Senior Clinical Research Associate
Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people living with obesity, haemophilia, growth disorders and other serious chronic diseases.
Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 80 countries and markets its products in more than 170 countries.
Novo Nordisk Romania is looking for a Senior Clinical Research Associate . In this job we offer an exciting opportunity with lots of challenges, personal and professional development with great colleagues in a positive working environment.
In this role you will have to operate as responsible for Site Management in the allocated clinical trials (feasibility, selection and initiation of sites as well as conduct and closing activities) in compliance with local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements to deliver reliable, high quality data and study subject protection. Also you will have to Establish and maintain the professional relationships with internal and external stakeholders.
General Responsibilities
Site Management:
- Prepare initiation, monitoring visits and close out visits (on-site and off-site) according to NN SOPs and prepare accurate and timely visit reports from all types of visits
- Train and guide the site staff in the protocol and trial procedures according to the training requirements stated in the monitoring plan
- Train the site staff in safety information handling in compliance with all local and company requirements, and to react to incoming safety information and initiate required procedures if necessary
- Coordinate and drive site recruitment in assigned trials in cooperation with the CDC Trial Manager
- Manage the site to meet patient recruitment rate and target
- Review and verify the source data and activities
- Identify potential risks (by using Risk Indicator Report as well as other available tools and systems) and proactively take actions to prevent or mitigate the identified risks
- Verify if the trial products are handled according to the protocol, TMM, and local requirements (supply, dispensing, accountability, reconciliation, timely reporting of temperature deviation, etc.)
- Control if data cleaning cycle timelines are met in accordance with the Data Flow Plan to meet timely DBL
- Participate in Investigators Meetings including delivering a presentation if necessary
- Check if the ITMF is properly handled by the site staff (filing and archiving the trial documentation)
- Act as the point of contact for assigned trial site(s)
- Update IMPACT on a site level in timely manner and in accordance with trial specific guidelines
- Initiate payment requests for investigators and sites
- Collaborate with Data Management/vendors to resolve sites issues related to electronic systems used in the trial
- Perform assistance and participate in audits and inspections at assigned sites and an affiliate
- Conduct site selection visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies
- Perform any other tasks assigned by the line manager
- Cooperate and communicate to CDC Trial Manager progress and critical issues that may impair trial progress
- Identify potential risks and proactively take action to prevent or mitigate
- Represent Novo Nordisk in external working groups and at conferences
Qualifications
- Master’s degree in Life Sciences or equivalent
- Experience in independent monitoring from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)
- Experience and proven successes beyond current responsibilities
- Experience in diabetes is a must, experience in Alzheimer, cardiovascular diseases is a plus.
- Ability to build and maintain strong working relationships with internal and external stakeholders
- Ability to share knowledge and train site staff
- Team oriented personality with high degree of flexibility - close collaboration with relevant roles to ensure successful of the trial deliverables
- Takes ownership of allocated trial activities to ensure timely delivery, proactively flags risks and issues and provides possible mitigations and solutions
- Excellent negotiation, communication & presentation skills
