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 risk assessment, mitigation planning and execution
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
Minimum FTE Years of Experience
Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead SM required
Proven ability to meet aggressive timelines
MS Project experience preferred
Excellent Excel and PP skills required
Oncology Therapeutic Experience
Excellent oral (including presentation) and written communication, computer/database management, and project management skills required
Educational Requirements
BS/BA/MS/PhD with 7+ yrs clinical research experience
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Kelly Science, Engineering, Technology & Telecom by 2x