Director, Clinical Data Management (Remote/On-site)

Everest-Clinical-Research; Bridgewater Township (NJ); On-site; USD 180,000 - 210,000; Full time

Job summary

Everest Clinical Research seeks a Director, Clinical Data Management for our Bridgewater, New Jersey on-site location, or remotely from a home-based office anywhere in the United States under our Work from Home policy.

You will establish and control clinical data operations to deliver complete, valid, and secure databases, while managing budgets, resources, and client projects; ensuring data capture instruments and databases are timely and compliant with 21 CFR Part 11 and ICH guidelines.

Qualifications

• A MSc in Computer Science, Biostatistics or Mathematics, or Life Sciences.
• At least 15 years of Clinical Data Management experience including a minimum of 3 years line management.
• Comprehensive knowledge of systems, programs, and operations to collect, store, QC and QA clinical data to meet international standards including 21 CFR Part 11 and ICH guidelines.
• Proven ability to lead a team and interact with personnel at all levels; strong analytical and problem-solving skills.

Responsibilities

• Establish and control clinical data operations to provide complete, valid, safe, and secure databases meeting regulatory requirements.
• Develop and manage CDM budget and resource plans; achieve divisional objectives within budget; manage client project portfolios and relations.
• Ensure timely availability of data capture instruments and databases; integrate CDM with QA/Compliance, PM, Clinical Operations, Biostatistics, and other functions.
• Lead development and implementation of SOPs for Clinical Data Management and pursue continuous process improvements.

Job description

Everest Clinical Research seeks a Director, Clinical Data Management for our Bridgewater, New Jersey on-site location, or remotely from a home-based office anywhere in the United States under our Work from Home policy.

You will establish and control clinical data operations to deliver complete, valid, and secure databases, while managing budgets, resources, and client projects; ensuring data capture instruments and databases are timely and compliant with 21 CFR Part 11 and ICH guidelines.