Clinical Research Associate

Your new role

The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring, and reporting of clinical trials. The In-House Clinical Research Associate partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; investigative site recruitment & feasibility; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.  The Clinical Research Associate, based on the eastern seaboard of Australia and will report to the Director, Clinical Line Management in the US.

Your future team

Your future team will be a dynamic and innovative group of professionals dedicated to driving excellence in the pharmaceutical industry. As part of the clinical US team, working remotely in Australia, you will liaise with the Lundbeck, Australian and global medical teams to assist in the preparatory work for the launch of new therapeutic agents. 

What you bring to the team

To succeed in the role, you will need:
•    Bachelor’s degree, preferred 
•    5+ years of relevant and progressive experience with clinical trials 
•    High level of proficiency in English 
•    Can work a schedule that often includes early morning calls to communicate with the California headquarters 
•    Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes, protocols, and medical terminology 
•    Prior experience in management and monitoring of CRO and investigative sites, preferred
•    Experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability
•    Strong written and verbal communication and computer literacy (e.g., Microsoft Word, Excel, PowerPoint, Outlook); strong experience utilizing CTMS, EDC, TMS, and related software 
•    Motivated to work in a fast-paced, high-accountability environment 
•    Experience with bio-samples, storage of 3rd party data, and preferred 
•    Travel up to 35%

Preferred Experience

•    Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations 

Our promise to you  

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being. 

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion. 

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you! 
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

Australian residents only to apply.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).
#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.