Sr. Clinical Study Manager

Actalent; United States; Hybrid; USD 140,000 - 180,000; Full time

Benefits offered by this job

Excellent benefits

401k matching

ESPP

Flexible time off

Tuition reimbursement

Job summary

Actalent is seeking a Clinical Study Manager to oversee multiple medical device studies, ensuring regulatory compliance and efficient in-house operations. The role involves collaboration with CROs, safety oversight, and data management coordination in a hybrid Minneapolis setting.

Requires 5+ years of medical device study management, a Bachelor’s degree, and strong writing skills. Expect cross-functional teamwork, protocol drafting support, and contribution to publications as needed.

Qualifications

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

Responsibilities

• Oversee multiple clinical studies in compliance with SOPs and regulations.
• Collaborate with internal/external teams and CROs to draft study protocols and docs.
• Oversee site selection and activation for studies.
• Monitor safety by tracking adverse events and reporting trends.
• Lead monitoring activities, plan reviews, and action on findings.
• Coordinate study-related calls and Investigator meetings.
• Manage investigational device allocation, distribution, and reconciliation.
• Collaborate with data management/CRO for data capture and queries.
• Assist with abstracts, posters, manuscripts as needed.
• Ensure timely documentation and training competency.

Skills

GCP knowledge

Technical writing

Study design

Cross-functional teamwork

IRB/EC experience

Education

Bachelor's degree

Job description

Job Title: Clinical Study Manager

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.

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 TEAMAt 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!

Job Type & Location

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

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.