Senior Data Manager

at  Richmond Pharmacology

QUALIFICATIONS AND EXPERIENCE:

• At least 4 years of Proven experience in clinical data management within the pharmaceutical, biotechnology or clinical research industry
• Proficiency in contributing to the design and development of databases, including electronic data capture (EDC) systems, to facilitate accurate and efficient data collection.
• In-depth understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and other relevant regulatory requirements in the clinical trial environment.
• Proven experience in project management, including driving timelines, milestones, and deliverables while ensuring adherence to project timelines and quality standards

PURPOSE OF THE JOB

The Senior Data Manager role is pivotal in providing leadership and strategic direction to our clinical data management team, overseeing the data activities across multiple trials. Responsibilities include contributing to the development of the database design by driving quality assurance through robust data validation checks, and efficient mitigating risks plans of the data quality and compliance. The Senior Data Manager is essential to advancing our clinical research objectives through effective leadership and expertise in managing complex trial data.

KEY RESPONSIBILITIES:

• Provide strategic leadership to the clinical data management team to ensure alignment with the organizational objectives and goals.
• Oversee the planning, execution, and monitoring of data management activities across multiple clinical trials.
• Lead the development and implementation of comprehensive data management plans.
• Drive milestones and deliverables to ensure adherence to the project timelines and quality standards.
• Play a key role in the design and development of databases, including electronic data capture (EDC) systems, to facilitate accurate and efficient data collection.
• Collaborate with vendors to ensure the seamless integration and functionality of data capture tools.
• Establish and implement robust data validation checks and edit checks to ensure a high quality and consistency of clinical trial data.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and industry standards.
• Maintain comprehensive and accurate documentation of the data management activities, including data management plan, data validation, query resolution, and database lock procedures.

ADDITIONAL RESPONSIBILITIES

• Provide training and mentorship to junior data management staff, ensuring their proficiency in data management processes.
• Contribute to the development and implementation of data management procedures, ensuring a high level of expertise within the team.