager (ROM) and Project Lead (PL) regarding significant site conduct issues.

    - Complete GXP Compliance audit responses in conjunction with ROM and PL.

  • Meet all departmental timelines and deliverables for the following activities:

    - Submission of MVRs in CTMS.

    - Submission of MVRs to the TMF.

    - Freezing of all electronic case report forms.

    - Retrieval of all paper case report forms (if applicable).

    - Maintenance of calendar.

    - Submission of weekly time and expense reports.

Education & Qualifications

  • Allied Health Professions degree (PA, RN, RPh), relevant clinical experience or four-year life science degree.
  • Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization (5 years preferred)
  • Experience working in more than one therapeutic area
  • Familiar with Electronic Data Capture preferred
  • Experience with Risk Based Monitoring preferred

Benefits

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

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