Clinical Data Operations Lead

2 weeks ago

Sydney, Australia Telix Pharmaceuticals (APAC) Full time

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. **You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

As the Clinical Data Operations Lead, you will serve as the clinical data steward, playing a pivotal role in maintaining the integrity, quality, and compliance of clinical trial data throughout its lifecycle. You will collaborate closely with our internal clinical team and external organizations to ensure accurate data management and facilitate multi-center data collation. Your keen attention to detail, excellent organizational skills, and ability to prioritize tasks will be key to your success in this role.

**What you'll do**
- Manage clinical trial data in compliance with regulatory standards including but not limited to International Conference on Harmonisation - Good Clinical Practice (ICH-GCP), European Medicines Agency (EMA) guidelines for data archival, and 21CFR Part 11 and Part 312.
- Serve as a steward of clinical trial data, overseeing data quality, integrity, and security. Develop and implement data governance processes to maintain high-quality data.
- Coordinate data transfers between external vendors and the sponsor organization. Ensure that data transfers comply with regulatory requirements.
- Maintain comprehensive documentation of data management activities and ensure compliance with regulatory guidelines.
- Develop procedures for the collection, archival, and management of imaging data in clinical trials.
- Provide training and support to team members and external stakeholders on data management processes, guidelines, and best practices.
- Conduct audits and inspections to ensure data integrity and compliance.
- Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to ensure alignment on data management processes and requirements.

**About you**
- Ideally 5 or more years of experience in clinical trial data management and at least 3 years' experience managing imaging data.
- Qualifications in Health Information Management, Life Sciences or equivalent highly desirable.
- 5+ years' experience in process mapping and improvement.
- Demonstrated understanding of GCP and applicable national and international regulations guiding research and health information management.
- Experience in the use of Electronic Data Capture (EDC) Software, electronic Trial Master File (eTMF) and imaging storing softwares.
- Knowledge of patient/clinical confidentiality protocols.
- Attention to detail, highly developed organisational skills and proven ability to establish priorities and manage tasks.
- Demonstrated ability to work productively both independently and as part of a team.

**Why work at Telix?**

At Telix, we believe **everyone counts**, **we strive to be extraordinary**, and **we pursue our goals with determination and integrity**. You will be part of an engaged and supportive group of colleagues who all have a shared** purpose: to help people with cancer and rare diseases live longer, better quality lives. **Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world.** **We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

  • In-house Clinical Research Associate

    4 weeks ago

    Sydney, Australia Advanced Clinical Full time

    In-House Clinical Research Associate (Australia-wide) **Location**: Sydney NSW, Australia **Requisition Number** **345** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched...

  • In-house Clinical Research Associate

    4 weeks ago

    Sydney, Australia Advanced Clinical Full time

    In-House Clinical Research Associate (Australia-wide) **Location**: Sydney NSW, Australia **Requisition Number** **345** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched...

  • In-house Clinical Research Associate

    2 weeks ago

    Sydney, New South Wales, Australia Advanced Clinical Full time

    In-House Clinical Research Associate (Australia-wide)Location: Sydney NSW, AustraliaRequisition Number345RemoteAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research -...

  • Education and Clinical Lead, Infection Prevention

    3 weeks ago

    Sydney, Australia NSW Clinical Excellence Commission Full time

    **Education and Clinical Lead, Infection Prevention and Control (IPAC)** **Clinical Excellence Commission** **Where you'll be working** The Clinical Excellence Commission (CEC) is committed to providing leadership in safety and quality to improve health care for patients in NSW. The primary focus of the CEC is to promote and support improved clinical...

  • Sr. Clinical Operations Lead

    2 weeks ago

    Sydney, New South Wales, Australia AU21 Alcon Laboratories (Australia) Pty Ltd Company Full time

    ​At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • Clinical Research Associate, Cns, Rare Diseases

    2 weeks ago

    Sydney, New South Wales, Australia Worldwide Clinical Trials Full time

    Requisition Number6072Employment Type:RegularDo you have a passion for mentoring the Next Generation of CRAs field monitors? Are you looking for a position where you will be groomed for a leadership role? If so, this Job Is For YOU. Feel the reward of impacting someone else's career while preparing for a leadership role in clinical trials. Our hiring...

  • Clinical Lead

    2 weeks ago

    Sydney, New South Wales, Australia Achieve Australia Full time

    Join our Practice Leadership team and influence the evolution of disability services at Achieve Australia.Apply now 29th May, 2024 Purpose of the Clinical Lead role The Clinical Lead is responsible for planning, leading, monitoring and evaluating the delivery of clinical services by frontline operations and clinical staff through the provision of leadership,...

