Novotech
Website:
novotech-cro.com
Job details:
The Clinical Analytics Specialist / Senior Specialist supports the Clinical Systems & Technology function by delivering analytics and reporting capabilities that underpin the four pillars of the function: Clinical Reporting, Veeva, Obvio, and AI Tools & Automation. The role is primarily focused on reporting, adoption, and compliance, developing clinical data reports and dashboards, supporting the adoption of clinical systems and platforms across the organisation, and ensuring ongoing compliance with SOPs, data governance, and regulatory standards. The Specialist provides analytical and operational support across clinical platforms, liaises with varied internal stakeholders, and ensures the ongoing maintenance and quality of clinical systems data across all projects. The Senior Specialist performs these responsibilities with greater autonomy, takes a lead role in driving adoption and process improvement, and may support or mentor Specialist team members.
Minimum Qualifications & Experience:
- Specialist: Minimum of 2 years' experience in a clinical role within a CRO, Pharmaceutical company, or in healthcare analytics, clinical data analysis, or a related field.
- Senior Specialist: Minimum of 4-5 years' experience in a clinical analytics, clinical systems, or related role within a CRO, Pharmaceutical company, or healthcare analytics environment, with a demonstrated track record of leading reporting initiatives, driving system adoption, and operating with greater autonomy across clinical systems and stakeholder groups.
- Minimum of 1-2 years' experience in data entry.
- Strong skills with Veeva Clinical, Clue Points, Spotfire, SalesForce would be highly regarded.
- Experience with data visualization tools (e.g., Tableau, Power BI) and reporting techniques to effectively communicate insights to stakeholders.
- Exposure to Advanced Microsoft Excel, e.g. creating pivot tables, Macros/VBA, Power Query, Report Automation, Power BI, and ETL tools.
- Work with data engineers, analytics lead and data scientists to develop data pipelines, analytical models, and visualisations that meet business requirements.
- Collaborate with business stakeholders to understand their data and analytics needs and contribute to development of a product roadmap that aligns with business goals.
- Consistent track record of delivering high performance and effectively communicating across all organizational levels, underscoring excellent written and verbal communication skills.
- Monitor data and analytics product performance and identify opportunities for improvement.
- Act as a subject matter expert for data and analytics products and provide guidance to business stakeholders on how to effectively use these products.
- High attention to detail and accuracy is essential.
- Strong analytical and problem-solving skills is essential.
- Demonstrated ability to operate autonomously as well as collaborate seamlessly within cross-functional teams to achieve shared objectives.
Responsibilities
- Develop Veeva reporting and BI analytics solutions under appropriate supervision to ensure the timely delivery of clinical data reports and visualizations as outlined in standard, study-specific, or company-specific data review plans.
- Own and manage all Veeva reports and dashboard tickets, acting as the primary point of accountability for triaging, prioritising, and resolving requests in accordance with agreed service level agreements (SLAs); proactively monitor ticket queues to ensure timely delivery and escalate risks to SLA compliance as appropriate.
- Provide technical support to cross-functional teams and project management, aiding in reporting and data visualization adoption, through development of comprehensive training materials. Support stakeholders in sourcing the data needed to prepare monthly and ad hoc management reports.
- Demonstrate a comprehensive understanding of the drug development process and data operations necessary for clinical trial data reporting, including data review, study reports, regulatory submissions, safety updates, etc.
- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort.
- Identify project implementation and system execution risks and raise issues appropriately.
- Assist in client data transfer processes, ensuring accurate and secure data transmission.
- Ensure compliance with applicable SOPs and work practices to maintain data integrity and regulatory compliance.
- Support team with the implementation of Data Governance framework, data cleansing, and ensuring data quality meets business needs.
- Support team in periodic assessments, measure KPIs, generate Compliance Reports, perform Gap analysis, and drive Continuous Improvements.
- Provide support for related tasks such as data migration, data validation, User Acceptance Testing (UAT), as needed.
- May be required to support reporting and analytics associated with other platforms, for example other Veeva Vaults, EDC, Simple Trials, Risk-Based Quality Management (RBQM) solutions and CRM Analytics. Analytics support across these platforms should be understood in the context of the four pillars of the Clinical Systems & Technology function (Clinical Reporting, Veeva, Obvio, and AI Tools & Automation), with a primary focus on reporting, adoption, and compliance activities.
Senior Specialist:
- Take a lead role in driving reporting adoption across the organisation, including owning the development and maintenance of standard clinical reporting templates and dashboards aligned to the four pillars of Clinical Systems & Technology. Act as a primary point of contact for adoption queries and escalations from the wider clinical team, and contribute to shaping the compliance monitoring framework for clinical systems.
- Support or mentor Specialist team members and contribute to quality review of reporting outputs. Represent the team in cross-functional meetings as required.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
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