Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

The Role:

We are seeking a detailed orientated, collaborative and process driven Data Quality Manager to form part of our leading edge Real World Data team. The RWD Quality Manager is responsible for ensuring the quality, accuracy, and integrity of data collected and managed by the RWD team. This role involves establishing a data quality framework and conducting rigorous data reviews, identifying discrepancies, and collaborating with cross-functional teams to ensure compliance with data management standards and regulatory requirements.

Key Responsibilities:

Teamwork and Leadership

• Provide strategic leadership and expert support for the program.
• Responsible for resolving data-related issues with the extended RWD team.
• Responsible for overseeing and leading discussions with the risk governance and audit teams.
• Provide advice on issues of governance and quality.
• Collaborate with the RWD Analytics team to ensure adherence to data quality control plans and project timelines.

Communication

• Responsible for the management of quality monitoring and risk reports, highlighting key areas of concern to wider team/business.
• Actively participate in internal, external, and client meetings or audits for data acquisition process and documentation.
• Responsible for training wider RWD Team on quality processes as part of team Learning & Development (L&D).
• Communicates/escalates quality/compliance issues (incl. any potential trends) to necessary stakeholders.

Analytics and Technical

• Responsible for developing and maintaining a data governance framework that focuses on risk management, data quality and continuous improvement.
• Accountable for the design and delivery of quality data systems used for reporting and managing RWD collection and for ensuring that these systems are fit for purpose.
• Provide expert advice on data entry, data validation checks, and edit checks to ensure data accuracy and completeness.
• Responsible for making a significant contribution to the cascading of patient safety data across with business.
• Responsible for the preparation of data quality reports and summaries for internal and external stakeholders.

Data Management

• Act as Subject Matter Expert (SME) for data privacy and security to ensure compliance with data privacy regulations is adhered to in the RWD team.
• Identify process gaps / opportunities for process improvement.
• Develop and map database architecture of data systems.
• Overall responsibility for developing and implementing data quality control activities, guidelines, and best practices.
• Perform comprehensive quality control checks on program data to identify errors, inconsistencies, and discrepancies.
• Accountable for the development and delivery and improvement of data quality assurance strategies.
• Verify compliance with data privacy and security regulations and company standards.

Organisational

• Proactively identify, track and resolve data related issues.
• Monitor industry trends and updates related to data quality control and regulatory requirements.

Requirements

• Has an understanding of data in the context of business benefits and risks.
• Experience of developing and implementing a successful data governance framework.
• Bachelor's or advanced degree in data science, life sciences, health sciences, or a related field.
• Previous experience in clinical research, data management, or quality control is advantageous.
• Strong attention to detail and meticulous approach to data review.
• Experience in RWD/RWE studies/observational/non-interventional studies, including data collection methods, protocols, and case report forms.
• Experience with Jira is preferred.
• Familiarity with electronic data capture (EDC) systems and data management tools is essential.
• Proficiency in using data management tools and software.
• Excellent communication skills for effective collaboration and reporting of data quality findings.
• Experience of delivering effective training and development to teams of all backgrounds.
• Strong problem-solving skills and the ability to identify and address data discrepancies.
• Ability to work independently and manage multiple tasks simultaneously.
• A proactive and organized approach to work, with a commitment to meeting deadlines.
• Knowledge of data privacy and security regulations is advantageous.
• Excellent interpersonal & communication skills.
• Ability to interrogate and analyse complex data.

Benefits

• 27 days holiday plus 8 bank holidays
• Discretionary Bonus Scheme
• Pension contributions 4.5% matched
• Life assurance 4 x annual salary
• Flexible Benefits Platform with £25/month Company contribution
• Annual salary review
• Independent financial advice service
• Enhanced Employee Assistance Programme
• Shopping discounts with retailers
• Long service awards
• Recognition scheme & employee of the year awards

Interested? Please apply today for consideration.