  • Clinical Care manager

    2 weeks ago

    Sydney, New South Wales, Australia Lead Group Full time

    Lead Group Healthcare are seeking a Clinical Leader for a beautiful Residential Aged Care Facility located in the NSW Northern Rivers – Tweed Heads.This is a fantastic opportunity to live where other people holiday, whilst working with a highly regarded, medium sized facility that provides a fantastic support system including experienced Clinical...

  • Clinical Data Analyst

    3 weeks ago

    Sydney, Australia Healthcare Professionals Group Full time

    **Benefits**: - Competitive salary and work from home options - Opportunity to work with the richest clinically available data set across ANZ in oncology and genomics - Collaborative and fun start-up culture with a focus on agility and innovation **About the Company**: Join a dynamic start-up in the healthcare sector that thrives on agility and innovation,...

  • Senior Clinical Data Manager – Clinical Research Unit

    2 weeks ago

    Sydney, New South Wales, Australia UNSW Australia Full time

    Why Your Role Matters : As a Senior Clinical Data Manager, you will be a member of the CRU operations team and will have overall leadership and responsibility for developing and implementing high quality data management systems and processes to ensure data compliance, integrity, and security. The role will require stakeholder management with key groups...

  • Senior Clinical Data Manager – Clinical Research Unit

    4 days ago

    Sydney, Australia UNSW Australia Full time

    Why Your Role Matters : As a Senior Clinical Data Manager, you will be a member of the CRU operations team and will have overall leadership and responsibility for developing and implementing high quality data management systems and processes to ensure data compliance, integrity, and security. The role will require stakeholder management with key groups...

  • Data Technician

    1 month ago

    Sydney, Australia Lead Group Full time

    Lead group is currently seeking an experienced Data Technician. In this role, you'll be responsible for a variety of tasks, including installation, commissioning, field repairs, and maintenance. You'll provide technical support to our customers, both independently and as part of a team. Primary Responsibilities: Install conduits, ladders, and containment...

  • Data Technician

    2 weeks ago

    Sydney, New South Wales, Australia Lead Group Full time

    Lead group is currently seeking an experienced Data Technician. In this role, you'll be responsible for a variety of tasks, including installation, commissioning, field repairs, and maintenance. You'll provide technical support to our customers, both independently and as part of a team. Primary Responsibilities:Install conduits, ladders, and containment...

  • Associate Clinical Data Manager

    4 days ago

    Sydney, Australia IQVIA Full time

    **Responsibilities**: - Gather Study Set up requirements through discussion and communication with relevant stakeholders. - Perform Database Set up and validation to ensure quality study design for data collection. - Support validation of new Device integrations. - Perform regular Data cleaning activities to ensure clean data with quality and timely...

  • Clinical Portfolio Lead

    2 weeks ago

    Sydney, Australia On Q Recruitment Full time

    Make an impact in this newly created role supporting cancer research - Well Funded - Highly Collaborative & Well-Respected Team - Home-based role - 1 day in the office per month Join NFP Cancer Trial Group which is making meaningful and innovative advancements in cancer research and improving life expectancy and quality of life. - Make an impact in this...

  • Associate Clinical Data Manager

    2 weeks ago

    Sydney, New South Wales, Australia IQVIA Full time

    Responsibilities: Gather Study Set up requirements through discussion and communication with relevant stakeholders. Perform Database Set up and validation to ensure quality study design for data collection. Support validation of new Device integrations. Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to...

  • Clinical Data Manager

    2 months ago

    Sydney, Australia Novotech Asia Full time

    **Minimum Qualifications & Experience**: - Graduate in a clinical or life sciences related field. - At least four to eight years' experience in a similar role working in the research, pharmaceutical industry or a related field. **Responsibilities** Member of the project team reporting to the Project Manager for integrated projects, the Clinical Data...

  • Clinical Data Manager

    2 months ago

    Sydney, Australia Novotech Asia Full time

    **About the role** The Clinical Data Manager's role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices **Responsibilities** - Responsible for all aspects of data management including design and review of database structure, validation rules and consistency checks - All data cleaning/validation...

  • Clinical Data Manager

    2 weeks ago

    Sydney, New South Wales, Australia Novotech Asia Full time

    Minimum Qualifications & Experience: Graduate in a clinical or life sciences related field. At least four to eight years' experience in a similar role working in the research, pharmaceutical industry or a related field.ResponsibilitiesMember of the project team reporting to the Project Manager for integrated projects, the Clinical Data Manager is responsible...

  • Data Operations Lead

    2 weeks ago

    Sydney, New South Wales, Australia NSW Government -Customer Strategy & Technology Full time

    You're looking to embed yourself in projects of different sizes and become part of a team that's shaping the landscape across NSW.If finding complex technological solutions is your game, we've got the team for you. You're going to help us create seamless operations that result in efficiency for millions of customers.In this role you will Lead the operational...