• Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy. • Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. • Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. • Achieve company’s target cycle times for site. • May have contact with investigators for submission related activities. • May act as a key-contact at country level for either Ethical or Regulatory submission-related activities. • Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. • Assist in developing country specific Patient Information Sheet/Informed Consent form documents. • Assist with grant budgets(s) and payment schedules negotiations with sites. • Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner. • Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements • Deliver site start-up and activation work to a high standard, working closely with your team and stakeholders • Assist in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions • Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation • Maintain accurate and up-to-date records of regulatory submissions and approvals • Support study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures • Participate in study start-up meetings and provide input on regulatory requirements and timelines

• Support the management and monitor of clinical trial sites by ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. • Contribute to clinical research activities, taking responsibility for deliverables and working collaboratively. • Coordinate monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues. • Assist in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations. • Collaborate with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle. • Track site performance metrics, analyzing data, and providing reports to enhance site management efficiency. • Participate in training initiatives and mentoring junior staff to support their development in clinical trial management.

Role Description You’ll be joining our energetic and multi award-winning News team, covering Bristol and Bath. We’re the trusted local voice for millions of listeners across Greatest Hits Radio, Hits Radio, and our iconic brands including Magic Radio, Absolute Radio, and KISS. Our newsroom is collaborative, fast-paced and passionate about telling brilliant local stories. You’ll work closely with other reporters, editors and presenters who support each other, share ideas and thrive on being first to break the news. As a Multimedia Reporter, you’ll be at the forefront of breaking news across Bristol and Bath surrounding area. You’ll deliver engaging, authoritative journalism across radio, video, digital and social channels, ensuring our audiences receive accurate, balanced and compelling stories when they matter most. Your role: - Sourcing, developing and delivering breaking local news stories - Reporting live from the scene of developing stories - Producing engaging audio and video content - Planning and delivering compelling local bulletin content - Building and maintaining strong contacts across the patch - Ensuring all content is accurate, legally sound and Ofcom compliant - Supporting coverage across Bauer’s wider news network Qualifications - Recognised journalism qualification - Professional experience as a Journalist - Full UK driving licence - Strong audio and video editing skills - Knowledge of media law and Ofcom regulations - Ability to work calmly under pressure across platforms Requirements - News doesn't stick to office hours – so you will have flexibility to respond out of hours Benefits - 28 days holiday, bank holidays & 2 volunteer days to use - Access to our internal training provider – Bauer Academy - Enhanced Maternity/Adoption, Paternity and Shared Parental Leave Pay - Opportunity for flexible working - And much more! Company Description We are a media business focused on creating content that matters to millions of people across Europe. Our offering extends from print and online publishing to audio broadcasting and entertainment, alongside investments in other media related sectors. With more than 500 million copies sold each year, we are one of Europe’s largest Publishers. - We operate over 150 radio and podcast brands in nine countries - Family-owned in the 5th generation - Our workforce of 12,000 shares a common purpose: to deliver content and services that enrich people‘s everyday lives.