PE Global is recruiting a Senior Clinical Data Manager for our pharmaceutical client based in London. The role is an initial 12-month contract and the rates for this role are £44.75 PAYE p/h or £60.79 Umbrella p/h. This role is fully remote with occasional travel to head office within the UK.
The role is fully remote within the UK and some travel to the US would be required.
Responsibilities:
* Develop Data Management playbook to encompass new ways of working with key accountabilities defined and known, both internally within function as well as broader study team
* Assess and determine roles and responsibilities within the Data Management Team
* Clean sheet Data Management processes and identify areas for improvement in line with ICH E6 (R3), utilising technology to streamline efficiencies and reduce hand offs.
* Collaborate with cross-functional teams (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery.
* Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally – consider the role of both Data Management and Site Management, Statistics and Analytics to layer to the model which will deliver studies with an appropriate risk-based approach, e.g.. reduced SDV etc
* Develop and document standard operating procedures (SOPs) for data management activities
* Collaborate with clinical teams to ensure data collection aligns with study objectives.
* Serve as a liaison between data management and other departments, facilitating effective communication with clear leadership and accountability.
* Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-GCP).
* Evaluate new data management tools and technologies (e.g., EDC systems, data integration platforms, data flow).
* Participate in system design, and user acceptance testing.
* Role model with staff on new technologies and ensure smooth integration into new and/or modified processes
* Analyse existing workflows and identify bottlenecks with new ways of working
* Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc.
* Determine key performance indicators (KPIs) and suggest data-driven improvements
* Delivering a quality, fit for purpose dataset – plan, build, review with the end in mind (protocol – data collection – data review – analysis – archive)
Requirements:
* Minimum of 10 years of experience in clinical data management or related field.
* Proven track record of leading delivering on complex process improvement initiatives
* Ideally proven track record of delivering on complex technology implementations.
* Familiarity with Electronic Data Capture (EDC) systems (e.g., Veeva, Medidata).
* Knowledge of data visualization tools (e.g., Tableau, Power BI).
* Knowledge in statistical software (e.g., SAS, R) for data analysis.
* Knowledge, and ideally experience, of working with risk-based approaches (e.g. delivering studies using reduced SDV etc)
Please note PE Global cannot assist with visa sponsorship. Candidates will need to have the full right to work within the UK for at least the next 12 months.