Clinical Data Manager

Proclinical Consulting; Boston (KY); Remote; USD 90,000 - 120,000; Full time

Job summary

Proclinical Consulting is seeking a Clinical Data Manager to join our Clinical Data Management team supporting rare disease and pharmaceutical studies. You will ensure data accuracy, compliance, and readiness for analysis while collaborating with CROs and cross-functional study teams.

The role emphasizes data management processes, database validation, and regulatory adherence, with remote US work and a focus on high-quality data standards to impact patient outcomes.

Qualifications

• Bachelor's degree in mathematics, science or related field.
• Experience in clinical data management within biotechnology or pharmaceuticals.
• Ability to coordinate CRO data managers and project teams per SOPs.
• Solid understanding of data management processes, database validation and regulatory compliance.
• Strong collaboration, organizational and communication skills.
• Preferred experience in genetics, oncology or ophthalmology.

Responsibilities

• Act as the primary data management contact for assigned studies with CRO partners.
• Lead CDM activities in line with company SOPs and regulatory requirements.
• Oversee CRO data clean-up from start-up to archiving to ensure quality.
• Manage medical coding, data validation checks, and database snapshots.
• Create and maintain study documents including DM Manual and CRF guidelines.
• Design and modify CRFs and oversee build, test and validation of databases.
• Prepare and distribute project status reports to teams and management.
• Lead the data management team to ensure validated databases for transfer and analysis.

Skills

CRO Coordination

Data Management

Regulatory Compliance

Data Validation

Communication Skills

Education

Bachelor's degree in Mathematics or Science

Job description

Contract - Remote, US

Looking for an opportunity where your clinical data management expertise can directly support groundbreaking pharmaceutical research?

Proclinical is seeking a Clinical Data Manager to join our Clinical Data Management team supporting clinical studies in the rare disease and pharmaceutical space.

Primary Responsibilities

The successful candidate will play a key part in ensuring clinical data is accurate, compliant, and ready for analysis. You will collaborate with vendor project managers, clinical data managers, CROs, and cross-functional study teams to maintain high-quality data standards. This is an exciting opportunity to contribute to impactful projects that make a meaningful difference to patients worldwide.

Skills & Requirements

• Bachelor's degree in mathematics, science, or a related field.
• Experience in clinical data management within biotechnology, pharmaceuticals, or a health-related industry.
• Strong ability to coordinate and manage CRO data managers and project teams, ensuring adherence to policies and procedures.
• Solid understanding of data management processes, database validation, and regulatory compliance.
• Excellent collaboration, organizational, and communication skills.
• Preferred experience in genetics, oncology, and/or ophthalmology.

The Clinical Data Manager's Responsibilities Will Be

• Act as the primary data management contact for assigned studies, representing the function on project teams and partnering with CROs.
• Coordinate and lead clinical data management activities in alignment with company SOPs, policies, and regulatory requirements.
• Oversee CRO data clean-up from study start-up through data archiving to ensure data quality and integrity.
• Manage medical coding, data validation checks, database snapshots, and provide data for analysis.
• Create and maintain study documentation, including the Data Management Manual, CRF completion guidelines, and validation specifications.
• Design and modify CRFs, and oversee the build, testing, and validation of clinical databases.
• Prepare and distribute project status reports to project teams and management.
• Lead the data management team in ensuring databases are validated and ready for transfer and analysis, while supporting standardization of outsourcing partner processes.