Jobs 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.

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Your Key Responsibilities Will Include

As a Project Manager in CDC-ZA you will manage assigned clinical trials, lead the CDC trial teams to ensure high quality execution of the trials and deliverables within the CDC.

• Planning, executing, coordinating tasks and communicating between relevant roles, such as CTA and CRAs and global trial management, to facilitate the progress of the trial.
• Proactive risk identification and executing mitigation plans.
• Responsibility for trial budgets: preparation and tracking in the CDC Performing Monitoring Visit Report review, conducting co-monitoring visits across the CDC, as well as audit/inspection readiness, audit/inspection action plans and follow up for assigned clinical trials in CDC.
• Execution of recruitment and retention plans at the CDC level .

Qualifications

In order to be considered, you need to hold:

• A Bachelor/Master degree in Life sciences or similar.
• Minimum of 3 years of experience in operational aspects of planning and conducting clinical trials, with at least some experience in leading clinical trials – ideally as a Clinical Project Manager, but we can also consider Senior or Lead CRAs with relevant experience.
• Work experience previously as CRA will be preferred.
• Proficiency in both oral and written English is essential.