Are you passionate about clinical research and looking to make a significant impact in the healthcare industry? Britannia Pharmaceuticals is seeking a dedicated Clinical Trials Associate to join our dynamic team. In this role, you will be responsible for the global execution and timely delivery of assigned studies across various therapy areas, ensuring adherence to quality, budget, and regulatory standards.
Key Responsibilities:
* Study Management: Oversee execution and delivery of clinical studies according to the defined protocols while ensuring compliance with local regulations, ICH GCP, and Britannia’s standards.
* Leadership: Collaborate with the Medical Affairs Manager to drive study conduct decisions and escalate issues when needed.
* Project Coordination: Manage country and site-level activities, including site management, monitoring activities, and ensuring timely report reviews.
* Stakeholder Liaison: Be the operational point-of-contact for internal teams, CROs, and clinical site staff to facilitate effective communication and collaboration.
* Process Improvement: Identify and implement best practices, ensuring optimal performance of study teams while maintaining regulatory compliance.
* Site Selection: Assist in identifying potential study sites and conducting Site Quality Risk Assessments in collaboration with local Affiliates.
* Regulatory Submissions: Ensure timely submission of all necessary documents to Ethics Committees and Regulatory Authorities throughout the study lifecycle.
* Financial Management: Manage project-related expenses, perform budget reconciliations, and oversee site payment processes.
* Documentation Oversight: Collect and verify essential trial documents to ensure compliance with ICH GCP requirements before study initiation.
* Monitoring Activities: Coordinate monitoring from site activation to study closure, ensuring adherence to Monitoring Plans.
* Risk Management: Develop and maintain a global risk management plan to proactively identify and mitigate risks associated with sites and stakeholders.
* Meeting Coordination: Plan and lead Investigator meetings in accordance with local regulations.
Personal Specification (Skills Required)
* Education: Scientific degree or equivalent experience in life sciences, clinical research, pharmacy, or related field.
* Experience: Prior experience in clinical development, with extensive knowledge in Clinical Operations and experience managing CROs.
* Knowledge: Solid understanding of clinical research management, regulatory processes, and quality requirements.
* Strong project management and team collaboration abilities.
* Excellent written and verbal communication skills in English.
* Strong negotiation skills and effective problem-solving capabilities.
What we can offer you!
️Green Park offer 500+ events programme – free workout classes, beekeeping & more!
Group Private Medical Insurance
Cycle to Work Scheme
Electric Car Scheme – save up to 40% on the monthly cost, thanks to savings on national insurance and income tax
Long Service Awards – additional annual leave and bonus
Eye Care Vouchers
Extra Paid Days – volunteering days, study leave
Salary Sacrifice Pension Scheme
Hybrid working – we spend three days in the office, with Wednesday and Friday as working at home.
25 days of annual leave plus bank holidays. Additional leave given on your birthday month (wellbeing leave)
Free winter flu jab.
Wellbeing support through our Employee Assistance Programme and KYAN Wellbeing – offering free coaching and counselling services for you and your family.
Plus, many more employee benefits & celebration events across the year.
Application Requirements
We are regrettably unable to accept applications from candidates who do not have the right to work in the UK or require sponsorship to work in the UK.
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