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POSITION

Data Manager II As a Data Manager II, this role holds the primary responsibility of supporting and coordinating the management of clinical trial data throughout the entire clinical trial lifecycle. This includes executing and overseeing operational Clinical Data Management activities for assigned studies, ensuring timelines and deliverables are met in alignment with client expectations. The role contributes significantly to the generation of reliable, high-quality data that supports evidence-based decisions in healthcare and drug development.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Demonstrate strong work ethic, commitment to quality, and support team collaboration.
• Contribute to a positive team environment by promoting open communication and teamwork.
• Act as a key contact for data-related queries and collaborate with internal and external teams to ensure smooth project execution.
• Support junior team members and contribute to knowledge sharing and mentoring within the team.
• Review study protocols and support the design and documentation of electronic Case Report Forms (eCRFs) using company or sponsor standards.
• Manage assigned tasks to meet project timelines and deliverables, ensuring alignment with client expectations.
• Draft Data Management documentation such as Data Management Plans, Data Review Plans, and specifications, ensuring compliance with relevant standards.
• Participate in data reviews and support task coordination to ensure efficient workload distribution.
• Address data issues and escalate unresolved matters appropriately, collaborating with stakeholders to implement resolutions.
• Develop and implement data cleaning listings to ensure final data assets are accurate and fit for purpose.
• Perform data validation activities prior to go-live and throughout the study lifecycle to maintain data quality.
• Monitor project risks and support mitigation strategies to ensure timelines and customer expectations are met.
• Analyze data using tools and software to identify trends, anomalies, or patterns that may impact study outcomes.
• Maintain data quality, completeness, and consistency throughout the clinical trial lifecycle.
• Follow quality control procedures and support resolution of data-related issues in compliance with SOPs and regulatory standards.
• Contribute to Corrective and Preventative Actions (CAPAs) and support Quality Assurance efforts as required.
• May serve as a Subject Matter Expert.
• Maintain data integrity and compliance with relevant regulations (e.g., FDA, GCP, CDISC).
• Assist in training and onboarding of new team members.

ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE

• Knowledge of the clinical trial process flow.
• Competence of Good Clinical Practices (GCP) and ability to apply relevant regulatory guidelines.
• Solid understanding of data management and project management principles and processes.
• Effective communication and collaboration aptitude.
• Good attention to detail.
• Proven data management skills with the ability to manage tasks independently and contribute to project deliverables.
• Proven problem-solving skills, with the ability to identify and address data-related issues.
• Strong administrative skills including planning, organizing, and time management.
• Ability to take initiative and work independently.
• Preferred 3-5 years of experience in the clinical research industry with 2 years of proven expertise in data management.

Pay:

$88,900.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance

Work Location:

Hybrid remote in Somerset, NJ 08873