Senior Clinical Trial Manager

About Us

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making and we take pride in our collaborative working environment! In February 2025, the European Commission approved Egetis’ Emcitate® (tiratricol) as the first and only treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome). In March 2026, the U.S. FDA accepted the filing of Egetis’ New Drug Application (NDA) for Emcitate® (tiratricol) for the treatment of MCT8 deficiency and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is September 28, 2026.  As a courageous, committed, and collaborative organization, we are seeking to grow our team to drive success both in the pre-launch and post launch phases of our anticipated U.S. approval. For more information, please visit our website at www.egetis.com or follow us on LinkedIn and Facebook  

Our Values  

• Courageous - Challenge the status quo for the benefit of the patient 
• Committed - Operate with high ethical standards through an efficient organization to deliver top quality results  
• Collaborative - Through trust, work seamlessly across functions and with external partners  

As a Senior Clinical Trial Manager you will focus on project management and sponsor oversight. You will report to the Head Clinical Operations. You will work closely with the Clinical Operation and Clinical Development teams but also with colleagues in other R&D functions.  
Egetis headquarters is in Stockholm, Sweden, and we welcome applications from candidates based anywhere within the Central European timezone (CET/CEST) with no relocation required. Stockholm-based or near-by area applicants are equally welcome to work from our office. 

Requirements

Qualifications 

• Bachelor's degree or equivalent (any discipline). A background in life sciences is a plus, but not a requirement. Broad experience as a Clinical Trial Manager and thereby able to work autonomously to a large extent
• Experience from working in Phase II-III trials
• Experience in rare diseases and small biotech is a plus
• Good knowledge and understanding of clinical trials and ICH-GCP
• Medical and scientific writing skills
• Highly proficient in spoken and written English
• Experience working at a CRO is considered an advantage
• NDA submission experience
• Experience with FDA/ EMA inspections or other authorities is a bonus

 
Competencies 

• Stakeholder Management - Builds productive relationships with internal and external stakeholders and manages interactions in a professional and constructive manner.
• Proactive Problem Solving - Identifies risks and issues early, takes initiative, and drives solutions forward.
• Ownership and Accountability - Takes responsibility for deliverables, follows through on commitments, and delivers high-quality work.
• Planning and Execution - Prioritizes effectively, manages multiple activities simultaneously, and delivers according to agreed timelines.
• Collaboration - Works effectively across functions, shares knowledge, and contributes to a positive team environment.
• Adaptability - Remains effective in changing circumstances and adjusts quickly to new priorities and business needs.
• Communication - Communicates clearly and concisely, ensuring alignment and timely escalation of issues when needed.

Responsibilities

• Oversee and follow up on activities of the contracted External Service Providers (ESPs) i.e. Clinical Research Organization (CRO) and other clinical vendors to ensure that obligations are fulfilled. This includes management and oversight of scope, budget, timelines, resources, and risks, as well as identification of changes in scope when applicable
• Perform and document sponsor oversight activities, such as reviewing monitoring reports, tracking study metrics, reviewing submission packages, and follow-up on deliverables from ESPs.
• Support writing and reviewing study-specific documents, such as CSPs, ICFs, monitoring plans, data management plan, risk management plan, study specific procedural manuals etc.
• Primary contact with assigned counterparts at ESPs.
• Provide clinical study status updates and escalate issues.
• Support organization and attend Investigator Meetings and site meetings when needed.
• Support investigator/site selection process.
• Support internal audit and inspection activities when applicable.
• Support regulatory activities.
• Support Clinical Trial Safety management.
• Support monitors and investigator site staff if needed e.g.,study-specific training, co-monitoring, etc.
• Support selection of ESPs, attend bid defense meetings.
• Ensure that all clinical activities are compliant with ICH-GCP, regulatory requirements and company SOPs. Develop and update company procedures when needed

 
Principal interfaces 
Internal: R&D functions in-house  
External: CROs, vendors