Senior Clinical Data Manager

About the Role

The Senior Clinical Data Manager provides mentorship to junior staff and can also provide support to the project manager. As a leader within the department the Senior CDM is expected to lead process improvements, new initiatives as well as training of junior colleagues

Responsibilities

• Planning, conducting, and managing all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements, and SOPs.
• 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. 
• May function as Project Manager for “stand-alone” data management projects and participates in project team meetings as required.
• Input into the preparation of RFPs 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 including design and review of database structure, validation rules and consistency checks, operation of Clinical Data Management Systems, and all data cleaning/validation tasks.
• Supervision and training support for junior and contract Data Management staff as required.

Qualifications & Experience:

• Graduate in a clinical or life sciences related field. 
• At least 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.