Manager, Data Management

Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and the Asia Pacific region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients’ projects and to the Company. Southern Star Research’s culture is focused on fostering and maintaining a positive, professional and productive work environment.

We are looking for a talented, full-time Manager, Data Management to join our team in Australia too lead our talented team of Data Managers and Database Developers.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About The Role

Reporting to the Head of Biometrics, you’ll be responsible for:

• Lead and manage the Data Management department, including line management of direct reports;
• Allocate appropriate resources to projects, ensuring timelines and budgets are met;
• Offer technical guidance to team members and provide expert support to clients and stakeholders;
• Drive operational efficiency of the Data Management department;
• Collaborate with Project Managers and the Contracts team to identify and manage out-of-scope work and budget adjustments;
• Develop and implement efficient strategies for database/eCRF setup and data cleaning;
• Participate in the recruitment, onboarding, and training of new Data Management team members;
• Oversee the planning and delivery of Data Management activities in compliance with SOPs and regulatory requirements;
• Lead the creation of study-specific documentation, including plans, checklists, guidelines, and training materials;
• Ensure high-quality Data Management input into study protocols;
• Manage relationships with Data Management vendors and consultants;
• Ensure complete, accurate, and timely filing of Data Management documentation in the Trial Master File (TMF);
• Contribute to the ongoing development and review of Standard Operating Procedures;
• Ensure timely and accurate timesheet completion;
• Uphold and promote the ethics and quality values of Southern Star Research;
• Step in as a Data Manager or Database Developer when necessary; and
• Perform additional responsibilities as assigned.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

• Minimum 15 years’ experience as a Data Manager or Database Developer preferably in the CRO industry;
• Expert knowledge of Data Management in clinical trial environment and the necessary skills to evaluate Data Management processes, develop strategies for improvement and execute on those strategies;
• Prior line management experience is essential;
• Certification in Zelta and/or Viedoc is desirable;
• Experience across a variety of phases of clinical trials is beneficial;
• Knowledge of CDISC;
• Knowledge of GCP regulatory environment for Data Management;
• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is an expanding business within the Asia Pacific region and this is an ideal opportunity to support the development and growth of our data management department. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We Offer

• An attractive remuneration and benefits package;
• Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
• We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
• Career stability and security;
• Office located in Gordon – under cover parking provided and close to public transport;
• STAR day – one extra day off per year for you to recharge and more!

We’d love to connect with you!

Don’t have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.