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Senior Study Manager

Parexel International Corporation

Remote, Quebec, Canada

Senior Study Manager (SSM)

Primary Duties:

  • Operational point of contact for trial execution and all trial deliverables
  • Manages all Headquarters (HQ) Operational Activities, including: establishes, leads and manages Clinical Trial Team (CTT), supports clinical (drug/vaccine) supplies planning
  • Manages deployment and interactions with external vendors [e.g. Interactive Voice Response System (IVRS), Patient Reported Outcomes (PRO)]
  • Initiates planning for Investigator meetings and protocol training
  • Plans and assesses protocol ancillary supplies
  • Completes trial set-up and maintains SPECTRUM
  • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
  • Initiates recruitment/retention planning & enrollment tracking
  • Responsible for tracking study related details (e.g., specimens, queries)
  • Oversees protocol training activities including Investigator Meetings (IM) and Clinical Research Associate (CRA) training meetings
  • Ensures appropriate postings to investigative site portals
  • Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets (with input from others)
  • Point of escalation for study related operational issues
  • Responsible for operational details at Operational Reviews
  • Responsible for creating and maintaining project schedule and collaborating with Program Lead
  • Sets up and maintains Trial Master File (eTMF)
  • Ensures alignment of budget with protocol needs
  • Responsible for executing protocol within the budget
  • Responsible for risk assessment, mitigation planning and execution
  • Responsible for creating and maintaining Actions, Decisions, Issues (ADI) Logs
  • Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group
  • Develops study related manuals (e.g., administrative binder, lab manuals)
  • Manages Emergency Unblinding (EUB) Call Center activities
  • Co-authors newsletters with Clinical Scientist (CS)
  • Approves contracts, invoice payments and change orders for vendors, as necessary
  • Responsible for end of study reconciliation (clinical and ancillary supplies)
  • Oversees all HQ close-out tasks
  • Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking
  • Supports CS activities as needed to achieve CTT deliverables
  • Interface with External Data Coordination and Data Management
  • Responsible for quality control and inspection readiness at all times
  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
  • Adhere to EP and Client SOPs and processes

Skills and Education:

  • BS/BA/MS/PhD with 7+ years clinical research experience
  • Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required
  • Proven ability to meet aggressive timelines
  • Excellent Excel and PowerPoint skills required
  • Excellent oral (including presentation) and written communication, computer/database management, and project management skills required
  • MS Project experience preferred
  • Therapeutic Area (TA) specific experience beneficial

Job posted: 2023-02-24

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