Clinical Study Manager

Benefits

Parental leave

Not verified

Non-birth-parent leave

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Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

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Learning budget

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Verification

Not verified

Salary

$123K-$170K not verified - source not recorded; timestamp not recorded

401(k) match

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Market context

U.S. role benchmark (BLS OEWS)

$81,444 U.S. median for this role

Projected growth (BLS Employment Projections)

+6.9% - Faster than average

80% above the BLS role benchmark for healthcare aggregate.

Matched to SOC 29-1141 - Healthcare aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Schedule

Shift type

Not verified

Weekend work

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Application

Cover letter

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Assessment

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Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Clinical Study Manager Your Remote US Home Office General Summary The Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This position works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders. Understands business environment and relates extensive knowledge of internal and external activities to trends. Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. Specific Duties and Responsibilities •Develops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions) * •Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees as directed by management. * •Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquarters. * •Negotiates study budgets with sites, Core Labs, and other vendors. * •Attends site visits as necessary (e.g., site initiation, monitoring, and close out visits). * •Contributes to process improvements that help foster continuous improvement. •Helps update and maintain study trackers and dashboards. •Participates in system user acceptance testing. •Manages vendors such as Core Lab.* •Organizes and manages Investigator Meetings. •Works with data management to develop systems for and track project metrics. •Drives development, approval, and distribution of study-related documents including Case Report Forms, study manuals* •Leads activities for internal and regulatory

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