Data Management Lead

argenx•Boston, MA

About The Position

The Data Management Lead (DML), also referred to as the Clinical Data Management Lead (CDML), is accountable for all Data Management aspects of an assigned compound and/or indication from initiation through closure. The role ensures clinical data completeness, accuracy, and consistency meet quality standards for analysis and regulatory reporting, in compliance with local and global regulations. It also includes line management responsibilities for a team of Clinical Data Managers (CDMs). The CDML provides Data Management leadership within clinical and indication teams, collaborating with CROs and internal and external partners to support clinical development strategy throughout a compound’s lifecycle, from first-in-human trials through registration and post-approval development. The role oversees trial deliverables, budgets, timelines, quality, risk mitigation, inspection readiness, and regulatory compliance, and contributes to clinical development plans and protocols. The position also leads or participates in process-improvement initiatives, regulatory inspections, and company audits. It includes onboarding, training, mentoring, and supporting the growth and development of direct reports, in collaboration with the Clinical Data Portfolio Lead.

Requirements

Bachelor’s or master’s degree in a medical or para-medical field (such as Biology, Biomedical Sciences, Pharmacy, or Veterinary Medicine), mathematics, or equivalent experience.
Demonstrated experience in Clinical Data Management and managing CROs and vendors.
Ability to work effectively within a team matrix and independently.
Strong communication and interpersonal skills.
Fluency in written and spoken English.
Ability to motivate and manage team members, prioritize tasks, and organize workload.
Leadership ability and strong people-management skills; able to work independently and as a team player.

Nice To Haves

Biotechnology experience.
Clinical study background in autoimmune and/or orphan diseases.
Line management experience.

Responsibilities

Lead engagement with CROs and internal and external partners to establish and align Data Management expectations for assigned compounds or indications.
Lead Data Management participation in clinical and indication teams responsible for clinical development strategy across a compound’s lifecycle, from first-in-human trials through registration and post-approval development.
Participate in creating and maintaining the Clinical Development Plan, including effective and, where possible, innovative trial designs.
Oversee risk identification and mitigation for the Clinical Development Plan; identify risks or deviations, communicate them to relevant leaders, propose solutions, and oversee implementation.
Set quality expectations and timelines for Data Management deliverables, monitor milestones, and maintain inspection readiness.
Ensure compliance with SOPs, company policies, and regulatory requirements from trial start-up through close-out.
Communicate expectations transparently, set clear direction, and motivate team members to achieve clinical goals in line with company objectives and cultural pillars.
Oversee CRO selection and contract negotiations for assigned compounds or indications.
Support clinical budget oversight; collaborate with CDMs and statisticians to prepare, review, and update budgets, ensure activities remain within budget, and proactively escalate issues to the Program Leader.
Contribute to protocol development or review for Data Management-related sections, including data-collection feasibility, adherence to industry and company standards, and interim locks.
Oversee CRO-outsourced deliverables according to the Statement of Work and Data Management Trial Oversight Plan, including data-collection tools, EDC integrations, essential documents, submission-ready clinical data packages, and clinical data archival packages.
Ensure Data Management essential documents are timely and sufficiently complete to assess trial conduct and data quality.
Track project plans, budgets, metrics, and KPIs; adjust plans in consultation with relevant Data Management and Clinical Team stakeholders.
Ensure consistency across trials for assigned compounds or indications and share learnings and best practices within the indication and department.
Lead or participate in process-improvement initiatives.
Participate in regulatory inspections and company audits.
Line-manage Clinical Data Managers, including onboarding new direct reports.
Ensure assigned staff are adequately trained and that training is documented.
Mentor and support the growth and development of assigned staff.
Collaborate with the Clinical Data Portfolio Lead on goal setting and reviews for the role and direct reports.