Part-Time GCP Clinical Compliance Consultant Job Description The Clinical Compliance Consultant will play a crucial role in supporting the development and maintenance of GCP compliance infrastructure. This includes clinical SOP development, storyboard creation for inspection readiness, and serving as a Compliance Subject Matter Expert for the clinical study team. The Consultant will work with a cross-functional team to ensure compliance with ICH-GCP, industry best practices, and applicable regulatory requirements to meet various clinical program demands. Responsibilities + Lead the development and implementation of GCP Excellence strategies in Clinical Trials to facilitate inspection readiness and process adherence. + Collaborate with and mentor study execution teams on compliant clinical trial delivery procedures, including effective mitigation and escalation strategies for inspection readiness issues. + Partner with Quality Assurance and Regulatory Affairs to ensure compliance in clinical trial delivery and align inspection readiness strategies. + Work with the Quality Assurance team to support clinical-specific QMS build/refresh, SOP development and management, CAPA management, Clinical Audit Program, RBQM procedures, and regulatory inspection activities. + Identify and implement process optimization and delivery tools to enhance study team preparedness for clinical trial delivery compliance. + Oversee vendor management and documentation, TMF operations, field study monitoring, site management, central monitoring, clinical supply management, and KPI reporting as required. + Ensure effective flow of information between internal and external stakeholders and functional leadership. + Serve as a subject matter expert for clinical compliance and contribute to or lead defined GCP initiatives, special projects, and departmental goals. + Support continuous training and education for all personnel involved in clinical trials, covering ethical considerations, patient safety, data integrity, and regulatory requirements. + Maintain up-to-date knowledge of clinical trial regulatory requirements and stay informed on changes in global regulations and guidelines. Essential Skills + 10+ years of experience in clinical operations, regulatory, and quality in the pharmaceutical or biotechnology industry. + 5+ years of experience in inspection readiness and oversight support, including participation in FDA audits. + Bachelor's degree in a relevant field such as life sciences or healthcare. + Expert knowledge of ICH-GCP, Good Documentation Practices, and various regulatory guidelines including FDA and EMA. + Proficient in Microsoft programs (Word, Excel, Outlook, PowerPoint, Teams, SharePoint) and electronic systems such as EDC, CTMS, TMF, and eQMS. + Effective communication skills (email, oral, written) and excellent time management skills. + Attention to detail and strong organizational skills with a focus on customer service. + Ability to maintain strict confidentiality of records. Pay and Benefits The pay range for this position is $87.00 - $92.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jul 4, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.