Senior Clinical Trial Manager

Senior Clinical Trial Manager

San Francisco, California, United States · QED Therapeutics

Description

The Senior Clinical Trial Manager (Sr. CTM) is responsible for managing operational activities of assigned clinical programs. This individual role provides a level of expertise, aligned with the principles and standard practices for operational activities of clinical trials QED Therapeutics. Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO oversight, training, vendor management and review of agreements related to CRO clinical activities. Partner with key stakeholders – internal and external – to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for functioning in a cross-functional environment. Global trial experience a plus.


Duties and Responsibilities:

  • Responsible for representing Clinical Operations (ClinOps) on cross-functional study teams and Vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
  • Provides leadership for ClinOps related issues and advise management team of potential issues and solutions
  • Responsible for the review and oversight of tasks in study monitoringplans for operations and all operational activities associated with clinical trials
  • Responsible for ensuring that all components of the trial master file (TMF/eTMF) are up to date and accurate for QED assigned investigational trials
  • Monitors global regulatory intelligence for global industry practices for operational efficiency and compliance
  • Responsible for operational guidance for investigators and provide CRO training related to the study conduct
  • Responsible for reviewing study budgets and master ICF templates for study start-up
  • Responsible for managing queries for clinical studies from CROs and address issues raised by CROs or other service providers
  • Participates in the conduct of audits and support regulatory inspections related to GCP
  • Addresses consistency in collection, processing and evaluation of clinical data
  • Contributes to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
  • Represents Clinical Operations on cross-functional teams
  • Supports QED sponsored clinical trials and development programs

Education:

Bachelor’s required in a scientific/medical field. Advanced degree preferred

Experience:

Minimum 8 years of experience in Clinical Operations, working with CROs and other vendors

At least 5 years of management experience in a clinical research environment
Previous experience working in cross-functional environment
History of successfully developing effective relationships with outside vendors and CROs
Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
Demonstrated skills in negotiation, multi-tasking, organization and decision making

Proficiency in databases, coding and data mining methodologies we well as Microsoft applications

Ability to travel to regional and global sites

Prior experience working in a start-up environment is a plus

If you are passionate about innovation and looking to join a thriving team, email your cover letter and resume to:careers@QEDTx.com

careers

Senior Clinical Trial Manager