Senior Clinical Trial Manager Job at Life Science Talent (København og omegn)

Senior Clinical Trial Manager

Life Science Talent

Location:
Denmark , København og omegn

Category:
Research and Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

At Hemab you will join a clinical-stage biotech company on an exciting journey to build the ultimate clotting company focusing on high unmet need for patients suffering from neglected bleeding and thrombotic disorders. Based in Cambridge, US and Copenhagen, Denmark, Hemab will offer a great working environment, where we believe that a balanced and varied working life can go hand in hand with high quality drug discovery from idea to market. As a Sr. CTM in Clinical Operations at Hemab, you will be a major contributor to the successful execution of clinical trials, which is key to building and maintaining relationships with Investigators and other study site personnel, CRAs, CROs, team members, and study vendors. Based on a thorough understanding of the mechanics of conducting clinical trials, you will closely supervise all aspects of study operations, including clinical project management, site management, and vendor management.

Job Responsibility:

Manage CRO study team(s), clinical sites, laboratory vendor(s), and other outsourced work on assigned studies to ensure consistency of methods, interpretation, and approach with other Hemab-sponsored studies
Lead global clinical trial execution across multiple regions and countries, ensuring coordination of multinational study teams and compliance with regional regulatory requirements
Lead in the development and review of protocols, study budgets, investigator brochures, clinical study reports, and other clinical documents and regulatory filings as needed
Implement study startup activities, including the development of informed consent forms, study training materials, manuals, plans, and study tools for assigned study
Oversee regulatory/ethics submissions
Effectively evaluating qualified study sites, oversee monitoring activities, and support clinical site initiation visits, co-monitoring, and close-out visits as needed
Oversee day to day study conduct
including management of operation questions from CRO and sites, tracking subject recruitment, laboratory samples, and review of monitoring reports
responsible for study close-out activities
Assess study drug requirements and shipment and supply logistics, contributing to pharmacy manual
Manage study timeline and provide study progress reports to management
Maintain tracking for study metrics that are essential to managing the study closely (patient visit information, data entry, monitoring, and data cleaning information, etc.)
Oversee TMF filing and QC activities as needed
Ensure that all tasks that contribute to the conduct of a clinical study are completed according to ICH/GCP and SOPs, as well as on time and within budget
Train and mentor junior team members

Requirements:

Bachelor’s Degree in life sciences or healthcare discipline
At least 5-7 years of clinical trial management experience and at least 2 years of clinical monitoring experience in the biotech/pharmaceutical industry
Proven experience managing Phase 3 clinical trials from initiation through completion
Direct experience conducting global/multinational clinical trials across multiple geographic regions (US, EU, MENA, Asia-Pacific preferred)
Experience in rare disease or orphan drug development, with demonstrated understanding of unique challenges in patient recruitment, regulatory pathways, and engagement with specialized centers
Working knowledge of ICH/GCP regulations and guidelines
Solid understanding of cross-functional areas, including data management/biostatistics, regulatory affairs, and pharmacovigilance
Proven verbal and written communication skills
enjoys interacting with others regularly
Able to prioritize tasks and work independently
Able to travel an average of 20-30%, both domestically and internationally

Additional Information:

Job Posted:
January 15, 2026

Employment Type:

Fulltime

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