Sr. Study Manager

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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.