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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