Data Manager

SERB • Conshohocken, PA

22h • Hybrid

About The Position

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.

Requirements

• University degree in a health-related, scientific, technical, or life sciences discipline.
• 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.
• 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 global regulatory guidelines governing clinical research and Data Management.
• Experience with EDC systems, including database design oversight, User Acceptance Testing (UAT), data cleaning, reconciliation activities, and database lock procedures.
• Experience with eCRF design, edit check specifications, query management, and external data reconciliation.
• Experience authoring, reviewing, maintaining, and implementing Biometrics and Data Management SOPs and procedural documentation.
• Strong vendor and CRO oversight skills.
• Excellent written and verbal communication skills.
• Strong organizational skills and ability to manage multiple priorities across concurrent studies.
• Ability to identify risks, recommend practical solutions, and contribute to continuous process improvement initiatives.
• Positive attitude and ability to interact effectively with stakeholders at all levels of the organization.

Nice To Haves

• Global clinical trial experience is preferred.
• Experience with CDASH standards and industry best practices for clinical data collection is preferred.

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.

Benefits

• Hybrid Working
• Vacation, Personal and Sick time
• 15 Paid Company Holidays
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k), $1 for $1 up to 6% of pay. The safe harbour match is vested immediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager