Sr. Scientist

We have an urgent job opening with our Direct client. Please go through the job description and let me know the following information: 

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Client                    : Direct

Title                       : Sr Scientist

Job ID                    : MEDTJP00036170

Location               : Minneapolis MN 55448

Duration              : 24 Months

Pay Rate              : Negotiable

Description:

Top 3 skills or experience needed:

1. Study Director or Study Coordinator for Preclinical research

2. GLP (Good Laboratory Practice) experience.

3. Program Management

4 year degree + 4 yrs relevant experience (or advanced degree with a minimum of 2 years relevant experience) is needed.

MAIN PURPOSE OF JOB (BRIEF SUMMARY)

The senior scientist contractor acts as a Preclinical study director. The responsibilities of the study director include: managing preclinical animal research studies that evaluate the safety and efficacy of medical products from Medtronic businesses; ensuring compliance to all applicable regulations in the execution of these studies; applying scientific, clinical, and/or engineering expertise to facilitate success of these projects; and contributing to evolving business systems and practices.

MAIN JOB DUTIES/RESPONSIBILITIES (Please list most important duties first)

Preclinical Study/Project Management

• Manages all preclinical study activities within and outside of PRL; ensures the availability of the proper devices and equipment to successfully conduct the study, to control test devices to insure integrity; determines study schedules; and determines study objectives; ensures all aspect of the data package meet protocol requirements and expected scientific practices; all with input from the project team. Routinely oversee study activities in the surgical operating room, vivarium, necropsy, and other lab areas, including (but not limited to) exposure to surgical and pathology animal and human tissue research.

• Leads a multidisciplinary team in the development, conduct and completion of Preclinical studies. This team is made up of numerous functions, including: quality assurance, surgical and veterinary support, animal care, clinical chemistry, pathology, project managers, engineers, and researchers.

• Partners with other scientists, researchers and engineers in the development of study designs, protocols, and final reports; independently manages studies of significant complexity (e.g. disease states, extensive data collection); contributes to overall preclinical strategy for collaborative sponsor groups

Regulations

• The study director serves as the single point of study control and is ultimately responsible for the compliance of the study to Good Laboratory Practices, the Animal Welfare Act, and all other applicable regulations.

• Interfaces with quality assurance, regulatory committees (e.g. IACUC), and Regulatory Affairs regarding requirements and results of the study.

• Reviews Preclinical study data intended for regulatory submissions for compliance to Good Laboratories Practices.

• Establishes department and facility standards for regulatory compliance.

Core Expertise

• Applies core scientific and/or clinical expertise that supports the product plans and research objectives of the businesses he or she supports.

• Researches and develops appropriate animal models that will meet the needs of the studies and research goals. Develops surgical and disease state animal models. Applies scientific and/or clinical expertise to act as a primary expert on therapies and/or disease states within and/or outside PRL.

• Contributes to Medtronic’s body of scientific knowledge by authoring/coauthoring and/or presenting scientifically unique findings to either a Medtronic audience or the medical and scientific community at-large.

Good Laboratory Practice

Employees must conform to the SOP’s and documentation that applies to their work areas. This includes proper documentation techniques, updating the SOP’s, training on the SOP’s and knowledge of the GLP regulations that apply to their area.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

May have practical knowledge of project management.

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Kathy Jose
Sr Recruiter,
Tel: 408-913-1479,
Email: Keerthana@infobahnsw.com,
Infobahn SoftWorld Inc., San Jose, CA 95131.