Data Manager Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide expert technical knowledge across all facets of Data Management and act as the main point of contact for assigned studies.

• Ensure that all contracted Data Management deliverables are achieved with an emphasis on quality and on-time completion.

• Oversee study data delivery timelines, which include Go-Live, Interim Deliveries, and Final Database Lock.

• Collaborate with Clinical, Biostatistics, Database Programming, Medical, Medical Writing, and other cross-functional stakeholders across global regions.

• Manage and coordinate the integration and use of ancillary systems.

• Identify risks and challenges affecting study delivery, establish mitigation strategies, and facilitate issue resolution.

• Review and analyze study metrics to detect trends and summarize study health.

• Review Master Services Agreements, Service Level Agreements, and contracts to oversee sponsor-specific metrics and Key Performance Indicators.

• Attend cross-functional meetings and create agendas, meeting minutes, action logs, and decision logs.

• Exhibit technical and operational expertise in Data Management during bid pursuits and proposals.

• Contribute to bid pursuit presentations and materials.

• Represent Data Management during presentations to sponsors.

• Ensure adherence to Standard Operating Procedures and ICH/GCP guidelines.

• Maintain inspection-ready Trial Master Files.

• Identify and document quality issues, ensuring proper resolution and closure.

• Prepare for and engage in internal, sponsor, and regulatory audits and inspections.

• Drive and implement corrective and preventive actions while sharing lessons learned.

• Collaborate with Delivery Leads and line management regarding project resources and staff assignments.

• Identify and request necessary functional resources for project execution.

• Support the resolution of Data Management-related project variances, including changes in scope.

• Provide Data Management insights for organizational initiatives and feedback on them.

• Ensure that management system information is accurate and up-to-date.

• Maintain compliance with required training, including on-the-job training.

• Deliver project-specific training to internal Data Management teams.

• Support development goals and training requirements.

• Provide on-the-job training when needed.

• The Data Manager II may mentor Assistant Data Managers and Data Management colleagues.

⛳️ Requirements

• Extensive experience in the clinical research industry.

• 6+ years of practical Clinical Data Management experience.

• Demonstrated experience in leading project and program teams.

• Solid understanding of project tools, reports, and processes related to project financial management, including forecasting, revenue recognition, scope of work, and departmental budgets.

• Good grasp of Clinical Study Team roles beyond Data Management.

• Strong knowledge and application of ICH-GCP guidelines, local regulatory requirements, Standard Operating Procedures, and study-specific procedures.

• Awareness of SDTM, CDISC, and CDASH standards.

• High technical proficiency with Clinical Trial/Data Management Systems such as InForm, Rave, Veeva, DataLabs, and Microsoft Office applications.

• Strong ability to lead and collaborate with global teams across various time zones and cultures.

• Excellent negotiation and influencing abilities.

• Outstanding interpersonal, written, and verbal communication skills.

• Strong learning agility and a mindset geared towards knowledge sharing.

• Flexibility and adaptability in dynamic environments.

• Effective presentation skills.

• Strong customer focus, with the capability to build rapport and trust.

• Commitment to quality, exhibiting a methodical and precise approach to work.

• Strong time management and prioritization capabilities.

• Proven problem-solving skills and root cause analysis expertise.

• Strong sense of ownership and accountability.

• Willingness to travel as necessary.

• Proficient in written and spoken English.

• Bachelor's degree and/or other qualifications in a science or clinical-related field.

🏝️ Benefits

• Remote work arrangement.

• On-the-job training.

• Project-specific training.

• Support for identified development goals and training needs.

• Equal opportunity employment.