Open position for a Clinical Trial Manager to join our team at Nykode!
- Nykode Therapeutics
- Clinical Trial Manager
Our Medical team at Nykode are now looking for a Clinical Trial Manager! The Clinical Trial Manager (CTM) will be responsible for the overall planning, management, conduct and oversight of assigned clinical trials in Nykode.
Job Title: Clinical Trial Manager
Application deadline: 15.08.2022 - Applications will be reviewed after the deadline.
Location: Oslo, Norway / Copenhagen, Denmark
In this role, you will lead the cross-functional clinical trial team with overall responsibility for the activities in ongoing and planned clinical trials.
You will be primary liaison between Nykode, CROs and other vendors, managing all aspects from Start-up to close-out activities in assigned clinical trials, and will be leading the cross-functional study team with internal and external key members.
Other responsibilities will include writing/providing input to clinical documentation such as clinical trial protocols, protocol amendments, clinical study reports and relevant submission documents. The Clinical Trial Manager is overall responsible for oversight activities in collaboration with trial team members and for the documentation thereof. In addition, contribution to Nykode’s Quality Management System focusing on clinical trial related SOPs are expected from this role.
The responsibilities of the position include but are not limited to:
- Responsible for all phases and aspects of clinical trial conduct; planning, start up, execution, follow-up, timelines and budget
- Managing a cross-functional clinical trial team with shared objectives and deliverables for the assigned trial(s)
- Ensure that assigned clinical trials are conducted in compliance with GCP, relevant SOPs and regulatory requirements
- Ensuring that clinical trial deliverables meet the agreed quality levels and KPIs
- Responsible for CRO collaboration, oversight and adherence to scope of work within agreed timelines and budget
- Contribute to planning, design, writing and review clinical trial protocols, amendments and clinical study reports
- Clinical trial oversight activities to ensure adherence with clinical trial regulations
- Update internal stakeholders on trial related milestones, risks and action plans
- Write input to and review clinical documentation created in collaboration with CRO or internal team members needed for submissions of CTAs/IND to Regulatory Authorities/ Ethics Committees
- Maintaining a specific and up to date knowledge in the area of setting up and conducting clinical trials
The role will report to Team Lead Clinical Operations.
Education and experience
- Master or PhD degree within medical, biological, pharmaceutical science or equivalent
- Minimum 3 years of experience in clinical research/clinical operations
- Project leadership, cross-functional teamwork, and an ability to cooperate with multiple stakeholders
- Experience from working in a global or regional organization within a pharmaceutical company, CRO or biotech company
Who are we looking for?
When hiring new employees, we look for the people who are inspired by our quest to unlock the future of medicine. We embrace new ways of thinking and doing. When growing and building our teams, we look for the people inspired by our mission and those seeking to join a collaborative and value-based company culture. An eagerness to learn and continuously develop is a core characteristic of our highly skilled and competent individuals. Life at Nykode is an opportunity to take part in the journey to push the boundaries of human advancement. Our work is meaningful, and we care. We care about the patients, and we care about each other.
In the role as Clinical Trial Manager, we are looking for a person with excellent clinical trial management skills and expertise. It is prefered that the person has experience within oncology and/or vaccines as well as experiemce from working with adaptive clinical trial designs. Other skills we are looking for include:
- Profound knowledge of GCP and regulatory procedures and guidelines
- Excellent communication skills both in written and verbal form
- English fluency is required
The application process
Applications will be reviewed after the deadline. We are looking forward to receiving your application! Please note that we do not accept applications by mail. Should you have any further questions regarding the position, reach out to us.
Nykode Therapeutics is a company driven to create positive change and reduce the impact of disease on people's lives.
Nykode Therapeutics is an Oslo-based clinical-stage biopharmaceutical platform company founded in 2006. Our bold aim is to generate game-changing therapeutics to treat cancers and infectious diseases with a high unmet medical need.
With our unique and innovative modular vaccine technology, we’re specifically targeting antigens to Antigen Presenting Cells, which are essential for inducing rapid, strong and long-lasting immune responses.
- Gaustadalléen 21, 0349 Oslo
- Forskning, utdanning og vitenskap
Clinical trial manager, Kliniske studier, Clinical, Medical, Nykode
|Sist endret||16. jun. 2022 17:52|