Principal GCP Trainer

Principal GCP Trainer page is loaded Principal GCP Trainerlocations: UK - Stevenagetime type: Full timeposted on: Posted Todayjob requisition id: JR100045 Work with us Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork - together we are ONE Autolus. Job Description: Job Title: Principal GCP TrainerReports to: Senior Director, Head of Operational TrainingDepartment: GMP TrainingHours: Monday - Friday (core office hours)Location: Stevenage About Autolus Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases. Why Autolus Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, pension and access to an employee share scheme. Our Promise Autolus is developing complex breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we've experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees. Role Summary We are seeking a highly skilled and motivated GCP (Good Clinical Practice) Trainer to join our team in Stevenage. The GCP Trainer will be responsible for developing, implementing, and maintaining training programs to ensure compliance with GCP guidelines and regulatory requirements. The ideal candidate will have a strong background in clinical research, a deep understanding of GCP, and excellent training and communication skills. Key Responsibilities Training Development: Design and develop comprehensive GCP training programs, including e-learning modules, workshops, and seminars. Training Delivery: Conduct GCP training sessions for clinical staff, and other stakeholders, both in-person and virtually. Compliance Monitoring: Ensure that you are always abreast of new CGP regulatory updates and all training materials, programs comply with current GCP guidelines, regulatory requirements, and company policies. Training Records Management: Maintain accurate records of training activities, attendance, and certification statuses. Continuous Improvement: Regularly update training programs based on the latest GCP regulations, industry best practices, and feedback from trainees. Collaboration: Work closely with the Clinical Operations, Quality Assurance, and Regulatory Affairs teams to ensure alignment of training programs with organizational goals. Audit Support: Assist in preparing for and responding to internal and external audits related to GCP training and compliance. Mentorship: Provide guidance and support to junior staff members in understanding and applying GCP principles. Demonstrated skills and competencies Experience Minimum of 7 years of experience in clinical research, with at least 3 years focused on GCP training and compliance. In-depth understanding of GCP guidelines, ICH regulations, and clinical trial processes. Excellent presentation, communication, and interpersonal skills. Ability to explain complex concepts in an accessible manner. GCP certification or equivalent is highly desirable. Proficiency with e-learning platforms and Microsoft Office Suite. Experience with Learning Management Systems (LMS) is a plus. Strong organizational skills, attention to detail, and a commitment to continuous improvement. Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred Autolus Leadership Behaviours Clarify direction and inspire; Using good judgement to set clear and compelling goals that show your team how their work contributes to our purpose and strategy Deliver goals and plans; Creating joint plans with your team to deliver your goals, holding yourself and others accountable for delivering quality results Work collaboratively; Cultivating a network of relationships across the organisation and building high performing teams based on mutual trust and respect Optimise potential; Creating a healthy, engaged and empowered working environment that invests in people and their development. Role Model our values; Acting as a role model ensuring everything you do is in line with our values of respect, integrity, focus and breakthroughAutolus' success is driven by equality and inclusion; we believe all voices are of equal value and must be heard.Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry. Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.