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Role Description

Senior Study Manager may lead or support a study or studies, depending on size/complexity. As lead, will be responsible for the following:

• Operational point of contact for trial execution and all trial deliverables
• Manages all 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., IVRS, PRO)
• Initiates planning for Investigator meeting and protocol training
• Plans and assesses protocol ancillary supplies
• Completes trial set-up and maintains CTMS
• 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 IMs and CRAs 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 creating and maintaining 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 CS
• Approves contracts, invoice payments and change orders for vendors, as necessary
• Responsible for end of study reconciliation (clinical & 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
• Responsible for risk assessment, mitigation planning and execution

Qualifications

• BS/BA/MS/PhD with 7+ yrs clinical research experience
• Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required
• Proven ability to meet aggressive timelines
• MS Project experience preferred
• Excellent Excel and PP skills required
• TA - ID/Vaccines experience required
• Global experience required
• Excellent oral (including presentation) and written communication, computer/database management, and project management skills required
• Home Based position in US or Canada

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others