Associate Director, Clinical Data Management
Join Hemab, a clinical-stage biotech company, on an exciting journey to build the ultimate clotting company. We focus on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Cambridge, MA, USA, and Copenhagen, Denmark, Hemab cultivates a vibrant, agile, and forward-thinking environment where collaboration, innovation, and high-quality biotherapeutics development go hand in hand.
As Associate Director, Clinical Data Management, you will be responsible for overseeing data management activities for clinical trials, ensuring high-quality, compliant, and timely data delivery. This role involves strategic planning, operational oversight, vendor management, and cross-functional collaboration to support clinical development programs. The Associate Director will work closely with internal stakeholders, including Clinical Operations, Biostatistics, and Regulatory Affairs.
At Hemab, we foster an environment where everyone can wear ‘multiple hats’ depending on their experience and motivation to get things done ‘right first time’. We constantly strive to celebrate our achievements collectively and gather feedback to sustain and improve our fast-paced cross-functional work environment continuously.
What you’ll Do at Hemab
- Provide leadership for clinical data management activities across multiple clinical studies.
- Drive data management process improvements and innovation.
- Ensure timely database build, data cleaning, and database lock in alignment with study timelines.
- Develop and maintain data management plans and quality control processes.
- Review and approve CRFs, edit check specifications, and data validation plans.
- Oversee and manage external vendors, including CROs and EDC system providers, ensuring adherence to contractual obligations and quality standards.
- Ensure compliance with regulatory guidelines (e.g., FDA, EMA, ICH-GCP, CDISC, GDPR) and company policies.
- Support audit and inspection readiness efforts related to data management.
- Partner with Biostatistics, Programming, and Clinical teams to ensure high-quality data for statistical analysis and regulatory submissions.
- Represent CDM in clinical study team meetings and regulatory discussions.
Who You Are and What You’ll Bring to Hemab
- Bachelor’s or master’s degree in Life Sciences, or related field.
- 10+ years of experience in Clinical Data Management, with at least 3+ years in a leadership or management role.
- Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle, InForm).
- Strong knowledge of industry data standards (CDISC, SDTM), regulatory guidelines, and best practices.
- Proven experience managing CROs, vendors, and internal data management teams.
- Excellent communication, problem-solving, and leadership skills.
- Ability to work in a fast-paced, matrixed environment and manage multiple priorities.
Preferred Qualifications:
- Experience in rare diseases, or other specialized therapeutic areas.
- Familiarity with advanced data technologies, including AI/ML in data management.
- Experience supporting regulatory submissions (NDA/BLA).
- Familiarity and understanding of electronic Patient-Reported Outcomes (ePRO) and eCOA.
