Careers

Clinical Study Manager

Oversee and manage clinical trials for all phases in partnership with other functions

Position -

Oversee and manage clinical trials for all phases in partnership with other functions

Reports To -

Clinical Operations Director

Responsibilities

  • Participate in the review of the protocol, collects and communicates suggestions for protocol changes to responsible author
  • Review and approve protocol related documents; ICF, Study plans, eCRF. Ensure all study related plans and manuals are complete and revised as needed
  • Collaborate and work closely with the Clinical operations department to identify vendors; CRO, central lab, consultants etc.
  • Establish the study budget with the assistance of the study team. Manage the study budget to ensure accurate and timely payments to vendors
  • Prepare recruitment projection and select countries and sites in collaboration with the study team
  • Facilitate all start up activities including setup of study supporting systems and platforms
  • Review final proposals and approves vendor contracts.
  • Manage the study team meetings and actively interact with key functions such as CRO/external vendors, Medical Monitor, Quality Assurance, Regulatory, Clinical Supply etc.
  • Provide logistic support of DSMB meetings, coordinate and distribute agreed DSMB deliverables
  • Address and follow issues identified by the DSMB
  • Develop Key Performance Indicators (KPI) to track vendor performance
  • Proactively monitors trial progress, timelines and financial metrics on an ongoing basis, identify study related issues and manage them to resolution
  • Provides the Clinical Operations Director with regular updates that include progress on recruitment, data collection, quality and budget information
  • Plan and manage Investigators Meeting in close collaboration with study clinical team and vendors
  • Ensure that training and study information and materials are provided to all CRO/vendor personnel participating in the conduct of the study
  • Clinical Study manager may lead or participate in such trainings
  • Ensure compliance with quality standards (SOPs, GCP, etc.)
  • Participate in the review, development and revision of departmental SOPs
  • In case of premature study termination or temporary suspension, leads the appropriate follow up, establish trial termination plan and distribution to the vendors and ensure accomplishment with SOPs and regulatory requirements
  • Ensure ongoing presence of all essential documents and that TMF is complete and up to date at the study end
  • Participate in the review of CSR and provide operational input and support. Distribute summary of the CSR to the relevant parties

Qualifications

  • BS/BA degree required in science/health related field
  • Minimum 5 years of experience in Bio-pharmaceutical Research and Development
  • Previous experience in management of domestic and international clinical trials
  • Excellent working knowledge of ICH GCP guidelines
  • Team player who can also work independently
  • Excellent written and oral communication in English
  • Strong leadership skills; manage study team and vendors
  • Ability to prioritize tasks, flexible to changing priorities and able to meet deadlines
  • Good presentation skills
  • Good computer skills
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