Senior Clinical Study Manager - Medical Devices (Hybrid)

Actalent; Minneapolis (MN); Hybrid; USD 140,000 - 180,000; Full time

Benefits offered by this job

401k matching

ESPP

Flexible time off

Tuition reimbursement

Job summary

Actalent in Minneapolis, MN is seeking a Clinical Study Manager to oversee clinical activities across multiple studies and ensure compliance with GCP/21 CFR 812. The role involves coordinating with internal teams and CROs, managing safety reporting, site activation, monitoring, and data management to support study success.

The ideal candidate has at least 5 years of medical device study management experience, a Bachelor’s degree, and strong technical writing skills.

Qualifications

• Minimum 5 years of medical device experience as a study manager.
• Bachelor's degree required.
• Understanding of GCP and 21 CFR 812.
• Strong knowledge of clinical research study design and study monitoring functions.
• Experience working with Institutional Review Boards and/or Ethics Committees.
• Strong technical writing skills.

Responsibilities

• Manage clinical studies in accordance with SOPs and applicable regulations.
• Collaborate with internal/external teams and CROs to draft study protocols and documents.
• Oversee site selection and activation.
• Manage safety by tracking adverse events and DSMBs/independent committees.

Skills

Medical device experience

Study management

GCP compliance

Technical writing

IRB experience

Education

Bachelor's degree

Job description

Actalent in Minneapolis, MN is seeking a Clinical Study Manager to oversee clinical activities across multiple studies and ensure compliance with GCP/21 CFR 812. The role involves coordinating with internal teams and CROs, managing safety reporting, site activation, monitoring, and data management to support study success.

The ideal candidate has at least 5 years of medical device study management experience, a Bachelor’s degree, and strong technical writing skills.