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Kelly Science, Engineering, Technology & Telecom · 16 hours ago

Clinical Trial Manager

United States

Full-time

Remote

Senior Level

7+ years exp

Kelly Science, Engineering, Technology & Telecom is seeking a Senior Study Manager to support their global pharmaceutical partner. The role involves leading clinical trial activities, managing operational deliverables, and ensuring compliance with protocol requirements while overseeing the Clinical Trial Team.

Staffing & Recruiting

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

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

Qualification

Clinical Trial ManagementPharmaceutical ExperienceProject ManagementMS ProjectExcelPresentation SkillsDatabase ManagementRisk AssessmentCommunication SkillsTeam Leadership