Clinical Research Manager
TEI Biosciences Inc - Waltham, MA

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Company Overview

TEI Biosciences is a fast-growing biomedical company developing, manufacturing, and marketing collagen-based biologic devices for the repair and reinforcement of soft tissues and for the management of wounds. In addition to product lines with major market partners, TEI currently markets and directly sells SurgiMend®, indicated for hernia repair and breast reconstruction and PriMatrix™, indicated for wound healing

Position Description

The Clinical Research Manager will work with a small, in-house and contract team of clinical studies experts to manage prospective and retrospective post-market clinical studies and FDA-regulated IDE clinical trials of the Company’s acellular dermal matrix product for plastic and reconstructive surgery.

Accountabilities

The following represents a list of essential goals and responsibilities. Other duties may be assigned as required.

  • Manage in-house and contract Research Associates and contract Statisticians
  • Study documentation preparation and submission, including IRB/IDE protocols, Informed Consent Forms, and CRFs and brochures
  • Perform data collection, analysis, and reporting from paper and electronic sources
  • Prepare and edit manuscripts for peer-review and publication
  • Ensure cGCP quality systems compliance and documents management
  • Perform clinical site visits and attend medical meetings as needed
  • Organize and prioritize CRA and department activities to effectively and efficiently meet Company and study goals

Qualifications and Requirements

  • 5 - 7 years industrial experience in clinical trials, including IDE Medical Device experience
  • Minimum BS/BA in a Biological or Clinical science; advanced degree preferred
  • Prior experience with IDE, 510(k), PMA preparation and cGCP quality systems
  • Prior OR observation experience strongly preferred
  • Willing to travel domestically up to 50% of the time
  • Strong verbal and written English skills
  • Proficient in Microsoft Office, other pertinent software and systems

Please visit us at http://www.teibio.com/

TEI Biosciences Inc. is an Equal Opportunity/Affirmative Action Employer