Core Lab Project Lead

North American Science Associates, Inc.; España; Remote; EUR 61,000 - 119,000; Full time

Job summary

NAMSA, a leading MedTech testing and regulatory support company, is seeking an Imaging MOP Specialist to assist with document development, data transfer specs, and training materials for multi-centered clinical trials. You will coordinate with NAMSA teams, project/site managers, Sponsors, vendors, and regulatory agencies to ensure timely delivery.

The role requires a Life Sciences degree and at least two years in clinical research, with strong organization, MS Office proficiency, and EDC systems

Qualifications

• Bachelor's degree in Life Sciences or related field.
• At least 2 years' experience in clinical research or related field.
• Experience with project coordination/management preferred.
• Strong knowledge of industry acronyms and medical terminology.
• Excellent verbal and written communication skills.

Responsibilities

• Assist with the development and execution of Imaging MOPs and related regulatory documents for multi-centered clinical trials.
• Liaise between NAMSA teams, project/site managers, study sites, Sponsors, vendors/subcontractors, consultants, and regulatory agencies.
• Assist with training assignments for Core Lab staff, vendors, and consultants.
• Attend study team and internal meetings, provide status updates and action items.
• Assist with core lab image processing and data entry as needed.

Skills

Verbal communication

Written communication

Team collaboration

Attention to detail

Time management

Education

Bachelor's degree in Life Sciences or related field

Tools

Microsoft Office

EDC systems

Project management tools

Job description

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas.

Compensation Target: $0.00

Job Description:

• 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.

Qualifications & Technical Competencies:

• Bachelor's degree from a four-year college or university (in Life Sciences or related field preferred).
• At least 2 years' experience in clinical research or related field required.
• Experience with project coordination/management preferred.
• 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.
• Experience in acquisition or review of medical imaging is desirable.

Working Conditions:

• Travel may be required depending on the client's or business needs.
• The duties of this job can be performed onsite or remotely.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to sit and talk or hear.
• The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms.
• Physical activities include sitting for periods of time and occasionally standing and walking.
• Extensive use of computer keyboard.

The compensation grade range for this position is: $68,800.00 - $133,700.00 - Annual

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

NAMSA was founded on the principals of delivering quality customer service, conducting ourselves with integrity, respect for one another, open communication and collaboration.

Whether you have a background in Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering, or Sales & Business, NAMSA offers exciting opportunities to align with your expertise.