Kelly Science and Clinical FSP is currently seeking a Sr. Study Manager for a long-term engagement with one of our Global Pharmaceutical clients. This position is remote working EST hours. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Sr. Study Manager
Description of Services

• 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 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 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
• Coauthors 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 closeout 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 Years of Experience

• At least 7 year Pharmaceutical and/or clinical drug development experience (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required
• Minimum 2 years as a lead SM (phase I-IV clinical trials) with pharmaceutical/bio-tech/CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years.
• Demonstrated experience in leading cross-functional teams including vendor management, eTMF, budget management and timeline management
• Demonstrated experience to meet aggressive timelines in a matrix organization,
• MS Project experience preferred
•  Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required; OneNote experience preferred
• TA-specific experience beneficial
• Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

Educational Requirements

• BS/BA/MS/PhD