Director of Clinical Data Management
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Job Location:
Watertown, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system. Noemas research and development is focused on understanding and meeting patient needs using our novel therapies.
Tasks
The Head of Clinical Data Management (CDM) is afunctional leader within Noema Pharma a fastgrowing biotech organization responsible for establishing and driving the companys data management strategy infrastructure and execution across all current and future clinical programs. This role is both strategic and handson ideal for a leader who thrives in a dynamic resourcelean biotech environment where flexibility crossfunctional partnership and operational excellence are essential.
Strategic Leadership
- Develop and execute the CDM strategy aligned with Noemas clinical development portfolio and corporate objectives.
- Establish and maintain CDM governance standards and SOPs to ensure compliance with ICH E6(R3)/ICH E8(R1) 21 CFR Part 11 GDPR (EU) HIPAA (US) and other applicable regulations.
- Drive innovation in data collection technology and analytics (e.g. EDC eCOA/ePRO eConsent data visualization wearables eSource RWE decentralized clinical trials riskbased quality management automation AI-enabled data review).
Operational Leadership
- Oversee data management activities for all clinical studies including database design data validation data cleaning coding data review and database lock.
- Ensure ontime high-quality data delivery to support interim ad hoc and/or final analyses regulatory submissions and data monitoring committee (DMC) reviews.
- Develop and refine metrics KPIs quality frameworks and riskmitigation strategies to optimize CDM execution.
- Manage the development and maintenance of CRFs/eCRFs edit checks and data capture tools.
People & Team Leadership
- Recruit lead and mentor a high-performing global CDM team.
- Develop talent through coaching training workload planning and performance management.
- Cultivate a culture of quality collaboration accountability and continuous improvement.
Vendor & Partnership Management
- Select negotiate with and oversee CROs EDC providers eCOA/ePRO vendors labs imaging vendors and other suppliers that generate clinical data.
- Ensure quality timeliness and budget compliance across outsourced activities.
- Act as the primary point of escalation for CDM issues with external partners.
CrossFunctional Collaboration
- Partner closely with Biostatistics Clinical Operations Clinical Science/Medical Monitoring Safety (PV) Regulatory and Quality to ensure seamless integration of clinical data.
- Support regulatory interactions submissions and filings (INDs NDAs MAAs) audit readiness inspection preparation and responses to health authority queries.
- Contribute to program strategy study design protocol and clinical study report development from a clinical data perspective.
- Represent CDM in internal and external governance committees program/study teams and portfolio planning meetings.
Requirements
- Bachelors or Masters degree in Life Sciences Data Science Biostatistics Public Health Computer Science or related field.
- 10 years of progressive experience in clinical data management within the pharmaceutical biotech or CRO industry with 5 years of leadership experience managing global CDM teams in early and/or latephase clinical studies.
- Demonstrated success with regulatory submissions (NDA/BLA/MAA) strongly preferred.
- Experience with industry leading EDC systems (e.g. Medidata Rave Veeva EDC); expertise in RTSM and eCOA/ePRO data integrations that drive efficiency and productivity is highly preferred
- Demonstrated success managing outsourced data management models.
- Deep understanding of GCP ICH guidelines CDISC standards (CDASH SDTM) and relevant EU and US privacy regulations.
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Excellent communication skills and ability to influence across organizational functions and levels
- Strategic mindset with a hands-on approach when necessary
- Demonstrated experience in evaluating and implementing contemporary data review visualization system capabilities and emerging digital health technologies.
- Experience implementing data management best practices industry data management standards and developing an organizations data management function.
- Ability to operate strategically and execute on operational tasks.
- Strong vendor management and budget oversight skills.
- Ability to thrive in a highly dynamic entrepreneurial biotech culture.
- Willingness to travel globally (1020%).
- Strong commitment to quality patient safety data integrity and scientific excellence.
If you are local or able to travel to the Boston office at least monthly and if your profile matches the above description we look forward to your application.
Key Skills
- Crisis Management
- Marketing
- Public Relations
- Fundraising
- Media Relations
- Constant Contact
- Strategic Planning
- Social Media Management
- Team Management
- Public Speaking
- Wordpress
- Writing Skills
About Company
Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system. Noema’s research and development is focused on understanding and meeting patient needs using our novel therapies.
