Clinical Trial Assistant at Novo Nordisk

The position
As Clinical Trial Assistant, you will be responsible for providing clinical trial administration support to CDC PMs and all CRAs within the CDC country and adjacent affiliates involved in assigned clinical trials.

• Initiate, customize and maintain Investigator, confidentiality, and vendor contracts including addendums, as well as upload contracts and documents into relevant systems.
• Assist with customization of submission letters and other relevant documents and maintain trackers.
• Assist with translations of clinical trial documents, invoicing as needed, relevant systems setup, assist with managing and maintaining electronic Trial Master Files, as well as with clinical trial adverse event reporting in accordance with a sponsor, local regulatory authority, and ethics committee(s) requirements.
• Administrative duties such as travel arrangements, minute taking, meeting setup, etc for clinical trial activities and also liaising with insurance vendors for insurance policies for clinical trials.
• Complying with core Clinical Operation SOP’s, GCP, and statutory regulations to ensure the achievement of quality and safety standards as well as internal and external clinical operations timelines and KPI’s.

Qualifications

• You have a relevant academic degree or a master’s degree preferably in Life Sciences from a recognized tertiary institution.
• You have a relevant experience of a minimum of 1-2 years in a similar role preferably in the pharmaceutical and healthcare industries.
• You have excellent command over both written and spoken English and have a relevant business background.

Other important skills to be successful in this position are:

• Ability to influence and collaborate with internal and external stakeholders, as well as demonstrate cross-functional collaboration and teamwork
• Great communication skills (verbal and written) and good planning, time management, and organizational skills, including good decision-making and problem-solving ability.
• Demonstrating agility in the ways of working, being self-motivated, being patient-centric, and having a quality mindset as well as being result-oriented.
• Able to work efficiently and independently, demonstrating attention to detail and follow through.
• Excellent computer skills (especially MS Excel, Word, and PowerPoint) are necessary, as well as strong communication skills.