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Clinical Research Manager

Company: BISCO
Location: Schaumburg
Posted on: January 5, 2022

Job Description:

BISCO is seeking an ambitious Clinical Research Manager to join our thriving organization. We are an internationally recognized manufacturer of medical devices for the dental industry, specializing in the advancement and research of adhesive and composite technology. Our Clinical Research Manager will play an important part in helping us grow.

This position will plan and oversee primary user/product research and clinical research documentation process throughout the complete product life cycle.

To the right Clinical Research Manager, we offer:
Competitive annual base starting from $83K to $104K, commensurate with experience
Medical, dental, life, vision, and short-term and long-term disability insurance, and FSA/DCA
401(k) with company match and potential profit sharing
Generous Paid Time Off (PTO) and paid holidays
Opportunity for career growth

Duties and Responsibilities:
Leadership - Provide direction and oversight to direct reports, conduct performance management activities, and maintain a positive working environment.
Principal Technical Writing / Research - Manage and provide writing of technical documentation including clinical evaluation reports, post-market surveillance reports, post-market clinical follow-up reports, periodic safety update reports, and summaries of safety and clinical performance.
Primary User / Product Research - Oversee primary user / product research including clinical research (verification, validation, usability, and PMCF) and non-clinical research for product planning and strategy.
Risk Management - Manage the risk management process, including contributions to PDs in design control, lead risk management task force.
Biocompatibility - Oversee the update and maintenance of biocompatibility evaluations for existing products and ensure they comply with current standards and regulations.
General - Support design control, work with Clinical Affairs and Regulatory Affairs, provide writing, editorial, and regulatory support to Marketing.

Requirements:
Bachelor's degree required. Advanced degree preferred. Degree in science, medicine, dentistry, or similar discipline highly preferred.
Technical writing: 8+ years with bachelor's degree, 5+ years with master's degree, 2+ years with doctoral degree.
EU regulatory document writings.
Project coordination experience.
Proficient in MS Office and general computer skills.
Strong organizational skills, multi-tasking, and self-motivation.
Strong verbal and written English communication skills.
Exceptional level of attention to detail.

This position will be required to work out of the Schaumburg, IL office.

Why BISCO, INC.?

Bisco, Inc. stands out because of our culture and core values:
Respectful - Professional. Humble. Considerate.
Positive - Friendly. Inclusive. Curious.
Team Player - Helpful. Cooperative. Flexible.
Agility of a small company but the stability of a big company
Industry-leading dental restorative products
Broad exposure to activities across the company
Family-oriented environment with positive team players
Approachable, respectful, and down-to-earth people
Long-tenured employees to whom the leadership is committed
Employees feel valued and are proud to be a part of the company
Monthly whole-company fun events!

Since 1981, BISCO has provided innovative medical and dental products to dental customers around the world. Our primary focus is adhesive and composite technology. Located northwest of Chicago in Schaumburg, our advanced research facility includes on-site ISO 13485 certified manufacturing. Our privately-owned organization provides the opportunity for a close-knit environment that encourages inter-departmental collaboration. For more about us, please visit our website at www.bisco.com.

Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday

EOE

No agencies, please.

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Keywords: BISCO, Schaumburg , Clinical Research Manager, Executive , Schaumburg, Illinois

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