About The Role:
The Senior Clinical Lead Analyst (CLA) works collaboratively with Clinical Lead in managing clinical delivery of the project, by closely monitoring the clinical deliverables, project performance & schedule, compliance, risks, quality of the project.
Minimum Qualifications & Experience:
- Requires minimum of 5 years of work experience, with minimum 3 years of relevant experience in a clinical research organization or equivalent role.
- Basic knowledge of applicable research and regulatory requirements, i.e. International Conference on Harmonization - Good Clinical Practice and relevant local laws, regulations, and guidelines.
- Knowledge of Microsoft Applications including but not limited to Microsoft Excel, Word and PowerPoint.
- Exposure to basic data analysis required for projects during start-up, maintenance and close outs.
- Certification course in Clinical Research will be an added advantage.
Responsibilities:
- SCLA provides analytics, reports, status update, risk alerts and required mitigation recommendations to the Clinical Lead and rest of the clinical team throughout the lifecycle of the project.
- SCLA supports the Clinical Lead with tools to ensure efficient oversight of clinical deliverables of a project and to ensure adherence to project scope (clinical), protocol, SOPs, applicable regulations, and study plans (CMAP, PD management plan, recruitment plan, IQRMP, IP management, etc.) focusing on applications, analytics, therapeutics, regional requirements, blinding processes, project milestones, and quality perspectives.
- Conducts periodic review of project KPIs, shares status/analysis, follows up for open action items in accordance to clinical lead’s directions.
- Monitors site-performance parameters at study level and makes recommendations for timely corrective actions under the guidance of Clinical Lead.
- Evaluates the quality of study processes (clinical) and supports the Clinical in monitoring quality of conduct of the protocol and adherence to applicable regulations.
- Establishes and maintains effective project/site-level communications with relevant stakeholders (for clinical) as delegated by Clinical Lead.
- Ensures compliance on study databases (Clinical Trial Management System (CTMS), Interactive Web Response System (IWRS), Electronic Data Capture (EDC) etc.)
- Supports Clinical Lead in protocol deviation management.
- Performs assigned administrative tasks to support Clinical Lead with project execution.
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 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 contacting you regarding your application.
Responsibilities:
- SCLA provides analytics, reports, status update, risk alerts and required mitigation recommendations to the Clinical Lead and rest of the clinical team throughout the lifecycle of the project.
- SCLA supports the Clinical Lead with tools to ensure efficient oversight of clinical deliverables of a project and to ensure adherence to project scope (clinical), protocol, SOPs, applicable regulations, and study plans (CMAP, PD management plan, recruitment plan, IQRMP, IP management, etc.) focusing on applications, analytics, therapeutics, regional requirements, blinding processes, project milestones, and quality perspectives.
- Conducts periodic review of project KPIs, shares status/analysis, follows up for open action items in accordance to clinical lead’s directions.
- Monitors site-performance parameters at study level and makes recommendations for timely corrective actions under the guidance of Clinical Lead.
- Evaluates the quality of study processes (clinical) and supports the Clinical in monitoring quality of conduct of the protocol and adherence to applicable regulations.
- Establishes and maintains effective project/site-level communications with relevant stakeholders (for clinical) as delegated by Clinical Lead.
- Ensures compliance on study databases (Clinical Trial Management System (CTMS), Interactive Web Response System (IWRS), Electronic Data Capture (EDC) etc.)
- Supports Clinical Lead in protocol deviation management.
- Performs assigned administrative tasks to support Clinical Lead with project execution.
Minimum Qualifications & Experience:
- Requires minimum of 5 years of work experience, with minimum 3 years of relevant experience in a clinical research organization or equivalent role.
- Basic knowledge of applicable research and regulatory requirements, i.e. International Conference on Harmonization - Good Clinical Practice and relevant local laws, regulations, and guidelines.
- Knowledge of Microsoft Applications including but not limited to Microsoft Excel, Word and PowerPoint.
- Exposure to basic data analysis required for projects during start-up, maintenance and close outs.
- Certification course in Clinical Research will be an added advantage.
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
