Sironax · 5 days ago
Senior Manager / Associate Director, Clinical Data Management
Waltham, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
8+ years expSironax is seeking a Senior Manager / Associate Director of Clinical Data Management to lead and oversee clinical data management activities across their clinical programs. This role involves ensuring the delivery of high-quality clinical trial data while collaborating with various departments and external vendors to support decision-making and regulatory submissions.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Provide operational and strategic leadership for clinical data management activities across Phase I–III (and IV as applicable) studies
Develop, review, and maintain Data Management Plans (DMPs), CRFs/eCRFs, edit checks, and data review strategies
Oversee database build, UAT, data cleaning, medical coding, and database lock activities
Ensure compliance with global regulatory requirements including ICH-GCP, 21 CFR Part 11, and GCDMP
Manage and oversee CROs and data vendors, including scope definition, oversight, performance tracking, and issue resolution
Apply risk-based data management and quality oversight methodologies to proactively identify and mitigate data risks
Serve as the data management representative on cross-functional study teams and governance forums
Support inspection readiness and participate in audits and regulatory interactions as needed
Contribute to the development and continuous improvement of CDM SOPs, standards, and best practices
Mentor and guide junior data management staff and provide functional leadership as the organization grows
Qualification
Required
Bachelor's degree or higher in life sciences, statistics, computer science, or a related field
8–10+ years of clinical data management experience within biotech, pharmaceutical, or CRO environments
Demonstrated experience managing end-to-end CDM activities for multiple clinical trials
Strong working knowledge of EDC systems, eCOA, IRT, and data integrations
Hands-on experience with CDISC standards (CDASH, SDTM) and data readiness for regulatory submissions
Experience managing CROs and external vendors in a sponsor oversight model
Strong communication, leadership, and cross-functional collaboration skills
Preferred
Experience supporting IND, NDA, or BLA submissions
Prior experience in a small or mid-sized biotech environment
Ability to operate both strategically and tactically in a fast-paced development setting
Company
Sironax
Sironax is a clinical-stage biotechnology company that develops novel products and treatments for age-related degenerative diseases.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$301M2022-08-02Series B· $200M
2019-09-01Series A· $101M
2018-06-01Seed
Leadership Team
Nasir Khan
Senior Vice President of Preclinical Development
Recent News
2025-11-07
Sironax USA, Inc.
2025-10-23
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