Exciting opportunity to join as Senior Clinical Trial Manager!

We are seeking a Senior Clinical Trial Manager (SrCTM) who will be responsible for the overall planning, management, conduct and oversight of assigned clinical trials sponsored by Vaccibody. The individual will be leading the cross-functional trial team with internal and external key members. In this role, you may act as Clinical Operations Lead for dedicated projects and be part of the cross-functional project team and clinical development team, accountable for all aspects related to clinical trial management including management of trials budgets and clinical development planning.

About the role

The SrCTM will be the primary liaison between Vaccibody, CROs and other vendors, managing all aspects from Start-up to close-out activities in assigned clinical trials. Other responsibilities will include writing/providing input to clinical documentation such as clinical trial protocols, protocol amendments, clinical study reports and relevant submission documents as well as being overall responsible for trial oversight activities in collaboration with trial team members. In addition, contribution to Vaccibody’s Quality Management System focusing on clinical trial related SOPs are expected from this role. Furthermore, you will guide and mentor colleagues within area of own area of expertise, as well as support competency building within clinical trial aspects across projects and being the expert on clinical trial conduct in relevant cross functional teams.

The responsibilities of this postion include:

• Managing a cross-functional clinical trial team with shared objectives and deliverables for the assigned trial(s)
• Contributing to and ensuring the clinical development planning as a key contributor and key member of cross-functional Project Team
•  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
• Ensuring good communication and information among all stakeholders within the matrix organization
• Provide trial updates related to progress, milestones, risks and mitigations where relevant
• 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

SrCTM will report to Head of Clinical Operations.

Key qualifications:

• Master or PhD degree within medical, biological, pharmaceutical science or equivalent
• Minimum 5 years of experience in clinical research/clinical operations
• Experience from working in a global or regional organization within a pharmaceutical company, CRO or biotech company
• Expertise in clinical development planning focused on early phase programs and preferably adaptive clinical trial designs
• Experience within oncology and/or vaccines preferred
• Profound knowledge of GCP and regulatory procedures and guidelines
• Experience with clinical trial submission activities to regulatory authorities and Ethics Committees
• English fluency, both oral and written is required

Location: Oslo Science park/Forskningsparken, Norway/Copenhagen, Denmark.

Deadline: 08.12.2021. Applications will be reviewed on a rolling basis. We look forward to receive your application! Should you have any further questions, please reach out to us. Applications sent by e-mail will not be accepted. 

Who are we looking for?

When hiring new employees, we also look for the individuals who are inspired by Vaccibody’s entrepreneurial spirit and whom we think would be a good fit with our collaborative and inclusive company culture. We believe that you are driven by an eagerness to learn, you are proactive and not afraid of facing new challenges. You are ambitious, felxible, and have an appetite for working in a energetic start-up company to “get things done”. 

As Sr CTM, you bring excellent clinical trial management skills and expertise, and have a talent for project leadership. As a person, you are flexible and thrive working in a dynamic environment where you juggle several projects at once. You appreciate working in several cross-functional team structures, and you are skilled in cooperating with multiple stakeholders and various team members. 

Why join our Vaccibody team?

At Vaccibody, we offer a fun and dynamic international working environment. The people are at the heart of our organization, which is why we always keep striving to offer a workplace where we cheer each other on and find motivation. Your skills and competencies are unique and to ensure continued development our aspiration is to provide you with good opportunities for personal growth. We care about each other.