We are looking for a new Clinical Trial Manager to join our exciting journey! The Clinical Trial Manager (CTM) will be responsible for the overall planning, management, execution and budget phases.
Job title: Clinical Trial Manager
Application deadline: Applicants will be reviewed on an ongoing basis
Location: Lyngby, Denmark or Oslo, Norway
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.

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 organization within a pharmaceutical company, CRO or biotech company
• Excellent clinical trial management skills and expertise
• Experience within oncology and/or vaccines preferred
• Experience with adaptive clinical trial designs preferred
• Profound knowledge of GCP and regulatory procedures and guidelines

WHO ARE WE LOOKING FOR?

When hiring new employees, we look for people inspired by our technology and 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 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. A career at Nykode Therapeutics 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.

THE APPLICATION PROCESS

We see diversity as a strength and encourage all interested candidates regardless of personal background to apply. Applications will be reviewed on a rolling basis. Apply via the link and please note that we do not accept applications by email.
Should you have any further questions regarding the position, do not hesitate to reach out to: Gertrud Koefoed Rasmussen, VP, Head of Development Operations, gkrasmussen@nykode.com
We are looking forward to receiving your application

• 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 and guidelines
• 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 Head of Development Operations