Manager, Clinical Data Management

Jobtailor; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking an experienced Data Management professional in the United States (New Jersey) to plan, execute, and deliver data acquisition activities within a regulated pharma environment.

The role requires 6+ years in pharma/CRO/biotech, expertise in ICH-GCP, HL7 FHIR, and strong leadership, communication, and risk management skills; occasional travel up to 10% may be needed. Advanced degree preferred.

Qualifications

• Bachelor's degree required in Clinical Data Management, Health, or Computer Sciences.
• Minimum 6 years of experience in Pharmaceutical, CRO, Biotech or related field.
• In-depth knowledge of data management practices, tools, and processes.
• Knowledge of regulatory guidelines such as ICH-GCP and HL7 FHIR.
• Advanced project and risk management skills with track record of successful outcomes.
• Experience 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.
• Less than 10% 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.

Responsibilities

• 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

Skills

Data Acquisition

Risk Management

Quality Assurance

Compliance Management

Project Planning

Data Analysis

Issue Escalation

Vendor Management

Business Process Improvement

Regulatory Inspection Readiness

Leadership

Communication

Influencing

Decision-Making

Collaboration

Education

Bachelor's degree (BS, BA) in Clinical Data Management / Health / Computer Sciences

Advanced degree preferred

Tools

EHR Systems

EMR Systems

Digital Health Technologies

EDC Systems

Data Capture Platforms

EDC Integration Tools

Job description

• 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