Sr. Clinical Study Manager

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

Job Description

This position involves overseeing clinical activities related to one or more clinical studies, managing daily in-house operations associated with the studies, and ensuring compliance with applicable regulations and guidelines. The Clinical Study Manager must work independently on multiple complex clinical studies using critical thinking skills, and may be part of a small, cross-functional team or have direct reports.

Job Title: Clinical Study Manager

Responsibilities

• Manage clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines.
• Collaborate with internal and external clinical team members, consultants, and/or CROs to draft clinical study protocols and other clinical study documentation.
• Oversee clinical site selection and activation.
• Manage study safety by tracking and reporting adverse events, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards.
• Oversee monitoring activities related to assigned clinical studies, including review and approval of monitoring plan and monitoring reports, managing monitoring schedule, and ensuring corrective action related to monitoring findings.
• Organize and lead study-related conference calls and Investigator meetings as needed through the study.
• Oversee investigational device allocation, distribution, and reconciliation.
• Collaborate with data management team and/or CRO to ensure appropriate data capture, query management, and identify data analysis needs.
• Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed.
• Document product and therapy-related field reports within prescribed timelines and provide necessary documents for investigation.
• Complete training requirements and competency confirmations within the required timeline.
• Comply with applicable quality system procedures/policies and suggest continuous process improvements.

Essential Skills

• Minimum 5 years of medical device experience as a study manager.
• Bachelors 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.

Job Type & Location

This is a Permanent position based out of Minneapolis, MN.

Pay And Benefits

The pay range for this position is $140000.00 - $180000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If youre passionate about making a difference in peoples lives and want to work with innovative technology, come be a part of our great team!

Application Deadline

This position is anticipated to close on Nov 11, 2026.

Workplace Type

This is a hybrid position in Minneapolis,MN.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.