Study Manager in Data Management (Remote Contractor) -SkLP

The Study Data Manager is responsible for the planning, coordination, and execution of clinical data management activities for assigned Phase I-IV clinical studies. This position ensures the accuracy, integrity, completeness, and regulatory compliance of clinical trial data from study startup through database lock.

The Study Data Manager serves as the primary Data Management representative on cross-functional study teams and works closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Medical Writing, and external vendors to ensure the timely delivery of high-quality, analysis-ready clinical data., * Lead end-to-end data management activities for assigned clinical studies in accordance with study timelines, regulatory requirements, and company SOPs.

• Develop, review, maintain, and execute study-specific Data Management Plans and related data management documentation.
• Design, review, and validate electronic Case Report Forms (eCRFs), database specifications, and data collection requirements.
• Coordinate the development, testing, validation, and implementation of Electronic Data Capture (EDC) systems.
• Develop and review edit checks, data validation rules, data cleaning strategies, and discrepancy management processes.
• Monitor incoming clinical data for quality, completeness, and consistency; identify discrepancies and oversee the timely resolution of data queries.
• Coordinate reconciliation of external and third-party data, including central laboratory, imaging, ePRO/eCOA, and other vendor data sources.
• Perform and coordinate User Acceptance Testing (UAT) for clinical databases, study builds, and system enhancements.
• Track study data management timelines, risks, deliverables, and quality metrics, and provide regular status updates to project teams and stakeholders.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, Medical Monitoring, and external vendors to ensure data readiness for interim analyses, final analyses, and regulatory submissions.
• Lead database lock activities, including final data cleaning, vendor reconciliation, query resolution, documentation review, and quality control.
• Support inspection readiness, regulatory submissions, internal audits, and regulatory inspections by providing required documentation and responses related to data management activities.
• Ensure compliance with ICH-GCP, FDA regulations and guidance, applicable global regulatory requirements, CDISC standards, and company SOPs.
• Serve as the primary Data Management representative on cross-functional study and project teams.
• Contribute to the continuous improvement of data management processes, standards, tools, and best practices.
• Provide guidance, coaching, and mentorship to junior-level Clinical Data Management team members, as needed., No formal direct reports. The Study Data Manager may provide functional guidance, coaching, and mentorship to junior-level Clinical Data Management team members and may coordinate the work of external vendors and study partners.

• Bachelor’s degree in a scientific, healthcare, life sciences, or related field preferred.
• Equivalent education and relevant professional experience may be considered.

Experience and Technical Qualifications

• Minimum of 4 years of clinical data management experience within the pharmaceutical, biotechnology, or related clinical research industry.
• Experience supporting Phase I-IV clinical trials.
• Strong understanding of the clinical trial process and clinical data management lifecycle from study startup through database lock.
• Working knowledge of Good Clinical Practice (GCP), clinical research regulations, FDA requirements, ICH guidelines, and applicable global regulatory standards.
• Hands-on experience with clinical database and Electronic Data Capture (EDC) systems.
• Experience with EDC database build, configuration, or certification is a plus.
• Experience with external data reconciliation and third-party clinical data vendors.
• Working knowledge of CDISC data standards and structures.
• Familiarity with clinical data review or data analysis tools, including SAS or similar tools.
• Experience supporting inspection readiness, audits, and/or regulatory submissions preferred.

Skills and Competencies

• Strong organizational and time-management skills with the ability to manage multiple studies, priorities, and deadlines.
• Excellent attention to detail and commitment to clinical data quality and integrity.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Strong interpersonal and cross-functional collaboration skills.
• Ability to work effectively within a matrix organization and coordinate activities across internal teams and external vendors.
• Ability to work independently while contributing effectively within collaborative study teams.
• Ability to adapt quickly to changing priorities, study needs, and timelines.
• Ability to remain composed and effective in a deadline-driven environment.
• Ability to understand complex information quickly, follow written and verbal instructions, and communicate issues and solutions clearly.
• Ability to coach and mentor junior-level Clinical Data Management professionals.

Supervision Exercised

Pay: $65.00 - $70.00 per hour