Manager, Clinical Operations, International Jobs

Cabaletta Bio Inc

Location:
Germany; Switzerland

Category:
Research and Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. Reporting to the Executive Director, Clinical Operations, International, this role will be responsible for providing oversight and support to clinical operations vendors and teams in planning, execution, data management, and close-out of assigned clinical studies with a focus on quality and compliance. They will be responsible for clinical oversight and will be a key contributor to the clinical development planning and analysis and reporting of data for assigned programs, including applying their experience to the development of protocols, data management plans, statistical analysis plans, and safety reporting plans. The Manager/Sr. Manager, Clinical Operations, International will also contribute to continual process improvement initiatives within the Clinical Operations department in the areas of study management, information and tracking systems, metrics, and the development/enhancement of clinical operations SOPs.

Job Responsibility:

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms
Initiate and manage study-level timelines and enrollment, including communication to internal and external team members on deliverables
Attend and present at study initiation visits (SIVs) and other site trainings/meetings
Serve as escalation point for site issues
Oversee monitoring activities, including report review
Support site supply management (e.g. lab kits, site tools, paper scales, thermometers, etc.)
Perform periodic review of clinical data, quality metrics and study deviations
Review clinical monitoring reports to ensure timely completion and identification of issues
Manage laboratory samples to be sent to vendors in order to meet trial deliverables
Participate in testing of clinical trial systems/databases (i.e. UAT)
Work with finance team to review and approve study and site budgets and budget templates
Provide critical thinking and escalation when issues arise during execution of clinical studies
Act as a liaison with other internal and external functional departments including quality assurance, data management, document management, regulatory, safety, translational research, clinical supply management, etc
Ensure high quality and compliance of work products to internal SOPs and external regulations to avoid unacceptable risk to the projects and functional area
Use project management analytical methods to assess progress and risks for assigned studies
Oversee, lead and train study-specific team members as needed
Provide mentoring to assigned contract and permanent Clinical Operations staff (e.g., CRAs and CTAs)
Support Clinical Operations departmental projects including continual process improvement initiatives and SOP development
Perform other duties as needed

Requirements:

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management
CRA or CRA oversight experience in European sites preferred
Proven record of site and investigator/KOL interaction
General knowledge of other clinical trial functional areas and their respective deliverables including, regulatory affairs, data management, safety, medical monitoring, and medical writing
Strong attention to detail, good organizational and communication skills
Ability to work independently and interact with senior management on a regular basis
Demonstrated leadership skills
Strong problem-solving skills with a solution-focused approach
Proficient with project management tools and analysis of metrics
Ability to travel to clinical sites as needed
Strong team orientation and passion for continuous self-development

Nice to have:

Cell therapy experience
Working proficiency in additional European languages
CRA or CRA oversight experience in European sites

What we offer:

health and retirement
PTO
stock option plans

Additional Information:

Job Posted:
December 06, 2025

Work Type:

Remote work

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Manager, Clinical Operations, International