Clinical Data Manager

About the Role

The Clinical Data Manager’s role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices.

Responsibilities

• Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated
• Input into the preparation of RFP’s in liaison with BD and the clinical team.
• Liaison with the project team and client for preparing and maintaining Data Management Plans. Responsible for all aspects of data management 
• Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned.
• Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general.
• Participation in industry forum (conferences, professional association committee work etc) as a means of professional development as well as promotion of Novotech’s image in industry. 

Qualifications & Experience:

• Graduate in a clinical or life sciences related field. 
• At least four to eight years' experience in a similar role 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 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.

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.