ABOUT HEMAB

Hemab Therapeutics is a clinical stage, international biotechnology company that is pursuing a vision of re-imagining blood clotting therapies at the heart of human resilience. Hemab is pioneering the first targeted, preventative treatments and functional cures for underserved bleeding and thrombotic disorders—reframing the standard of care for patients everywhere. While patients with common bleeding and thrombotic disorders have had access to preventative treatments for more than a half-century, no such measures exist for less-common disorders. For these tens of thousands of men, women, and children, life is paralyzingly unpredictable. It’s time to ensure that every patient with a clotting disorder has the security and peace of mind they deserve.

Our teams are global, diverse, and committed to collaboration, excellent research, and swift development of our potential therapies.

ABOUT YOUR ROLE

As a Director, Clinical Data Management, you will be responsible for leading the clinical data management processes across Hemab’s clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling.

WHAT YOU WILL DO

Manage the clinical data management partnership with clinical CROs for Hemab’s clinical trials
Provide oversight for fully outsourced clinical data management activities from RFP to final database lock by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools
Develop and/or write the database design, edit checks, CRF completion guidelines, and Data Management Plan for in-house data management activities ensuring CDASH and SDTM standards
Work with cross functional team members to standardize data collection and reporting
Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure that project timelines and goals are met effectively, and within budget
Attend study team meetings to provide updates and issue resolution in terms of data collection through analysis
Work collaboratively with cross functional team members to ensure clinical data is ready for early phase deliverables in stream
Support a Hemab eCRF library, data standards, and database build configuration
Additional duties and responsibilities as required

WHAT YOU’LL BRING

Bachelor’s degree in computer science, or a science-based subject with at least 12 years
of clinical data management experience in industry, with experience across indications
and EDC platforms
Strong vendor management and oversight experience
Experience hiring and building a data management team
Solid technical skills across data platforms; programming experience preferred
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
Cross collaboration proficiency with other development-related functions such as
Biostatistics, Statistical Programming, and Pharmacovigilance
Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical
trial data
Experience in regulatory GCP inspections/audits preferred
Experience with Spotfire, eluminate or other data visualization software
Ability to manage multiple projects in a fast-paced environment

Hemab Therapeutics 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.

Hemab Therapeutics jobs

Director, Clinical Data Management