US
0 suggestions are available, use up and down arrow to navigate them
What job do you want?

Study Director - Preclincal Surgical job in Minneapolis at NAMSA

Create Job Alert.

Get similar jobs sent to your email

List of Jobs

Apply to this job.
Think you're the perfect candidate?
Study Director - Preclincal Surgical at NAMSA

Study Director - Preclincal Surgical

NAMSA Minneapolis, MN (On Site) Full-Time
NAMSA pioneered the industry, NAMSA 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 whose:
• Mission is to make a scientific contribution to every medical device in the world.
• Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
• Values have stood the test of time.
• Above all else, conduct ourselves with integrity Job Description: NAMSA is a rapidly growing, global organization. We are always looking to connect with top talent in our industry. If you are experienced in managing preclinical studies, analyzing & interpreting study results, project management, have performed surgeries, and interested in learning more about being a study director at NAMSA, any of the below expert levels -- Apply today for IMMEDIATE consideration. Primary Duties and Responsibilities:
• - Associate Study Director (ASD)
• Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Understands the intended clinical use of the test article being evaluated.
• Handles challenging situations, and knows when to call-in help.
• Participates in study specific procedures as required.
• Performs project in compliance with regulations.
• Manages cross-functional projects effectively.
• Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable.
• Assist Study Director(s) with protocol and report development.
• Other duties as assigned.
• - Study Director In addition to the items listed above:
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Participates in client discussions regarding study design when needed.
• Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Establishes and ensures schedule, budget and quality commitments are met for the client.
• Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
• Assists with departmental training as needed.
• Other duties as assigned.
• - Senior Study Director In addition to the items listed above:
• Develops and leads moderately complex study design and protocols.
• Participates in client discussions regarding study design and product development goals including regulatory submission pathway.
• Prepares publications and/or presentations and participates in conferences, webinars, or other industry venues.
• Provides mentoring and training to other Study Directors.
• Other duties as assigned.
• - Principal Study Director In addition to the items listed above:
• Participates in client discussions regarding study design and product development goals including regulatory submission pathway.
• Develops and leads complex study design and protocols.
• Performs technical review and approval of specialized protocols and reports
• Identifies and develops ways to improve the technical/scientific skills and professional competency of SDs
• Speaks at conferences, webinars, or other marketing venues.
• Other duties as assigned. Role-Specific Duties and Responsibilities
• Serves as the Study Director for GLP and non-GLP preclinical studies and is the single point of control for multidisciplinary preclinical projects (In Vivo and In Vitro Biocompatibility, Chemistry, Microbiology, Surgical).
• Develops study design and protocol as well as specific data collection forms.
• Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary.
• Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report.
• Coordinates and manages client expectations.
• Interacts with regulatory bodies, including but not limited to FDA.
• Travels as needed to manage client expectations. Sales/Marketing Duties and Responsibilities
• Assist in study design and provides scope of project and relevant information to support the creation of proposals
• Participates in meetings with prospective and current clients.
• Identifies opportunities to bring in new projects/clients.
• Offers opportunities to clients for expansion of MRO services to be provided by NAMSA. Qualifications and Skills:
• - Associate Study Director
• Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with 1-3 years of related laboratory experience or 5 years relevant experience without the degree.
• Scientific certification a plus (ie. ALAAS or ALAT)
• Fluency in English and local language, if different, required.
• Advanced degree may be required for EMEA and APAC locations.
• - Study Director
• Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with 2- 4 years related laboratory experience or 8 years relevant laboratory experience without a degree.
• Master's degree/PhD with a minimum of 1 year of relevant laboratory experience.
• Advanced degree required for EMEA and APAC locations.
• Previous study director experience preferred
• Project management experience and regulatory interface preferred
• Scientific certification a plus (ie. ALAAS or ALAT)
• Fluency in English and local language, if different, required.
• -Senior Study Director
• Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with 4 - 6 years related GLP laboratory experience or 10 years relevant experience without a degree. Three years previous study directing experience preferred.
• Master's degree/PhD with a minimum of 3 year of related GLP laboratory experience. Three years previous study directing experience preferred.
• Advanced degree required for EMEA and APAC locations.
• Project management experience and regulatory interface preferred
• AALAS certification recommended.
• Fluency in English and local language, if different, required.
• -Principal Study Director
• Bachelor's degree in a scientific discipline with a minimum of 8 years of related GLP laboratory experience. Minimum of 6 years previous study directing experience.
• Master's degree with a minimum of 6 years of related GLP laboratory experience. Must include at least 4 years of previous study director experience and/or
• PhD with a minimum of 5 years of related GLP laboratory experience. Must include at least 3 years of previous study director experience.
• Advanced degree required for EMEA and APAC locations.
• Project management experience and regulatory interface required.
• DABT recommended.
• Fluency in English and local language, if different, required. Technical Competencies:
• Knowledge of Good Laboratory Practices for Nonclinical Laboratory Studies (21 CFR Part 58), highly desirable
• Knowledge and experience with quality systems
• - Laboratory and Surgical experience required in some roles
• Familiarity with medical device development process from pre-clinical to commercialization
• Awareness of applicable guidelines and regulations including, but not limited to USDA, USP, FDA, ISO, MHLW
• Demonstrated knowledge of a laboratory, analysis of scientific data, technical writing, organizational and communication skills. Working Conditions
• 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kgs). Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard. Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job. NAMSA reserves the right to revise duties as needed.

Recommended Skills

  • Manufacturing Operations
  • Iso 9000
  • Kanban Principles
  • Total Quality Management
  • Value Stream Mapping
  • Just In Time
Apply to this job.
Think you're the perfect candidate?

Help us improve CareerBuilder by providing feedback about this job:

Job ID: da45lnp

CareerBuilder TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.