The Clinical Trial Administrator acts in a pivotal role in relation to other roles and teams in Clinical Operations by being responsible for administrative and logistical activities related to clinical trials, with special focus on clinical trial master files (TMFs) for Nykode sponsored clinical trials and processes related thereto, CRO oversight and process optimization.
The role
The CTA is a member of clinical trial teams and will be responsible for setting up Nykode TMF plans and for supporting the TMF filing process across the organization as well as handling administrative and logistical activities related to preparation, conduct and completion of clinical trials. Nykode relies on CROs to conduct clinical trials and for hosting main parts of the TMFs. Responsibilities and activities you would be engaged in for this position include, but are not limited to:
- Provides general administrative support to Clinical Operations roles and teams
- Supports optimization of current processes and/or introduction of new or modified processes
- Maintain and track relevant documentation for clinical trials
- Member of clinical trial teams
- Preparation of Trial Master File plan in collaboration with CTM, CRO and other relevant internal stakeholders
- Responsible for deliverables related to Trial Master File quality checks and final archiving and related relevant CRO oversight activities
- Support in developing clinical trial related documents such as protocol, IB and CSR focusing on administrative completeness
- Assist in developing presentation material
- Creates meeting agendas and meetings minutes
- Responsible for tracking of purchase orders and reviewing invoices for accuracy
- Archiving of (e)TMFs
- In collaboration with other CTA(s) being the point of contact for TMF filing questions
The role will report to Head of Development Operations.
Who are we looking for?
When hiring new employees, we are looking for individuals who are inspired by the Nykode technology and our quest to unlock the future of medicine. We are eager to hire people who seek out environments that offer creative challenges and provide growth opportunities. If you feel at home in a highly collaborative, flexible, and courageous company culture, Nykode might be the right place for you.
For this position, we are looking for someone who thrives in an energetic work environment. You are skilled in collaborating with various stakeholders; and you bring your analytical and organisational skills to the role. You are an experienced user of Microsoft 365 (i.e., Excel and PowerPoint); GCP compliant electronic document management systems; and have knowledge about oversight activities and TMF requirements. Working in teams bring you joy, but you also like to work independently.
Education and Training
- Degree in health science, nursing, pharmacy or similar
- Minimum three years of professional experience in a similar role in a pharma company or biotech
- Extensive knowledge of GCP and regulatory requirements for document management
- Experience from working with the DIA reference model
- English fluencey is required
- Excellent writing skills
Applications will be reviewed on a rolling basis with a deadline on 31. May 2022
We are looking forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: recruitment@nykode.com
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