Clinical Study Manager

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.