Study Data Manager

Job Description

Job Description

Our client is seeking a Study Manager in Data Management that will be responsible for the planning, coordination, and execution of all data management activities for assigned clinical studies. This role ensures the accuracy, integrity, completeness, and regulatory compliance of clinical trial data from study startup through database lock. The Study Data Manager collaborates with cross-functional teams, including Clinical Operations, Biostatistics, Programming, Medical Monitoring, and external vendors, to support the successful delivery of high-quality clinical data.

Duties and Responsibilities:

• Lead data management activities for assigned clinical studies in accordance with study timelines, applicable regulations, and company standard operating procedures (SOPs).
• Develop, review, and maintain study-specific Data Management Plans (DMPs) and other required documentation.
• Design, review, and validate electronic Case Report Forms (eCRFs) and associated database specifications.
• Coordinate the development, testing, and implementation of Electronic Data Capture (EDC) systems.
• Develop and review edit checks, data validation rules, and discrepancy management processes.
• Monitor data quality by reviewing incoming clinical data, identifying discrepancies, and managing data queries to investigative sites and vendors.
• Coordinate the reconciliation of external data sources, including central laboratory, imaging, electronic patient-reported outcomes (ePRO), and other third-party data.
• Perform User Acceptance Testing (UAT) for clinical databases and system enhancements.
• Track study data management metrics and provide regular status updates to project teams.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, and external vendors to ensure data readiness for analysis.
• Lead database lock activities, including data cleaning, reconciliation, documentation review, and final quality control.
• Ensure compliance with ICH-GCP guidelines, FDA regulations, applicable global regulatory requirements, and company SOPs.
• Support regulatory inspections and audits by providing required documentation and responses related to data management activities.
• Contribute to the continuous improvement of data management processes, standards,
• Support inspection readiness and regulatory submissions
• Serve as the primary DM representative on cross functional project teams and best practices.

Qualifications:

• BS degree in science related field; equivalent education and/or relevant professional experience may be considered.
• Minimum of 4 years Pharmaceutical industry data management experience.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
• Working knowledge of Clinical database applications such as EDC and CTMS. Experience or certification in EDC build is a plus.
• Applicable knowledge working with data analysis tools, such as SAS.
• Experience with working on Phase I-IV study trials within the pharmaceutical industry
• Working knowledge of industry standards, such as the ICH guidelines, CDISC data structures, and FDA guidelines
• Excellent organizational skills, time management, and ability to meet established deadlines
• Excellent verbal and written skills, good organizational, interpersonal, and team skills
• Excellent multi-tasking skills
• Ability to work effectively across a matrix organization.
• Ability to work independently and collaboratively and ability to manage, coach and mentor junior level clinical data managers

Physical and Mental Requirements:

• Ability to multitask
• Adapts to change
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communications
• Adapts change, adjust change and grasps information quickly
• Examine and observe details