Clinical Trial Manager Job at Scientific Search, Morristown, NJ

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  • Scientific Search
  • Morristown, NJ

Job Description

Location: Morristown, NJ/Hybrid

Base Salary up to $150k plus bonus and LTI.

Our biopharmaceutical client located in Northern NJ area has tasked Scientific Search with finding a Clinical Trial Manager. This role is responsible for supporting study management activities for clinical studies in compliance with Standard Operating Procedures (SOPs), ICH-GCP, clinical study protocol and all applicable regulatory requirements.

Responsibilities

  • Ensures that study conduct is in accordance with the study protocol, Good Clinical Practices, and Standard Operating Procedures, and regulatory authorities, as applicable
  • Manages all day-to-day communications and tasks with internal team, vendors and investigational sites. Oversees site start-up, subject recruitment, enrolment, study management, monitoring, site management, trial master file, and data clean up
  • Attends, contributes and may lead cross-functional team meetings, Investigator Meeting, conferences and events
  • Review and contributes to protocol development, Informed Consent Form, eCase Report Forms, and any additional study documents for study conduct
  • Participate in vendor selection, assists with review of contracts and negotiation of study budgets. Also participate in review of site budget and contracts.
  • Conducts site management (e.g. device accountability, Investigator credentialing, and research staff training) including Sponsor Oversight Visits. Review monitoring reports.
  • Participate in the preparation and follow-up/resolution of regulatory authority inspections as well as internal audits, site audits and other quality audits.
  • Assists and/or manage activities and interactions with contractors, CROs, and/or vendors
  • May perform on-site monitoring, audit and verify data entered on eCRFs are complete accurate and consistent with source data. Generate MVRs after each visit.
  • Maintains all relevant documentation and communications as part of study files including review of TMF for completeness
  • Review and contribute to CSR development

Requirements

  • Bachelor’s degree or equivalent required in science/health preferred
  • Minimum 5+ years clinical operations/study management experience including site monitoring (knowledge of audit preparation and sponsor oversight monitoring a plus)
  • Experience in managing CROs and other vendors
  • Experience in clinical trial electronic systems such as eDC,TMF and CTMS
  • Working knowledge of ICH GCP guidelines and essential documents and TMF

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.

Job Tags

For contractors,

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