This position will manage the activities required to assure compliance with applicable regulations and industry accepted standards that govern clinical studies. This position will provide oversight in all activities leading to or potentially leading to a regulatory filing (i.e., pre-market approval (PMA), investigational device exemption (IDE), investigational new drug application (IND), biologic license application (BLA), new drug application (NDA), FDA-mandated post-market studies (PMS) and market-driven PMS). This function is responsible throughout the clinical development process and post-launch clinical studies, from design of the protocol to the final clinical study report to insure compliance with applicable governmental regulations as well as company policies and procedures.
- Ensures clinical compliance with respect to the development of all trial related documentation, such as clinical protocols, Informed Consent Forms, and risk assessments related to clinical trial execution.
- Oversees Class III medical device and Phase 1-3 clinical studies in regards to assuring compliance against relevant internal SOPs, the study’s protocols, Good Clinical Practice guidelines, and regulations including the CFR and ISO 14155 requirements.
- Organizes, leads, and conducts QA inspections/audits/reviews of clinical trials to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements.
- Plans and implements specifics projects related to the development and improvement of the quality assurance clinical auditing program.
- Assists in the preparation of clinical sites for audit by Regulatory Authorities.
- Works closely with Bioventus functional partners (i.e., Regulatory Affairs, Clinical Affairs, R&D, project leaders, finance, HR) as well as clinical operations in ensuring objectives are achieved.
- Prepares the local budget and ensures effective cost controls
- Trains and provides guidance to employees on Bioventus’ requirements for clinical quality.
- Prepares reports for Senior Management documenting audit activities, metrics, findings, and resolution; raises significant issues of non-compliance.
- Travel – Domestic up to 10%
- Requires a Bachelor’s degree in a scientific discipline. A Master’s Degree or Ph.D. degree in life science, medicine, or related field would be a plus.
- A minimum of 7 years’ experience in Quality and/or Clinical with the Medical Device Industry and/or Pharma Industry.
- Strong knowledge and understanding of device and/or drug/biologic development and the clinical trial process.
- Auditing experience required.
- Knowledge of FDA Code of Federal Regulations, ICH GCP guidelines and the Clinical Research Process.
- Excellent verbal and written communication skills.
Bioventus - 2 years ago
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