Senior Clinical Study Manager

Kelly Science, Engineering, Technology & Telecom

United States

On-site

USD 135,000 - 145,000

Full time

14 days+

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Benefits offered by this job

401(k)

Vision insurance

Medical insurance

Job summary

A healthcare staffing agency is seeking a Senior Clinical Recruiter to lead clinical trials and manage operational activities. The ideal candidate has over 7 years of experience in pharmaceutical and clinical drug development, showcasing strong project management skills. This role offers a competitive salary and comprehensive benefits including medical and vision insurance.

Qualifications

At least 7 years of Pharmaceutical and/or clinical drug development experience (Pharma/CRO) in the last 10 years required.

Responsibilities

Lead or support a study or studies based on size/complexity.
Operational point of contact for trial execution.
Manage all HQ Operational Activities and Clinical Trial Team.

Skills

Drug development knowledge

Project management

Vendor management

Job description

Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$135,000.00/yr - $145,000.00/yr

Direct message the job poster from Kelly Science, Engineering, Technology & Telecom

Senior Clinical Recruiter at Kelly Services

Description of Services:

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 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