Vita Global Sciences, a Kelly Company · 1 day ago
Sr. Study Manager
United States
Contract
Remote
Senior Level
$67/hr - $67/hr
7+ years expVita Global Sciences, a Kelly Company, is seeking a Sr. Study Manager for a long-term engagement with a Global Pharmaceutical client. The role involves leading and supporting clinical trials, managing operational activities, and ensuring compliance with trial deliverables.
AnalyticsData VisualizationInformation Technology
Responsibilities
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
Qualification
Required
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
Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required
Excellent oral (including presentation) and written communication, computer/database management, and project management skills required
BS/BA/MS/PhD
Preferred
MS Project experience preferred
OneNote experience preferred
TA-specific experience beneficial
Benefits
Medical
Dental
Vision
401K
Paid time off, including holiday, vacation, and sick/personal time
Company
Vita Global Sciences, a Kelly Company
From Research To Reality.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tim Southwick
President / Founder at Vita Global Sciences
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