Clinical Operations Lead

Clinical Operations LeadLocation: Welwyn Garden CityContract Length: 6 monthsHybrid: 2-3 days in officeDaily Rate: £339.27 - £500.00 InsideIR35Our client, a leading organisation within the pharmaceutical industry, is seeking a highly skilled Clinical Operations Lead to join their clinical research team. This is an exciting opportunity for an experienced professional to lead study start-up activities, support regulatory submissions, and drive the successful activation of clinical trial sites across the UK.Key Responsibilities:Lead country-level study start-up activities to support the successful delivery of clinical trials across multiple therapeutic areas.Oversee clinical trial submissions and approvals, including interactions with MHRA, HRA, Ethics Committees and other regulatory bodies.Drive site activation activities, ensuring studies are initiated in line with project timelines and regulatory requirements.Collaborate with global study teams, CROs, investigators and site personnel to support efficient study start-up and delivery.Manage study amendments throughout the clinical trial life cycle, ensuring compliance with applicable regulations and internal procedures.Support site contract and budget activities, including negotiation, execution and ongoing management.Maintain accurate study documentation and ensure adherence to ICH-GCP, EU CTR and other relevant regulatory requirements.Proactively identify operational risks and implement mitigation strategies to support study ..... full job details .....