Manager, Clinical Data Management

Plan, execute, and complete all data acquisition activities and deliverables within assigned scope Ensure quality, compliance, consistency, and efficiency of data acquisition deliverables Maintain functional planning systems in a timely and effective manner Manage issue escalations using appropriate escalation pathways Anticipate, detect, prevent, and manage risks and issues affecting deliverables and activities Lead or contribute to departmental policies, procedures, training, and standards Contribute to functional vendor contracts and oversee delivery against milestones and scope of work Enhance functional, technical, and scientific capabilities within data management Engage in industry forums and working groups to influence the external industry and regulatory environment Support data acquisition aspects of regulatory inspections and internal audits Ensure real-time inspection readiness for data acquisition deliverables Represent Data Management in cross-functional discussions and contribute to strategic decisions Develop working relationships with stakeholders, partners, suppliers, and industry groups Requirements Bachelor's degree (BS, BA) required, preferably in Clinical Data Management, Health, or Computer Sciences Minimum 6 years of experience in the Pharmaceutical, CRO, or Biotech industry or related field In-depth knowledge of data management practices, tools, and processes In-depth knowledge of regulatory guidelines such as ICH-GCP and standards such as HL7 FHIR Advanced project and risk management skills with a track record of successful outcomes Track record collaborating with multifunctional teams in a matrix environment Experience partnering with or managing stakeholders, customers, and vendors Excellent communication, leadership, influencing, and decision-making skills Excellent written and verbal communication skills Less than 10% domestic or international travel may be required Advanced degree preferred Innovative thinking and experience developing and implementing business changes preferred Experience with EHR/EMR, Digital Health technologies, Real-World Data, eDC systems, eDC integration tools, or data capture platforms preferred Core Competencies Demonstrates expertise in data management practices and regulatory compliance, with a strong focus on project and risk management within the Pharmaceutical, CRO, or Biotech industries. Proven ability to lead cross-functional teams and engage with stakeholders to ensure successful data acquisition deliverables. Highest-signal resume keywords Data Management Practices Regulatory Guidelines (ICH-GCP, HL7 FHIR) Project Management Skills Stakeholder Management EHR/EMR and Digital Health Technologies ATS Optimization Keywords Hard Skills Data Acquisition Risk Management Quality Assurance Compliance Management Project Planning Data Analysis Issue Escalation Management Vendor Management Business Process Improvement Regulatory Inspection Readiness Soft Skills Leadership Communication Influencing Decision-Making Collaboration Industry Keywords Pharmaceutical CRO Biotech Clinical Data Management Real-World Data Tools & Technologies EHR Systems EMR Systems Digital Health Technologies EDC Systems Data Capture Platforms EDC Integration Tools #J-18808-Ljbffr