Data Manager

About the role

Critical Needs. Immediate Action. 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.

Responsibilities

• 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 and standardization of Data Management processes, procedures, and best practices across the organization.
• Maintain current knowledge of industry standards, CDASH requirements, ICH-GCP principles, and applicable regulatory expectations relevant to clinical data management.
• Ensure all interactions and engagements are conducted with the highest ethical and professional standards and that all work is performed in accordance with company values.
• Carry out other reasonable duties as required by the Line Manager to support Clinical Development activities.

Education

University degree in a health-related, scientific, technical, or life sciences discipline.

Experience

• 3-5 years of experience in Clinical Data Management within a pharmaceutical company, biotechnology company, CRO, or research-related organization.
• Experience managing clinical studies from study startup/setup through database lock.
• Experience working with Electronic Data Capture (EDC) systems.
• Experience managing outsourced vendors and CRO partners.
• Experience supporting clinical trials within GCP-regulated environments.
• Global clinical trial experience is preferred.
• Experience with CDASH standards and industry best practices for clinical data collection is preferred.

Skills

• Ability to work independently with minimal supervision while effectively collaborating within cross-functional teams.
• Demonstrated ability to exercise sound judgment, prioritize competing activities, and proactively drive deliverables to completion.
• Strong knowledge of the clinical research process from study startup through regulatory submission.
• Knowledge of CDASH standards and clinical data collection best practices.
• Strong knowledge of current ICH-GCP principles and applicable