Job Description

:

About the Opportunity :

The Clinical Data Manager\xe2\x80\x99s (CDM\xe2\x80\x99s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP).

Minimum Qualifications & Experience:

• Graduate in a clinical or life sciences related field.
• At least 4-8 years\' experience in a similar role working in the research, pharmaceutical industry or a related field.
• May act as Project Manager for \xe2\x80\x9cstand-alone\xe2\x80\x9d data management projects.
• Participates in project team meetings as required.
• Input into the preparation of RFP\xe2\x80\x99s in liaison with BD and the clinical team.
• Liaison with the project team and client for preparing and maintaining Data Management Plans.
• Design and review of database structure, validation rules and consistency checks.
• Operation of Clinical Data Management software for data entry of clinical trial results.
• All data cleaning/validation tasks
• Development of all key Data Management Documents
• Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stake holders
• Liaison with external service providers on Data Management projects as appropriate.
• Assist in the development of protocols as required.
• Supervision and training support for junior and contract Data Management staff as required.
• Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.
• Identification of and participation in process improvement initiatives, as required.
• Perform accurate study financial projections and maintain monthly project financials.
• Ensure changes in scope are identified and actioned accordingly.

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 has offices in 11 geographies across the region, and site partnerships with key medical institutions.

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: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.

It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech