Manager, Clinical Research

NS Pharma
Any Location, NJ
Job Description
This is an individual contributor role that supports the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, local Regulatory requirements and NS Pharma standard operating procedures.

Requirements

  • Assist in the planning, implementation and management of assigned regional or global clinical studies.
  • Facilitate CRO./vendor selection process.
  • Maintain oversight of assigned study vendors (e.g. central labs).
  • Perform assigned activities in the selection of clinical sites.
  • Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs.
  • Review site visit reports, identify issues and ensure issues are resolved.
  • Oversight of patient recruitment and development of recruitment strategies and plans.
  • Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics.
  • Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned.
  • Tracking of clinical data, regulatory documents, and patient
  • Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements.
  • Facilitate internal review of clinical trial agreements and ancillary agreements
  • Implement and maintain study-specific training program.
  • TMF oversight review during study conduct and TMF management during study closeout.
  • Support creating and maintaining clinical SOPs as part of global QMS.
  • Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations).
  • Perform other tasks and functions as needed.

Benefits

  • Medical, Dental & Vision Insurance
  • Basic and Voluntary Life and AD&D Insurance
  • Short- and Long-Term Disability Insurance
  • Flexible Spending Account
  • Health Savings Account
  • Employee Assistance Programs
  • Discretionary Bonus Programs and Long-term Incentive Plan
  • Retirement Savings 401k with company match
  • Generous Paid Time Off
  • Sick Time & Paid Holidays
  • Paid Year-End Shutdown
  • Career Development, Progression and Training
  • Flexible Work Arrangement Programs
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