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NAMSA · 2 days ago

Core Lab Project Lead

Minneapolis, MN

Full-time

Hybrid

Entry, Mid Level

$67K/yr - $80K/yr

2+ years exp

NAMSA is a pioneering company in the medical device materials industry, focusing on safety and regulatory compliance since 1976. The Core Lab Project Lead will assist in the development and execution of regulatory documents for clinical trials, liaise with various stakeholders, and support core lab operations and data management.

Medical Device

H1B Sponsor Likely

Responsibilities

Assist with the development and execution of Imaging Manual of Operations and Procedures (MOP), Core Lab Data Transfer Specifications, Image Transfer Training presentations, and other study-specific regulatory documents for multi-centered clinical trials as needed

Liaise between NAMSA, project/site managers, study site coordinators, CRAs, Sponsors, vendors/subcontractors, consultants, and/or regulatory agencies to assist with document development, trainings, image review tracking, and meeting organization

Assist with ensuring that proper trainings are assigned to Core Lab staff members, vendors/subcontractors, and consultants

Attend and actively participate in study team meetings and internal staff meetings, providing status updates, path forward recommendations/solutions and tracking action items as needed

Assist with core lab image processing and image tracking as needed

Assist in proper billing/invoicing and resolving any billing issues with Finance for assigned projects as appropriate

Assist with core lab data entry as needed

Complete any additional work as required and assigned by Management

Qualification

Clinical research experienceMedical terminology knowledgeProject coordination/managementMicrosoft Office proficiencyElectronic Data Capture systemsCommunication skillsInterpersonal skillsTeam collaborationAttention to detailTime management skills

Required

At least 2 years' experience in clinical research or related field required

Strong knowledge of industry acronyms and medical terminology

Demonstrated organizational skills, time management skills, proactive, and displays a professional demeanor with focus on compliance and responsibilities

Excellent verbal and written communication skills

Excellent interpersonal skills

Ability to work collaboratively and effectively in a team environment

High attention to detail and level of accuracy, tact, judgement, and discretion

Proficient with Microsoft Office including Outlook, Word, and Excel

Proficient in learning/utilizing various software applications and computerized systems including but not limited to Electronic Data Capture systems and project management tools

Ability to perform basic searches via the internet or other comparable data repositories

Preferred

Bachelor's degree from a four-year college or university (in Life Sciences or related field preferred)

Experience with project coordination/management preferred

Experience in acquisition or review of medical imaging is desirable

Company

NAMSA

NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.

Founded in 1967

Northwood, Ohio, USA

1001-5000 employees

http://www.namsa.com/

H1B Sponsorship

NAMSA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)