Head of Clinical Data Management

Noema Pharma•Watertown, SD

21h

About The Position

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. Tasks The Head of Clinical Data Management (CDM) is afunctional leader within Noema Pharma, a fast‑growing biotech organization, responsible for establishing and driving the company’s data management strategy, infrastructure, and execution across all current and future clinical programs. This role is both strategic and hands‑on, ideal for a leader who thrives in a dynamic, resource‑lean biotech environment where flexibility, cross‑functional partnership, and operational excellence are essential. Strategic Leadership Develop and execute the CDM strategy aligned with Noema’s 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, risk‑based 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 on‑time, 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 risk‑mitigation 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. Cross‑Functional 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

Bachelor’s or Master’s 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 late‑phase 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 organization’s 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 (10–20%).
Strong commitment to quality, patient safety, data integrity and scientific excellence.

Responsibilities

Develop and execute the CDM strategy aligned with Noema’s 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, risk‑based quality management, automation, AI-enabled data review).
Oversee data management activities for all clinical studies, including database design, data validation, data cleaning, coding, data review, and database lock.
Ensure on‑time, 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 risk‑mitigation strategies to optimize CDM execution.
Manage the development and maintenance of CRFs/eCRFs, edit checks, and data capture tools.
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.
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.
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.