Clinical Research Associate / Sr. Clinical Research Associate

Job description

Your impact begins here As a Clinical Research Associate / Sr. Clinical Research Associate, you will make sure the clinical trials at your sites run safely, compliantly and to plan. You will be the primary link between Novo, investigators and study teams, using risk-based monitoring to spot issues early and protect data integrity. Every visit you lead, every discrepancy you resolve and every site team you train helps keep trials on track – and protects the safety and rights of the people taking part. What you’ll bring You know what good trial conduct looks like at site level, and you take ownership of quality. You will bring: A bachelor’s degree, at minimum, in Life Sciences or a related field. 5+ years’ experience in clinical trial monitoring or a relevant pharmaceutical industry or CRO role. Strong knowledge of ICH-GCP, regulatory requirements and clinical trial methodology, with a track record of high-quality, compliant trial execution. Excellent communication and stakeholder management skills, and the ability to build strong relationships at all levels. Strong organisational, time and project management skills, so you can manage multiple sites and priorities with attention to detail. Sound problem-solving and decision-making, including proactive risk identification and mitigation. Confidence with EDC, CTMS, eTMF and other clinical trial software, and openness to new tools and better ways of working. Confidence working independently and as part of a team in a dynamic environment. Flexibility to travel as required. Useful, but not essential: Experience mentoring less experienced CRAs or acting as a lead CRA, and managing complex trials across all phases of study conduct – particularly relevant if you are applying at Sr. CRA level. What you’ll do You will oversee and manage your assigned clinical trial sites from start-up to inspection readiness, keeping quality, timelines and participant safety in focus. You will: Serve as the primary liaison between Novo, clinical sites and cross-functional study teams, conducting on-site and remote monitoring visits in line with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements. Protect patient safety and data integrity by monitoring site data, resolving discrepancies and managing adverse events, while meeting data cleaning timelines set out in the Data Flow Plan. Drive risk-based quality management (RBQM), identifying, assessing and mitigating risks throughout study conduct. Oversee site performance, recruitment, retention and data collection, and resolve site-level issues before they affect timelines or quality. Manage investigational medicinal product (IMP), supplies, equipment and essential documents, including the Investigator Trial Master File, and keep sites inspection-ready. Lead site training on protocols, procedures and systems, and share site insights that inform protocol updates, patient engagement initiatives and operational planning. At Sr. CRA level, you will also act as a role model and recognised resource in the local clinical team, mentor less experienced CRAs, and manage complex trials and operational challenges with a high degree of independence. You may act as lead CRA, take on a partial trial manager role in a specific trial, and represent the local clinical organisation in meetings and working groups, as agreed with your line manager. Who you’ll work with You will join the local clinical team in International Operations, where colleagues work across markets to serve people around the world and help improve health at scale. [Insert team name, size, line manager and country scope.] Your closest partners will be investigators and site staff at your assigned sites. Inside Novo, you will work with Trial Managers, Vendor Managers, the Study Start-up team and Clinical Trial Administrators – with the last two, you will collect the essential documents needed for ‘Green Light’ readiness and coordinate supplies. Investigator meetings, CRA training sessions and trial meetings keep everyone aligned, so studies move forward with clarity and speed. What you can expect here You will be trusted to own your sites and use your judgement. You will be encouraged to raise risks early, give and ask for honest feedback, and share site insights so trials and processes keep improving. You will grow through hands-on trial experience, CRA training sessions and learning from colleagues – and, as your expertise builds, through mentoring others and taking on lead roles. You will work to clear standards that never compromise on patient safety, in a team that supports each other and raises the bar every day. Start now Your impact begins today. If you are ready to bring quality, clarity and care to every site you manage, apply for the Clinical Research Associate / Sr. Clinical Research Associate role by [insert application deadline]. Please indicate in your application which level you are applying for.