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- Tasks: Lead GCP compliance processes and ensure adherence to regulations.
- Company: Clinigen is a global specialty pharmaceutical company focused on delivering vital medicines.
- Benefits: Flexible working options, supportive team culture, and opportunities for professional growth.
- Why this job: Make a real impact in global healthcare while working in a dynamic environment.
- Qualifications: 3-5 years of experience in GCP compliance with strong analytical and communication skills.
- Other info: Remote work available, but regular travel to Weybridge is required.
The predicted salary is between 36000 - 60000 £ per year.
Do you want to work in a motivating, supportive environment where you help patients across the world get access to life-saving medicine? If so, we want to hear from you.
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses, operating in complex global regulatory environments, to ensure that vital medicines are delivered, securely, on time, and wherever they are needed in the world. Pathfinders for innovative medicine, Clinigen has a vision: a world where access to medicine is global by design.
As Clinigen’s GCP Compliance Officer you’ll take responsibility for defining and monitoring processes ensuring that the organisation adheres to appropriate GCP standards. By overseeing compliance with regulatory requirements, you’ll identify potential compliance risks and implement strategies to mitigate them. This role includes monitoring and reviewing compliance programmes, conducting audits, providing guidance and training, and ensuring proper reporting practices.
Key Responsibilities:- Lead the creation, implementation, and update of appropriate GCP compliance policies and procedures.
- Review and understand all relevant GCP guidelines to ensure the activities follow industry standards.
- Ensure adherence to international regulations, EMA regulations, and local health authority requirements.
- Develop and deliver training programs to employees on GCP, including legal regulations, company policies, and ethical standards, ensuring continuous improvement education to stay updated with GCP regulations.
- Identify and evaluate GCP compliance risks and develop strategies to minimize exposure to regulatory and reputational risks.
- Conduct regular audits and reviews of business operations to ensure adherence to GCP guidelines, SOPs and applicable regulations.
- Drive any monitoring clinical trial sites to ensure that they follow proper documentation, reporting, and ethical practices in the recruitment and treatment of participants.
- Lead investigation of non-compliance issues and implement corrective and preventive actions (CAPAs) to address any deviations from GCP guidelines.
- Ensure proper documentation is maintained, including source documents, trial master files (TMF), and regulatory submissions, in line with GCP requirements.
- Ensure submission of trial protocols and informed consent documents to the appropriate Ethics Committees (EC) or IRBs for approval prior to initiation.
- Ensure appropriate oversight by the Ethics Committee/IRB during the clinical trial extension, including periodic reviews and approvals of amendments.
- Liaise with regulatory agencies to ensure compliance with applicable GCP regulations and respond to queries or inspections.
About you:
- Minimum of 3-5 years of experience in a related field, with solid knowledge of GCP principles and practices.
- Strong knowledge of relevant laws, regulations, and industry standards.
- Ability to assess risk and implement effective controls.
- Excellent communication, analytical, and organizational skills.
- Integrity and ethical decision-making.
- Attention to detail.
- Problem-solving skills.
- Strong communication and interpersonal skills.
- Ability to work independently and in a team setting.
You can be based anywhere in the UK for this, but you will need to be able to travel to Weybridge on a regular basis.
Headquartered in the UK, their team of over 1000 people are based across Derbyshire and Surrey, with global offices in the US, EU, Australia, New Zealand, Japan, Hong Kong, South Africa, and Southeast Asia. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued growth.
As pathfinders, they’re experts at navigating complexity and accelerating access to medicines to those that need them, whether in clinical trials, early access programmes, or long-term commercialisation (licensed and unlicensed pathways). Dedicated, open and collaborative, Clinigen guide their pharmaceutical and biotechnology clients at every step helping them to reach their goals and overcome practical, regulatory and geographical obstacles. Whatever the challenge, you’ll find a way.
GCP Compliance Manager employer: Clinigen
Contact Detail:
Clinigen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GCP Compliance Manager
✨Tip Number 1
Familiarise yourself with the latest GCP guidelines and regulations. This will not only help you understand the role better but also allow you to engage in informed discussions during interviews, showcasing your expertise and commitment to compliance.
✨Tip Number 2
Network with professionals in the pharmaceutical and compliance sectors. Attend industry conferences or webinars where you can meet people who work at Clinigen or similar companies. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled compliance issues in the past. Think about challenges you've faced, the actions you took, and the outcomes. This will demonstrate your problem-solving skills and ability to implement effective controls.
✨Tip Number 4
Showcase your training and mentoring experience. Since the role involves developing and delivering training programs, be ready to discuss any previous experiences where you've educated others on compliance or regulatory standards, highlighting your communication skills.
We think you need these skills to ace GCP Compliance Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the GCP Compliance Manager position. Understand the key responsibilities and required skills, so you can tailor your application accordingly.
Tailor Your CV: Customise your CV to highlight relevant experience in GCP compliance, regulatory requirements, and any training or auditing roles you've held. Use specific examples that demonstrate your knowledge of GCP principles and practices.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the role. Mention your experience with compliance policies, risk assessment, and training programmes. Show enthusiasm for Clinigen's mission and how you can contribute to their vision.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a compliance role.
How to prepare for a job interview at Clinigen
✨Know Your GCP Standards
Make sure you have a solid understanding of Good Clinical Practice (GCP) standards. Be prepared to discuss how these guidelines apply to the role and how you've implemented them in your previous positions.
✨Demonstrate Risk Assessment Skills
Be ready to talk about your experience in identifying compliance risks and the strategies you've developed to mitigate them. Use specific examples to showcase your analytical skills and problem-solving abilities.
✨Showcase Your Training Experience
Since the role involves developing and delivering training programmes, highlight any relevant experience you have in this area. Discuss how you ensure continuous improvement and keep teams updated with GCP regulations.
✨Prepare for Compliance Audits
Familiarise yourself with the audit process and be prepared to discuss how you've conducted audits in the past. Emphasise your attention to detail and how you handle non-compliance issues, including implementing corrective actions.
