Senior Clinical Data Manager

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 and New Zealand.

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.

Due to continued growth and a strong project pipeline, we’re looking for a talented Senior Clinical Data Manager to join our team in Australia.

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 Data Management Team Leader, you will be responsible for:

• Coordinating, performing and leading study start up tasks;
• Reviewing CRF design;
• Developing the Data Management Plan;
• Specification of consistency checks;
• Performing user acceptance testing;
• Developing data transfer specifications;
• Developing and working to plans and procedures;
• Planning, executing and coordinating data cleaning activities including;
• Generation of data queries;
• Performing manual checks;
• Reconciliation of data from electronic sources;
• SAE reconciliation;
• Medical coding;
• Preparing the database for locking, ready for analysis;
• Delivering training to internal staff as well as sites, clients and vendors; and
• Perform additional duties as assigned.
  

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

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines;
• A minimum of 2 years’ experience as a Data Manager in a CRO or Pharmaceutical Company;
• Experience with Zelta or Viedoc EDC is preferred;
• A good working knowledge of ICH-GCP, GCDMP, CDISC and Biometrics related guidelines;
• A demonstrated ability to work well in a team, be adaptable and flexible, with a positive attitude and a willingness to learn;
• Superior organisation and planning skills and the ability to deliver work according to study timelines and within the project budget;
• A high level of written and verbal communication skills; and
• An exceptional level of attention to detail
  

Why Southern Star Research?

Southern Star Research is a growing business and this is an ideal opportunity for someone who is looking to progress their data management skills by being involved in all aspects of data management across a range of different therapeutic areas. 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;
• Solid career pathways and progression in a growing company
• Career stability and security;
• Head Office located in Gordon, Sydney – Under cover parking provided and close to public transport; and
• STAR day – one extra day off per year to recharge.
  

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.