Requirements
Requires a bachelor's or advanced degree in a relevant field and several years of clinical data management experience in the pharmaceutical, biotechnology, or clinical research industry. Candidates should have experience with database and EDC design, GCP and regulatory requirements, project and vendor management, and strong analytical and problem-solving skills.
Job Description
Location: Richmond Pharmacology HQ
Description
Job Title: Lead Data Manager
Location: London Bridge (4 days on-site)
Term: Permanent, Full-time
Salary: Competitive + Benefits (Private Medical, Private Dental, Life Assurance, Private Pension & many more)
The Lead 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 Lead Data Manager is essential to advancing our clinical research objectives through effective leadership and expertise in managing complex trial data.
Main Duties And 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.
- 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.
- Bachelor's or advanced degree in a relevant field.
- A number of years of management 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
- Experience in managing relationships with data management vendors and third-party service providers.
- Strong analytical and problem-solving skills to address data-related issues.
Education
Skills
About Richmond Pharmacology
At Richmond, we're on a mission to transform healthcare by delivering faster answers and turning hope into tangible solutions. With over two decades of experience, we've perfected the art of precision, discipline, and innovation in clinical research. Our commitment goes beyond our name – it's a promise to drive progress, elevate patient care, and break down barriers that stand between patients and life-changing treatments. From innovative trial protocols to leveraging our London location and extensive patient database, we're dedicated to making a real impact. Join us in embracing this exciting change. As Richmond, we're shaping a healthier, brighter future, one breakthrough at a time. Stay connected and follow us for updates on our journey of innovation, healing, and hope. #Richmond #FasterAnswers Specialist services: * Early phase adaptive studies including First-In-Human * Cardiac Safety/Intensive ECG/Thorough QT studies * Ethnic Bridging studies * Early phase patient studies (therapeutic and non-therapeutic). Full service: * Consultancy and Expert Advice * Protocol Writing & CRF Design * Regulatory and Ethics Committee Applications * Healthy Volunteer/Patient Recruitment for Phase I-IV * Clinical Conduct, Pharmacy services * Safety Laboratory and Bioanalytical services * Data Management & Statistics and Report Writing
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