Manager, Clinical Study Start-Up

Your Remote US Home Officefull timeRemote

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senior

$135k–$187k

H1B: no

Penumbrainc Manager of Clinical Study Start-Up leading Clinical Research Associate and Clinical Budget Analyst teams. Oversees study start-up activities including regulatory documentation, budgets, vendor management, and site activation.

Responsibilities

Lead study and site start-up execution and activation
Develop study start-up materials and documents
Prepare and negotiate clinical trial budgets
Manage clinical study registrations and reporting
Provide updates on site start-up progress and delays
Monitor and report study start-up performance metrics
Oversee IRB and EC submissions and responses
Drive continuous improvement and SOP implementation
Recruit, hire, and supervise ICRA and CBA team members
Allocate resources and manage project timelines
Identify and escalate site and study issues
Serve as liaison between cross-functional teams

Qualification

Minimum education and experienceBachelor's degree in BiologyKnowledge of ICH-GCPs and 21 CFRMedical device experience desirableStrong oralExcellent organizational skillsStrong computational skillsAbility to apply strong analyticalWorking ConditionsGeneral office environmentWillingness and ability to work on site

Required

Minimum education and experience:
Bachelor's degree in Biology, Nursing, Biomedical or Physical Sciences or related field with 7+ years of experience in preclinical research, or medical devices/pharmaceutical industry, or an equivalent combination of education and experience.
3+ years’ experience in the operational aspects of managing clinical studies from start-up to close-out, vendor management, and planning cross-functional operational activities required.
Knowledge of ICH-GCPs and 21 CFR, and other relevant regulations and standards.
Experience creating and negotiating clinical budgets and contracts.
Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.

Preferred

Medical device experience desirable
Strong oral, written, and interpersonal communication skills
Excellent organizational skills, with ability to prioritize assignments while handling various projects simultaneously
Strong computational skills; proficiency with Microsoft Office (Word, Excel, OneNote, and PowerPoint)
Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts, and techniques.
Working Conditions
General office environment
Willingness and ability to work on site.

Benefits

Equity/RSU

Company

Penumbrainc

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Source: lever

Active within the past hour

Remote-friendly

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