Clinical Study Lead Manager

4 days ago


Basking Ridge, New Jersey, United States Proclinical Staffing Full time
Senior Manager, Clinical Study Lead

Proclinical is seeking a Senior Manager, Clinical Study Lead to oversee and manage clinical study operations.

Key Responsibilities:
  • Develop and manage study-specific documentation, ensuring compliance with regulatory requirements.
  • Supervise the setup and maintenance of study systems, including CTMS and TMF.
  • Ensure compliance with clinical trial registry requirements and manage study budgets, timelines, and results.
  • Lead risk assessments and develop mitigation strategies, conduct feasibility assessments, and select study regions and countries.
  • Oversee site evaluation, selection, and investigator meetings, monitor site activation and visits, and address any deviations.
  • Develop and implement patient recruitment and retention strategies, oversee study drug and clinical supplies forecasting and accountability, and ensure data quality through regular review of metrics and listings.
  • Maintain audit and inspection readiness throughout the study lifecycle.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.



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