Job Title: Head of Data Management

Location: London Bridge (4 days onsite/1 day from home)

Term: Permanent, Full-time

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension,25 days Annual leave plus bank holidays& Many more)

Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.

The Role:

We are seeking a dynamic and results-driven Head of Data Management. The Head of Data Management provides strategic leadership for the Data Management department, ensuring the integrity, accuracy, and compliance of clinical trial data while driving innovation and fostering collaboration across teams to achieve organisational goals.

Key Responsibilities:

Strategic Planning:

• Develop and implement strategic plans for data management, aligning with the organisation's clinical development objectives.
• Drive innovation and adoption of best practices in data management processes.
• Monitor budgets for data management functions to ensure cost-efficiency. Review the DM section of the study quotes. Attend bid defence meetings.

Team Leadership:

• Lead and manage a team of data managers, coordinators, and other data-related professionals.
• Foster a collaborative and high-performance culture within the data management team.
• Oversee KPIs, appraisals, and team development to ensure accountability and growth.

Clinical Data Standards and Regulatory Compliance:

• Ensure adherence to regulatory and industry standards for data collection, transformation, and submission, maintaining compliance with Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines.
• Stay updated on evolving regulatory requirements and industry expectations, proactively aligning data management processes to meet current and future compliance standards.

Data Management Processes:

• Develop and optimise end-to-end data management processes, from study startup to database lock: Study startup, DHP, eCRF development and validation checks, Data cleaning, Medical coding, External data reconciliations, Database lock, Data export and archival.

Quality Control:

• Implement and monitor risk based data quality control processes to ensure accuracy, completeness, and consistency of clinical trial data.
• Conduct regular audits to assess data management processes and identify areas for improvement.

Technology Integration:

• Evaluate and implement innovative technologies to enhance data collection, cleaning, and reporting capabilities.
• Collaborate with IT and vendors to integrate and optimise data management systems.

Training and Development:

• Provide training and mentorship to the data management team, ensuring ongoing professional development.
• Foster a culture of continuous learning and knowledge sharing within the team using standardised training methods.

Qualifications and Experience:

Essential:

• At least 10 years of proven experience in clinical data management within the pharmaceutical, biotechnology, or clinical research industry.
• Bachelor's or advanced degree in a relevant field.
• 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.
• Experience in providing mentorship and guidance to junior members of the data management team, contributing to the training and development of staff.
• Leadership skills to guide and manage a team of data management professionals.
• Ability to think strategically and contribute to the development and implementation of data management strategies for clinical trials.
• High ethical standards and integrity in handling sensitive and confidential clinical trial data.

Desirable

• Basic knowledge of programming languages can be beneficial for automation and customisation (preferred but not mandatory).

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.