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.
Due to continued growth and a strong project pipeline, we're looking for talented Data Management Team Leader to join our team in Sydney, Australia.
Other locations in Australia will be considered.
If you're interested in joining an innovative, exciting, Australian owned CRO, we'd love to talk to you.
About the roleReporting to the Head of Data Management, you'll be responsible for:
Line management of a team of Data Managers ensuring alignment with project goals, quality standards, and timely deliverables;Implement effective strategies for data cleaning and reconciliation, ensuring high-quality and accurate clinical data;Assist in the recruitment process for new Data Management team members;Oversee the training and onboarding of all team members;Plan and execute DM projects following Southern Star Research SOPs, while working with both internal and external stakeholders to meet project goals;Oversee the creation of plans, guidelines, training materials, and other essential DM documentation to facilitate smooth data collection and review processes;Lead user acceptance testing of electronic case report forms (eCRFs) and consistency checks to ensure quality and accuracy;Supervise the medical coding process and review of coded terms to ensure proper classification and consistency;Ensure the collection and filing of all Data Management-related documentation in the Trial Master File (TMF), adhering to Good Documentation Practices;Contribute to the development and review of Standard Operating Procedures (SOPs) and processes to improve operational efficiency;Ensure familiarity with and compliance to CDISC, GCP, GCDMP, and other relevant guidelines to uphold the highest standards of data quality and regulatory compliance;Participate in business development activities as required;Perform the duties of a Senior Data Manager as needed; andPerform additional duties as required.To be successful in the role, we're looking for candidates with:A minimum of 7 years' experience in clinical data management, preferably in the CRO environment;Prior line management experience is preferred but not essential;A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;Strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity;Demonstrated business ethics and integrity;Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.Why Southern Star Research?Southern Star Research is a growing business within the Asia Pacific region, this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and develop their leadership experience within data management.
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 all the requirements of this role, but still interested?
Please still apply!
Inclusivity, Diversity and EqualityOur 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.
#J-18808-Ljbffr