Senior Manager/Associate Director, Clinical Compliance
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Senior Manager/Associate Director, Clinical Compliance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides ICH/GCP clinical compliance consultation and support to Clinical Operations and their stakeholders. Maintains current knowledge related to ICH/GCP guidelines and regulations and company standard operating procedures.
- Collaborates and develops strong relationships with personnel from Clinical Operations, Quality Assurance, and other stakeholders to facilitate and support process improvement, risk management, and inspection readiness activities.
- Engages with Research and Development, Pharmacovigilance, and Clinical Operations to proactively evaluate and mitigate GCP risks from study conceptualization through completion.
- Collaborates with Quality Assurance to ensure that Clinical Operations written standard operating procedures, forms, and templates meet the changing needs of the organization.
- Facilitates and supports inspection readiness activities in Clinical Operations. Completes Performance Health checks and supports mitigation actions through the development and revision of new tools and process improvement.
- Provides support during and following Regulatory inspections and internal audits.
- Serves as the Clinical Compliance representative for selected clinical study teams. Applies ICH/GCP guidance and clinical compliance knowledge to varying stages of clinical research.
- Identifies and escalates significant quality and compliance risks to Head Clinical Compliance. Participates in investigation and mitigation measures.
- A Bachelor's degree in a health related or scientific discipline is required.
- Must have at least eight years of pharmaceutical or biotechnology industry experience, and at least five years working in a quality assurance or clinical compliance position supporting Clinical Operations.
- Requires prior experience with Phase I-IV research studies, and with global studies submitted for IND, MAA, or other regulatory submissions.
- Experience with the interpretation and application of ICH/GCP expectations and standards to varying phases of clinical studies is required.
- Must be a strong, enthusiastic, and collaborative team member that is solution oriented. Requires the ability to work individually and within a multi-disciplinary team.
- Must possess strong written and verbal communication skills.
- Must be organized, analytical, and attentive to detail.
- Must be proactive and self-driven to achieve on time personal goals, as well as to help others achieve desired outcomes and results.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms