GCP Compliance Officer

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.

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.

• 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.
• Support external audits as GCP SME and prepare the organization for such inspections.
• 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.
• Monitor and review protocol amendments and ensure that all changes are implemented properly and consistently.
• 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.
• Support broader organization as GCP SME, support business development and operational teams in client facing situations.
• Champion the Clinigen Way principles which underpin everything we do, living those values in daily Clinigen life.

About you:

• Education: Degree educated in a science related field.
• 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. Harnessing a global network and local insight, Clinigen’s world-class team works together to impact lives everywhere. Whatever the challenge, you’ll find a way.