Clinical Research Manager

2 months ago

Conshohocken, Pennsylvania, United States Extremity Care Full time
Job Description

Job Summary:

The Clinical Research Manager will play a crucial role in the planning, development, execution, and maintenance of clinical trials to evaluate the safety, effectiveness, and performance of medical devices and tissue products at Extremity Care. This position requires a strong understanding of clinical research principles, regulatory requirements, and project management skills to ensure compliance with FDA regulations, state requirements, ISO standards, AATB standards, and company Standard Operating Procedures (SOPs).

Key Responsibilities:

  • Study Planning and Management: Establishes, implements, and manages clinical study projects, including project planning, clinical study design development, and collaboration with Contract Research Organizations (CROs) and other functional groups.
  • Regulatory Compliance: Ensures clinical studies are conducted in compliance with applicable regulations, Institutional Review Board (IRB) requirements, and company policies and procedures.
  • Document Control: Prepares and submits required documentation to IRBs for approval, maintains approval throughout the study duration, and ensures compliance with IRB reporting requirements.
  • Training and Education: Provides training to clinical investigators and staff on data collection and reporting requirements, as necessary.
  • Data Management: Supports data management activities, including the development and implementation of electronic data capture (EDC) systems to ensure proper recording, collection, verification, validation, processing, analysis, and storage of information collected in a clinical study.
  • Reporting and Communication: Provides status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, investigators, and senior management.
  • Procedure Development: Develops and/or updates clinical-specific procedures to ensure continued compliance with changing domestic and international regulatory requirements and to align with corporate policies and procedures.
  • Regulatory Support: Supports Regulatory Affairs with regulatory filings and registrations, including the development of annual progress reports (APRs), clinical study reports (CSRs), and clinical expertise related to FDA submission questions.

Requirements:

  • Education: Bachelor's degree in biological science or related field required; advanced degree preferred.
  • Experience: A minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials.
  • Skills and Abilities: Strong project management competencies, ability to work with high quality, reliability, and attention to detail; strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with partners.

Working Conditions:

This position requires the ability to work independently and as a member of a cross-functional team, with a strong sense of urgency and commitment to meet highly aggressive timelines. The Clinical Research Manager will work closely with cross-functional team members to manage clinical projects through operational planning and logistical management to meet departmental and company objectives.

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