Senior Clinical Data Management Director (Remote/Hybrid)

Everest Clinical Research; Bridgewater (MA); Sur place; USD 180 000 - 210 000; Plein temps

Résumé du poste

Everest Clinical Research seeks a senior Director of Clinical Data Management for its Bridgewater, NJ on-site location, or remote from a US home-based office. Lead data operations, budget planning, and cross-functional collaboration to ensure compliant data capture and analysis for complex studies.

You will manage a seasoned team, design SOPs, foster client relationships, and drive process improvements while aligning with regulatory standards (21 CFR Part 11, ICH).

Qualifications

• M.Sc. in Computer Science, Biostatistics or Mathematics, or Life Sciences. Lower academic degrees acceptable with proven abilities.
• At least 15 years’ Clinical Data Management experience including a minimum of 3 years line management experience.
• Knowledge of systems to collect, store, QC and QA clinical data to meet 21 CFR Part 11 and ICH guidelines.
• Experience leading a team with strong people management and cross-functional interaction.
• Experience in designing and implementing Standard Operating Procedures for Clinical Data Management.
• Experience with client relationship management and business development is preferred.
• Strong analytical, problem solving, and communication skills; ability to implement new standards and drive process improvements.

Responsabilités

• Establish and control clinical data operations to provide compliant databases meeting regulatory requirements.
• Develop and manage clinical data management budget and resources; achieve divisional objectives within budget.
• Manage client project portfolios and maintain strong client relations; assist in bids for new projects.
• Ensure timely availability of data capture instruments and databases for product development and registration.
• Integrate Data Management with QA, Project Management, Clinical Operations, Biostatistics, and Medical Writing.
• Recruit, train, motivate, and develop staff; conduct performance reviews and training.
• Plan and control resources to fulfill unit and corporate missions and policies.

Connaissances

People management

Client relationships

Analytical thinking

Communication skills

Formation

M.Sc. in Computer Science/Biostatistics/Math/Life Sciences

Description du poste

Everest Clinical Research seeks a senior Director of Clinical Data Management for its Bridgewater, NJ on-site location, or remote from a US home-based office. Lead data operations, budget planning, and cross-functional collaboration to ensure compliant data capture and analysis for complex studies.

You will manage a seasoned team, design SOPs, foster client relationships, and drive process improvements while aligning with regulatory standards (21 CFR Part 11, ICH).