Careers

Clinical Study Manager

The clinical study manager is responsible for the implementation and management of global clinical trials for all clinical phases in partnership with other functions.

Position -

full time

Reports To -

Clinical Operations Director

Responsibilities

Start time: immediate

The clinical study manager is responsible for the oversight and execution of the below study-related activities, managing the collaboration with the study team, including clinical operations and other crossfunctional functions, and the CRO and other external vendors.

  • Oversee the authoring and review of the protocol, collects and communicates
    suggestions for a protocol change to responsible author.
  • Manage the identification of vendors; CRO, Central lab, consultants etc.
  • Establish the study budget. Manage the study budget to ensure accurate and timely
    payments to vendors.
  • Prepare recruitment projection and select countries and sites.
  • Responsible for the execution of protocol related documents; ICF, Study plans, eCRF.
  • Ensure all study related plans and manuals are complete and revised as needed.
  • Facilitate all start up activities including setup of study supporting systems and
  • platforms, including 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.
  • Oversee ongoing study conduct including patient recruitment and follow-up, data
    entry and monitoring, site and vendor performance, safety assessments.
  • Oversee the execution 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.
  • 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 maintenance 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

  • Previous experience in management of international clinical trials is mandatory.
  • BS/BA degree required in science/health related field.
  • Minimum 5 years of experience in Bio-pharmaceutical Research and Development
  • 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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