Senior Clinical Data Associate

Novotech

  • India
  • Permanent
  • Full-time
  • 2 months ago
Job Description:About the role:Senior CDA will be responsible for day-to-day data processing operations for data management projects, including CRF (or other study data document) tracking, entry, and filing. Provides administrative and project management support to CDMs for data management projects as required, including creation and maintenance of project files. Support and mentor junior staff members. Conducts all responsible activities according to ICH-GCP and GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.Minimum Qualifications & Experience:Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least two to four years' experience working in a Clinical Data Associate (or equivalent) role in a pharmaceutical industry or related role.Responsibilities:Member of the project team reporting to the Biometrics Project Manager on projects, the Senior Clinical Data Associate is responsible for independently providing accurate data acquisition, data validation, reconciliation and mentoring the junior staff to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.1. Perform comprehensive data management tasks including data review, query management, external data reconciliation.2. Tracking of CRF pages (or other study data documents) received and entered; tracking of data queries received; proactive metric reporting of CRF pages (or other study data documents) received and entered to study team members3. Prepare and validate database specification and edit checks specification procedures4. Accurate and timely filing of CRFs (or other study data documents), DCFs, or other DM related documents (eg. Data Management Plan, Self-Evident Corrections).5. Accurate and timely archiving of study DMF, CRF Files, and Data Query Master File.6. Perform user acceptance testing of Data Entry Screen and consistence checks ofClinical Study Databases as required.7. Mentor junior CDA staff as required.8. Represent Data Management Team on all CDA related matters, both internally and externally e.g. Investigator meetings, audits etc.9. Support CDM with CDM role activities where appropriate.10. Can act as internal DM Lead on studies, reporting to CDM/SCDM on a study level.11. Liaison with external service providers on Data Management projects as appropriate.12. Proactive participation in project meetings as requested by CDM.13. Prepare agenda/minute writing for data management team meetings; be the lead/facilitator on CDA-related topics/discussion including preparing topic presentations, and being CDA subject matter expert.14. Provide general admin and project management support to Data Management Team as required.15. Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities; awareness of other study team role procedures and how they interact/affect CDA role.16. Proactive contribution to company process improvement initiatives as required; identify opportunities for improvements with the DM Team; lead CDA related process improvements.17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.18. Participation in industry fora (conferences, professional associations etc) as a means of professional development as well as promotion of Novotech's image in industry.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.About Us:Novotech is a global full-service clinical Contract Research Organization (CRO).Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.About the Team: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.
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Novotech