Data Manager

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SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure.

We operate end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, emergency care, and medical countermeasures reach patients and clinicians with urgency – wherever and whenever they are needed. Shaped over the past 25 years by an entrepreneurial, disruptive spirit, SERB combines the focus and agility of a biotech with the scale, reach, and reliability of a global pharmaceutical company — always grounded in medical purpose, not corporate convention.

Our 600+ employees are driven by three core values:

• Patients first, always
  Patients are not a concept — they are why we act, especially when time matters most.
• Impact focused
  We are agile, entrepreneurial, and disciplined - working smart and learning continuously to deliver results that matter, with the consistency, quality, and trust that critical care demands.
• Team powered
  We go the extra mile - together - because our shared commitment drives extraordinary outcomes.

Guided by a clear ambition and a relentless focus on patients, SERB continues to expand through selective, innovative acquisitions, launching new treatments and entering new geographies. Across every step — from integration to delivery — our people act with passion, ownership, and determination to ensure life-saving medicines become available to patients who need them, worldwide.

The Manager, Data Management is accountable for the overall data management activities of clinical studies, including protocol review and development support, Data Management Plans, eCRF design, database development oversight, data review and cleaning, review of Statistical Analysis Plans (SAPs), database lock activities, vendor oversight, and the development and maintenance of Biometrics and Data Management procedures in compliance with current ICH-GCP principles, applicable regulatory guidelines, and company standards.

The role supports project planning, budget management, resource planning, and Contract Research Organization (CRO) oversight within the context of approved clinical development plans and corporate objectives.

As a Regulatory Clinical Trials Lead, your responsibilities will include :

• Manage Data Management aspects of company-sponsored and investigator-initiated studies (IISs) according to applicable company Standard Operating Procedures (SOPs) and ensure all managed processes are compliant with internal procedures and external regulations.
• Ensure assigned clinical research projects comply with the clinical protocol, current Good Clinical Practice (GCP) principles, and applicable regulatory requirements.
• Lead eCRF design and User Acceptance Testing (UAT) activities and oversee clinical database development and maintenance through database lock.
• Manage clinical data review, query management, reconciliation activities, and database lock processes to ensure data quality and integrity.
• Review study-related Statistical Analysis Plans (SAPs) to ensure alignment with protocol objectives, data collection strategy, and database design.
• Supervise outsourced Data Management activities and manage vendor and CRO relationships.
• Prepare Data Management budgets and manage activities within approved budget parameters.
• Work with Legal, Procurement, and study teams on Data Management-related contracting and vendor activities.
• Author, review, maintain, and implement Biometrics and Data Management SOPs, work instructions, templates, and related procedural documents.
• Collaborate with the broader global Data Management function to support alignment…