Job Title
Clinical Trials Manager
About the Role:
We are at an exciting and fast-paced stage of the company's growth and are looking for a proactive and dedicated Clinical Trials Manager to join our collaborative and interdisciplinary team. The successful candidate will work closely with cross-functional teams, including R&D, regulatory affairs, and product development, to ensure that clinical studies are conducted efficiently, in compliance with applicable regulations, and deliver high-quality data to support regulatory submissions and market access.
Key Responsibilities:
1. Planning and preparation for clinical studies:
* Lead the planning and execution of clinical trials in accordance with UK and EU medical device regulations, Good Clinical Practice, SOPs, and any other applicable guidelines.
* Develop detailed project plans, including timelines, budgets, and resource allocation.
* Manage the preparation and submission of clinical trial protocols and regulatory documents
2. Managing the execution of clinical studies:
* Manage and establish collaborations with clinical trial sites
* Interact with the internal team, the Sponsor, study sites, and third-party vendors. Providing cross-functional oversight of internal project team members and deliverables
* Work closely with study PIs to achieve KPIs in relation to patient recruitment, screening and quality
* Serve as primary sponsor contact for operational project-specific issues and study deliverables
* Develop operational project plans
* Manage trial budgets, resources, risk assessment and execution
* Responsible for management of study vendors, sites, and data
* Communication and collaboration, ensuring regular updates to 52North senior leadership on trial progress and milestones, preparing and presenting trial status reports.
* Support the writing of clinical manuscripts for publication
* Prepare abstracts, power-point presentations and posters for presentations to external stakeholders and submission to scientific conferences.
Qualifications and Experience:
* Bachelor's degree in a health and life science-related field; Advanced degree in a health or life science-related field preferred
* Minimum of 2 years of experience in managing clinical trials
* Proven clinical trial experience, clinical trial management; and operations for commercial trials
* Evidence of preparing regulatory and ethics submissions, IRAS submissions, writing/amending Clinical Investigation Plans, Patient Information Forms and electronic Case Report Forms, plus other relevant trial management documentation.
* Good Clinical Practice (GCP) training
* Ability to work well within a team within a fast-paced environment
* Excellent project management skills within clinical trial management
* Excellent communication skills, both verbal and written, with the ability to interact effectively with internal teams, clinical sites, and regulatory bodies.
* Strong problem-solving skills and ability to adapt to a fast-paced, changing environment.
* Attention to detail and strong organisational skills.