Clinical Trial And Regulatory Manager

Clinical Trial and Regulatory Manager

We are seeking a dedicated and experienced Clinical Trial and Regulatory Manager to join our dynamic team in the field of liver cancer diagnostics. The ideal candidate will be responsible for overseeing the planning, execution, and monitoring of one of our company’s pivotal clinical studies and ensuring that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines. Additionally, the Clinical Trial and Regulatory Manager will manage and work with third party consultants to manage FDA communications related to the study, as well as collaborate with R&D and site personnel to ensure successful enrollment and timing targets.

DUTIES & RESPONSIBILITIES

• Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
• Ensuring adherence and compliance to the assigned protocols at their respective sites.
• Managing all site-related agreements and negotiating/preparing site budgets.
• Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
• Creating, revising, and finalizing documentation related to the clinical study, including but not limited to study protocol(s), patient informed consent forms, training materials, and other required source documents for the assigned protocols.
• Ensuring that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
• Working with third party consultants as needed to manage related regulatory submissions and/or communications with the FDA.
• Managing IRB-related documentation and required approvals.
• Completing all the relevant training prior to study-start and on a continued basis in a timely manner.
• Submitting required administrative paperwork per company timelines.
• Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
• Being prepared for and available at all required company meetings.
• Occasionally attending out-of-town Investigator Meetings.
• Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
• Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C.
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all relevant guidance documents, and assigned study protocol(s).

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor's degree required

Experience:

• Minimum of 5 years experience in Clinical Research
• Supervisory role in designing, leading, and executing clinical study independently required
• Experience with FDA communications/submissions, including Q-subs, 510k, and/or de novo submissions preferred.
• Diagnostics-related clinical study experience preferred

Credentials:

• ACRP or equivalent certification is preferred

Knowledge and Skills:

• Must have strong written and communication skills.
• Goals-driven while continuously maintaining quality.
• Must be detailed-oriented, proactive, and able to take initiative.