VP Data Management
Found in: beBee jobs US - 3 weeks ago
Organizational Overview:
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
The Role:
Reporting to the Senior Vice President of Biometrics, the Vice President of Data Management that will be responsible for looking across the portfolio, being accountable for the Data Management strategy and processes and leading the team. This individual will serve as a key member of the Clinical Development Leadership Team, contributing to the establishment of a high-performing organization. They are expected to possess extensive experience as a functional area project and people leader, with expert knowledge in Data Management strategy, operations, and processes, coupled with exceptional people leadership skills.
Key Responsibilities:
- Oversee across the portfolio, accountable for the Data Management strategy and processes, and lead the team through a period of rapid growth with numerous priorities and accelerated timelines.
- Serve as a key member of the Clinical Development Leadership Team, contributing to the establishment of an effective, well-functioning organization.
- Collaborate with Clinical Operations, Biostatistics and Programming, and other cross-functional teams to ensure seamless integration of data management activities throughout the clinical trial lifecycle.
- Develop and implement the overall clinical data management strategy, policies, and processes in alignment with regulatory requirements, industry best practices, and company goals.
- Manage relationships with external vendors, including CROs and technology providers, to ensure the successful execution of data management activities.
- Ensure compliance with regulatory requirements, including GCP, ICH guidelines, and other applicable regulations.
- Establish and ensure compliance with Data Management SOPs to maintain consistency and quality in data management practices.
Requirements:
- Bachelor's degree in relevant scientific or technical discipline; advanced degree (PhD, MS, etc.) preferred.
- 10+ years of clinical data management experience in biotech and/or pharmaceutical industry, with a minimum of 3 years in a leadership or management role.
- In-depth knowledge of clinical data management principles, practices, and regulatory requirements, including CRF, CDISC standards, GCP, and ICH guidelines.
- Proficiency in data management tools and technologies, such as EDC systems and CTMS.
- Proven experience managing clinical trial databases and overseeing data management activities for Phase I-III clinical trials.
- Entrepreneurial spirit, strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
- Excellent problem-solving and decision-making abilities, with a focus on driving results and delivering high-quality data.
- Experience working in a fast-paced, dynamic environment with tight deadlines and changing priorities.
Work Environment:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
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