Job Description

Clinical Data Associate I

Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.

Responsibilities

Member of the project team reporting to the Biometrics Project Manager on projects, the Clinical Data Associate I is responsible for providing accurate data acquisition, data validation and reconciliation to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.

1. Data entry of clinical trial data using Clinical Data Management software.
2. Assistance in review of data queries to be raised with sponsor companies/monitoring staff.
3. Tracking of CRF pages received and entered, tracking of data queries sent received and entered.
4. Assist CDM with database testing and edit checks testing as appropriate.
5. Assist CDM with data cleaning/validation and reconciliation of external data
6. Develop and maintain good communications and working relationships with lead CDMs.
7. Assist CDM to create reports, listings, and other output as required during the course of the project.
8. May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.
9. Assist with the development and update of systems to track study progress as per the CDM requirements (i.e. Novotrak, CRF & query flow, safety reports, etc.). Provide updates on study progress to CDM as required.
10. Participation in project meetings as requested by CDM.
11. Assist with agenda/minute writing for data management teams.
12. Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.
13. Provide general admin support to Data Management according to the needs of the Clinical Data Manager.
14. Active contribution to company process improvement initiatives as assigned.
15. 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.
16. Participation in industry fora (conferences, professional associations, etc) as a means of professional development as well as promotion of Novotech’s image in industry.
17. Any other tasks associated with the day-to-day functioning of the DM Team as per the discretion and delegation of the Line Manager.

Minimum Qualifications & Experience:

• Graduate in a clinical or life sciences related field.
• Relevant experience/qualifications in allied professions may also be considered.
• Preferably at least six months to one year experience working in the research, pharmaceutical industry or a related field.

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

Responsibilities

Member of the project team reporting to the Biometrics Project Manager on projects, the
Clinical Data Associate I is responsible for providing accurate data acquisition, data
validation and reconciliation to the clinical studies and shall ensure quality standards per
SOPs and ICH-GCP.

1. Data entry of clinical trial data using Clinical Data Management software.
2. Assistance in review of data queries to be raised with sponsor companies/monitoring staff.
3. Tracking of CRF pages received and entered, tracking of data queries sent received and entered.
4. Assist CDM with database testing and edit checks testing as appropriate.
5. Assist CDM with data cleaning/validation and reconciliation of external data
6. Develop and maintain good communications and working relationships with lead CDMs.
7. Assist CDM to create reports, listings, and other output as required during the course of the project.
8. May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.
9. Assist with the development and update of systems to track study progress as per the CDM requirements (i.e. Novotrak, CRF & query flow, safety reports, etc.). Provide updates on study progress to CDM as required.
10. Participation in project meetings as requested by CDM.
11. Assist with agenda/minute writing for data management teams.
12. Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.
13. Provide general admin support to Data Management according to the needs of the Clinical Data Manager.
14. Active contribution to company process improvement initiatives as assigned.
15. 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.
16. Participation in industry fora (conferences, professional associations, etc) as a means of professional development as well as promotion of Novotech’s image in industry.
17. Any other tasks associated with the day-to-day functioning of the DM Team as per the discretion and delegation of the Line Manager.

Minimum Qualifications & Experience:

• Graduate in a clinical or life sciences related field.
• Relevant experience/qualifications in allied professions may also be considered.
• Preferably at least six months to one year experience working in the research, pharmaceutical industry or a related field.