Nicholas Howard have are delighted to be recruiting for a Senior Clinical Data Analyst to join our client, an SME specialising in the development of software products and eCOA for the pharmaceutical and healthcare sectors. As the business continues to grow, this is an excellent opportunity to play a key and leading role within study teams across a number of client phase 1 trials, alongside a project manager, on the end to end provision on clinical data. The nature of an SME comes with great exposure to all aspects of the role, client engagement, and working with multiple internal and external teams, providing a great platform for skills development and growth.
The role is responsible for:
Study & Data Management
•Conduct data management services ensuring high quality and completeness of data from collection to final database lock.
•Compile Data Management Plans (DMPs), Data Validation Specification (DVS, with input from the Data Science team), and Data Transfer Specifications (DTS).
•Complete monthly data reconciliations, raising queries to site and sponsor, and generating reports to support this per the DMP, DVS, and DTS.
•Conduct data cleaning activities including data review and validation checks, query and data issue generation and Data Change Request (DCR) management.
•Prepare study datasets for execution of data transfers and/or statistical analysis.
•Conduct database lock activities, including offboarding user access and conducting quality control review of lock documentation.
•Liaise with Project Management and Product Management to archive study documentation and data, and ePRO system data.
In addition:
•Develop clinical study training materials including training guides, system manuals and e-learning presentations utilising the Learning Management System (LMS), liaising with the Product and Science teams as required.
•Conduct site and user onboarding activities including account management.
•Provide helpdesk support for clinical study and/or technical issues using the internal ticketing system (Freshdesk) to monitor study progress and ensure key performance metrics are met.
Communications
•Develop positive and constructive professional relationships with client and study project lead
•Prepare for, lead, and capture output of study, site, and/or data-related Client interactions and meetings
•Maintain close interactions with the Data Science team to ensure optimised study support and knowledge sharing
•Form proactive partnership with third-party vendors hosting in-study calls where required
•Proactively contribute to study delivery process improvements, author and/or review company SOPs and guidelines relevant to Data Management activities
Line Management
•Personnel management and/or mentorship of junior Clinical Data Analysts or Clinical Data Associates, as required
•Evaluate direct reports’ performance and provide feedback
•Pursue training opportunities and/or continuous professional development
Skills and experience
•Graduate with a Life Science, or equivalent degree (IIi or above) and/or a higher degree
•Experience (minimum 2 years) of clinical data management required
•Therapeutic experience in CNS desirable
•Experience of GCP and Clinical Trial regulations specifically related to Data integrity, Data Management and Computer Systems required
•Knowledge of Microsoft Office, Excel skills, Python or Power BI tools an advantage
•Excellent organisational, planning and time management skills
•Strong prioritisation skills and be flexible to adapt plans
•Excellent communications skills - written and verbal
•A concern for quality, attention to detail, and accuracy
•Excellent logical, analytical, and problem-solving skills
•Confidence in decision-making
•Ability to work flexibly and to tight deadlines when required
•Ability to work effectively with others
•Background in mentoring junior staff desirable
Please apply with CV in the first instance for more information
