The Clinical Operations and Regulatory Affairs Placement offers broad experience across the Clinical Operations and Regulatory Affairs functions, to those completing an Industrial Placement as part of their degree course. You will support cross-functional initiatives that help deliver the UK and Ireland business strategy, while developing an understanding of how different functions work together towards shared goals. The role is suited to a curious and collaborative individual with strong communication skills, attention to detail, and the ability to think critically.
The successful candidate will be based at Alnylam's Maidenhead office, with a minimum of x2 days per week working at that location.
Summary of Key Responsibilities - Clinical Operations
- Support the organisation, maintenance and updating of clinical trial tracking systems and tools throughout a clinical study lifecycle, from study start-up through to close-out
- Assist with the development and maintenance of study management tools, monitoring tools, study manuals, training materials and presentations
- Support the scheduling of study team meetings and assist with the preparation and distribution of agendas, meeting minutes and follow-up action items.
- Set up, organise and maintain clinical trial study files and hared electronic workspaces in accordance with study requirements and company procedures
- Assist with the coordination and tracking of study training activities and associated training records
- Support the maintenance of clinical trial documentation, including filing and performing routine quality checks to ensure documents are complete and accurate
- Assist with the timely, complete and compliant filing and archiving of essential documents within the electronic Trial Master File (eTMF)
- Support the tracking of clinical trial samples, study supplies and associated documentation, working with investigator sites and external vendors as required
- Assist with the preparation, review and maintenance of study-specific documents and materials used to support clinical trial conduct
- Prepare and maintain clinical development presentations, reports, study status updates and other materials for internal and external meetings
- Collaborate with Clinical Operations, cross-functional study team members and external vendors including Contract Research Organisations to identify, communicate and help address study-related issues
- Support the Study Management team with departmental, study-specific and cross-functional projects
- Participate in Clinical Operations department meetings, study team meetings and relevant learning opportunities to develop an understanding of clinical development and clinical trial management processes
- Participate in investigator meetings, investigator site visits and other study-related activities where appropriate
- Assist with basic clinical trial financial or budget tracking activities where appropriate
Summary of Key Responsibilities - Regulatory Affairs
- Support Global and Regional Regulatory Leads with assigned programmes to contribute to global and regional regulatory strategy
- Assist with preparation, compilation, and submission, in a timely manner, of regulatory documents according to regulatory requirements. Regulatory documents may include cover letters, application forms, Health Agency meeting requests, Briefing Documents for Health Authority (HA) meetings, Clinical Trial Applications (CTAs) and components of Marketing Authorisation Applications
- Support the development, maintenance and tracking of regulatory project plans and assist regulatory activities relating to specific products or projects
- Help track and coordinate responses to regulatory authorities' questions with strict deadlines.
- Gather regulatory or competitive intelligence and regulatory precedent, to assist with formulating regulatory strategy
- Collaborate with internal departments at Alnylam and contract research organisations (CROs), etc. when required
- Support the maintenance and updating of regulatory documents, systems and databases, to ensure information is accurate, complete, and current.
- Support the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance
- Assist with the preparation of regulatory presentations, meeting materials, and training resources
- Contribute to process improvement initiatives and the development or revision of Regulatory Affairs procedures, templates, and guidance documents
- Participate in regular Regulatory Affairs Department and project team meetings, prepare meeting minutes and action items.
Supervision / training / professional development
Role-based training on company processes and procedures will be provided
As a research-based organisation, all Alnylam personnel have the opportunity to participate in educational training and seminars
Essential Qualifications
Applicants must have the right to work in the UK. Unfortunately, visa
#J-18808-Ljbffr
Clinical Operations & Regulatory Placement Student in Maidenhead employer: Alnylam Pharmaceuticals, Inc.
At Alnylam, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of biostatistics. Our Maidenhead office provides a hybrid working model, allowing for flexibility while ensuring strong team engagement. We are committed to employee growth, providing opportunities for professional development and involvement in cutting-edge clinical trials that make a meaningful impact on healthcare.
Contact Details:
Alnylam Pharmaceuticals, Inc. Recruitment Team
