About The Job
Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. 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 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 a talented full-time Computer Systems Validation Specialist to join our team remotely in either the Philippines, India or Malaysia. You’ll take the lead on maintaining compliance, complete ongoing CSV for established clinical systems, as well as conducting all initial CSV for new system implementation and significant updates.

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 Quality Assurance, you’ll be responsible for:

• Maintain the corporate GXP computerised system inventory.
• Track and manage the conduct of CSV and related tasks for GXP systems.
• Liaise with System Owners to ensure the computerised systems are maintained in a validated state.
• Development or review and approval of proposed and executed Clinical Trial Computerised system change control for CSV related projects (e.g., new system implementations, major upgrades).
• Collaborate with and support the IT team with responsible monitoring of computerised system purchases, installation, validation, continued evaluation to decommissioning of these systems using a risked based approach.
• Review of vendor supplied CSV documentation (e.g., change request, risk assessment, validation plan, software/configuration/functional specifications, IQ/OQ/PQ, traceability matrix, validation report) for suitability during initial assessments and system updates.
• Creation, review and approval of internal CSV documentation (e.g., initial assessment, change control, URS, risk assessment, validation plan, software/configuration/functional specifications, IQ/OQ/PQ, traceability matrix, validation report).
• Create, review and approve CSV SOPs and provide guidance and training to others on CSV SOPs where required.
• Ensure annual reviews of user access and periodic reviews are performed for computerised systems and actively participate in this process through review / approval of the documentation.
• Liaise with System Owners, Head of QA and IT Management to determine CSV needs and strategic goals.
• Ensure regulatory requirements are applied and adhered to as applicable throughout the CSV life cycle of regulated systems.
• Perform CSV activities in accordance with internal SOPs.
• Conduct internal process audits to verify compliance with internal processes and applicable regulatory requirements.
• Assist with vendor assessments and audits conducted by sponsors.
• As required, contribute as a member of the investigational team for CAPAs related to clinical trial systems and CSV.
• Maintain an up-to-date knowledge of the latest requirements relating to CSV, cybersecurity and GCP and regulatory requirements in Australia and overseas.
• Other duties as directed by Line Management or delegate.

Does this sound like you?

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

• Bachelor’s degree (preferably in a science or IT field) or equivalent experience.
• Minimum 2 years’ experience operating in a GCP or GxP environment with experience in a CSV capacity in a GxP (preferably GCP) environment.
• Formal audit exposure.
• Previous experience in Veeva Vault CTMS and/or eQMS experience essential.
• Demonstrated ability to prioritise work, manage multiple priorities and deliver tasks on time with a high degree of accuracy.
• Good written and verbal communication skills with a demonstrated ability to communicate effectively with senior management and other departments.
• Demonstrated ability to work harmoniously and cooperatively with other people and to work independently without supervision.
• A proactive and enthusiastic team player who is willing to identify issues and propose solutions.
• Intermediate - advanced MS Office suite.
  

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and join a passionate team that’s committed to quality, collaboration, and continuous improvement. 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 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.

Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. 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 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 a talented full-time Quality Assurance Auditor to join our team remotely in either the Philippines or Malaysia. You’ll take the lead on our QA Vendor Qualification activities, providing expert oversight on the assessment and management of new and existing vendors. You’ll collaborate with cross-functional subject matter experts and serve as the go-to expert during client audits and regulatory inspections.

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 Quality Assurance, you’ll be responsible for:

• Lead and manage daily vendor qualification operations within the SSR QA team;
• Oversee vendor selection, assessments, and qualifications—including coordination with external auditors;
• Act as subject matter expert in internal forums and vendor-related meetings;
• Build strong relationships with internal teams and external partners to support vendor use and management;
• Conduct vendor scoping and GxP risk assessments; manage new vendor requests;
• Contribute to the development of audit schedules, quality metrics, and reports;
• Drive process improvement by reviewing and updating procedural documentation;
• Support the strategic planning of vendor assurance initiatives; and
• Perform any additional responsibilities as assigned.

Beyond vendor qualification, you’ll also contribute to broader QA activities, including:

• Delivering compliance advice
• Conducting internal and external audits
• Supporting sponsor audits and inspections
• Reviewing and improving QA processes; and
• Perform any additional responsibilities as assigned.

Does this sound like you?

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

• Minimum 5 years’ experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials. CRO experience is preferred;
• Strong knowledge of CRO / Healthcare / Pharmaceutical Vendor Management Quality Assurance activities and understanding of vendor oversight strategies in regulated environments is essential;
• Strong background in QA and GxP auditing, especially GCP is essential and experience across other GxP areas (GLP, GPvP, GMP, GDP) is advantageous;
• Critical thinker with a proactive, solutions-focused mindset;
• Ability to travel across the region if required; and
• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and join a passionate team that’s committed to quality, collaboration, and continuous improvement. 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 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.

Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. 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 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 a talented full-time Veeva Support Specialist to join our team remotely in either the Philippines or Malaysia. We are seeking an experienced Subject Matter Expert (SME) in Veeva Vault Clinical Trial Management System (CTMS) and eTMF to support the ongoing success of our clinical operations. In this key role, you will take ownership of the system’s configuration, maintenance, compliance, and user support, ensuring our trials run smoothly and efficiently.

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 Clinical Operations, you’ll be responsible for:

• Lead the setup, configuration, and ongoing management of Veeva Vault CTMS and eTMF systems;
• Oversee user roles, permissions, and workflow configurations to meet evolving project needs;
• Support study teams with document management processes and ensure regulatory compliance;
• Monitor TMF for completeness, accuracy, and audit readiness;
• Manage document upload, classification, indexing, version control, and QC review processes;
• Maintain high standards of data integrity and ensure reconciliation across systems;
• Provide user training, technical support, and system troubleshooting as the first point of contact;
• Collaborate with study teams to ensure timely and complete filing of trial documents;
• Develop and maintain SOPs, work instructions, and training materials;
• Coordinate system-related tasks such as archiving and report configuration;
• Identify and drive continuous improvements in processes and system usage;
• Assist with integration between Veeva Vault and other clinical applications;
• Partner with IT teams and Veeva support to resolve system issues and improve interoperability; and
• Perform any additional responsibilities as assigned.

Does this sound like you?

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

• Minimum 3 years’ experience working with Veeva Vault CTMS and eTMF within a pharmaceutical company or CRO focused on clinical trials. CRO experience is preferred;
• Experience in clinical trials and a good understanding of GCP and regulatory requirements;
• Excellent interpersonal, planning and communication skills with the ability to work in a dynamic environment with competing projects and deadlines;
• High degree of computer literacy specifically experienced in Word, Excel, Power Point, Outlook, Web-Browser applications and capable of learning new systems; and
• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region. 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 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.

Southern Star Research is a leading Australian, full service 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 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, full-time Senior Clinical Research Associate or Clinical Research Associate to join our team in Melbourne, 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 Senior Clinical Team Leader, you’ll be responsible for:

• Conducting site qualification, interim monitoring and study closeout visits;
• Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines;
• Act as a central point of contact at investigator meetings and site initiation visits;
• Manage all aspects of the clinical monitoring process;
• Build and develop relationships with site stakeholders;
• Identify, evaluate and recommend new potential investigators and sites on an ongoing basis; and
• Mentoring of junior Clinical Research Associate's.
  

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

• A minimum of 5 years experience in clinical research and 2 years of independent monitoring experience for a SCRA or a minimum of 1 year of independent monitoring for a CRA;
• A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
• 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. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated;
• 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 and this is an ideal opportunity for someone who is looking to be involved in all aspects of clinical trials 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;
• 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.

About the job

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/Database Developer 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 Head of Data Management, you will be responsible for:

• Ownership of all technical aspects of the eCRF and Clinical Database build activity;
• Development of Clinical Databases, including additional modules for medical coding of data, randomisation of participants and any other optional modules as required;
• Design and build unique CRF pages;
• Make updates the eCRF and database as identified during the UAT;
• Enabling the eCRF go-live;
• Locking the eCRF at the end of the study;
• Specification of consistency checks;
• Programming of consistency checks;
• Identification and resolution of database issues;
• Developing data transfer specifications;
• Developing and working to plans and procedures;
• Delivery of training to internal staff as well as sites and clients; 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 database developer in a CRO or Pharmaceutical Company;
• A minimum of 5 years’ data management experience;
• Certification in Zelta or Viedoc EDC;
• An ability to translate protocol requirements into a structured database;
• An understanding of different database user role requirements;
• 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 and database development 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.

About the job

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 full-time Senior/Project Manager's 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 Head of Projects, you’ll be responsible for:

• Proactively managing all aspects of the trial process including trial timelines, budgets, resources and vendor relationships;
• Acting as the central point of contact for all client trial enquiries;
• Preparing and managing project plans as well as implementing quality standards and risk mitigation strategies as required;
• Managing a cross-functional project team through all phases of the clinical trial;
• Leading sponsor study start-up process, including kick off meetings, site selection as well as other various agreements and budgets;
• Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs and ICH/GCP guidelines;
• Development and review of documents to ensure alignment with standard operation procedures and local regulations;
• Lead assigned team/s in the delivery of contracted project services; and
• Train and mentor project team members and other staff as needed.

Does this sound like you?

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

• Minimum 5 years of experience working in clinical research in a pharmaceutical company, CRO or other research setting;
• 2+ years of experience as an independent Project Manager;
• HV, Oncology and/or Radio-Oncology experience is preferred;
• International Project Management Experience across APAC and US is preferred;
• A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
• A sound knowledge and understanding of ICH-GCP;
• Exposure to a broad range of trials across multiple therapeutic areas;
• Ability to work independently; and
• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to be involved in all aspects of clinical trials across a range of different therapeutic areas and progress their skills in project 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

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.