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 CTM/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.
- 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
- Assist 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, planning and presenting at investigator meetings in collaboration with the clinical study team
- Conduct training for logistics of the clinical trial, including protocol contents and coordinating trial materials, as needed
- Effectively evaluating qualified study sites, oversee monitoring activities, and support clinical site initiation visits, co-monitoring, and close-out visits as needed
- Oversee study conduct, including management of operations/medical 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
- Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner
- 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
- Bachelor’s Degree in life sciences or healthcare discipline
- At least 5 years of clinical trial management experience and at least 2 years of clinical monitoring experience in the biotech/pharmaceutical industry
- Working knowledge of ICH/GCP regulations and guidelines
- Experience with international clinical trials and managing external service providers, CROs, and CRAs
- Good 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
Hemab is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.