Clinical Data Risk Management Specialist

3 days ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Clinical Data Risk Management Specialist

We are seeking a skilled Clinical Data Risk Management Specialist to join our team at ICON. As a Clinical Data Risk Management Specialist, you will be responsible for the set-up and implementation of Central Monitoring on a portfolio of clinical studies. This is an exciting opportunity to work with a world-leading healthcare intelligence and clinical research organization.

Key Responsibilities:
  • Recognize, exemplify and adhere to ICON's values, which center on Collaboration, Agility, Integrity and Inclusion
  • Creation and ownership of the Central Monitoring Plan
  • Provide input to study risk assessment and propose appropriate and tailored risk indicators for central analysis, in line with holistic data monitoring model.
  • Support set-up and testing of data analysis platform
  • Review clinical study data and make independent decisions to identify potential site performance and site organization issues.
  • Manage operational risk log for Clinical Risk Management activities.
  • Train and support the project teams about interpretation of Central Monitoring Signals and relevant decision making for study conduct.
  • Support preparation, conduct and follow-up of the Quality Risk Review Meetings for effective communication with the cross functional project team to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issues.
  • Oversee Clinical Risk Management project budget, scope of work, forecasting.
  • Communicate effectively with the project team: CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical staff, Scientific Council to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issue.
  • Support cross functional and external Data Analysis Platform users with system use.
  • Act as mentor for Central Monitoring team members.
  • Travel (approximately 5%) domestic and/or international.
  • Other duties as assigned.
Requirements:
  • University/Bachelor's Degree in medicine, science or equivalent degree/experience
  • Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring
  • 3-4 years' experience in Clinical Research (CRA or DM background), or relevant skillset
  • Knowledge of database technologies and processes
  • Fluent in written and spoken English.
  • Excellent communication and interpersonal skills, attention to detail
  • Demonstrate ownership and accountability for achieving results.
  • Ability to work within a team environment and manage competing priorities in a changeable environment.
  • Proven Functional Lead skills and the ability to work independently and apply critical thinking skills to resolve study related issues.
What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family's needs

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

  • Senior Clinical Data Specialist

    4 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Senior Clinical Data SpecialistAt Pharmiweb, we're seeking a highly skilled Senior Clinical Data Specialist to join our team. As a key member of our data management team, you will be responsible for performing ongoing data review, including reconciliation of third-party data streams and serious adverse event reconciliation with the safety...

  • Senior Clinical Data Science Lead

    3 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Senior Clinical Data Science LeadWe are seeking a highly skilled Senior Clinical Data Science Lead to join our team at ICON plc. As a key member of our Biotech Government and Public Health division, you will be responsible for leading clinical data science activities and ensuring the delivery of high-quality data for analysis.Key...

  • Clinical Data Lead

    4 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    About ICONICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Job SummaryWe're seeking a highly skilled Clinical Data Lead to join our team. As a...

  • Clinical Data Science Lead

    3 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Principal Clinical Data Science LeadAt ICON, we're committed to advancing and improving patients' lives through innovative clinical development solutions. As a Principal Clinical Data Science Lead, you'll play a critical role in driving our mission forward.Key Responsibilities:Provide expert oversight and guidance on clinical data management and...

  • Clinical Trial Manager II

    3 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Clinical Trial Manager IIAs a Clinical Trial Manager II, you will be part of a dynamic team at ICON, a leading global provider of clinical research services. We are seeking an experienced professional to manage and prioritize clinical deliverables, ensuring quality and regulatory requirements are met.Key Responsibilities:Manage and prioritize...

  • Clinical Trial Data Analyst

    5 days ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Clinical Trial Data Analyst Job DescriptionAre you a detail-oriented and analytical professional looking for a challenging role in the pharmaceutical industry? Do you have experience in data analysis and a passion for working with clinical trials?We are seeking a Clinical Trial Data Analyst to join our team at Pharmiweb. As a Clinical Trial Data Analyst, you...

  • Clinical Data Lead

    4 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    About the RoleWe are seeking a highly skilled Clinical Data Lead to join our team at ICON plc. As a Clinical Data Lead, you will be responsible for providing leadership and expertise in clinical data management, ensuring the delivery of high-quality clinical data to support our clients' needs.Key ResponsibilitiesProvide leadership and guidance to clinical...

  • Clinical Research Associate II Specialist

    3 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Clinical Research Associate II SpecialistAt ICON, we are seeking a highly skilled Clinical Research Associate II Specialist to join our team. As a Clinical Research Associate II Specialist, you will play a critical role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative...

  • Clinical Research Associate II Specialist

    5 days ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job SummaryWe are seeking a Clinical Research Associate II Specialist to join our team. As a Clinical Research Associate II Specialist, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.Key ResponsibilitiesConduct site...

  • Clinical Trial Manager II

    3 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Clinical Trial Manager IIAs a Clinical Trial Manager II, you will be responsible for managing and prioritizing clinical deliverables to ensure quality and regulatory requirements are met. You will work closely with cross-functional teams to achieve successful delivery of data.Key Responsibilities:Manage and prioritize clinical deliverables to...

  • Clinical Research Associate II Specialist

    5 days ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job SummaryWe are seeking a skilled Clinical Research Associate II Specialist to join our team at ICON. As a Clinical Research Associate II Specialist, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.Key...

  • Clinical Trial Manager II

    3 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Clinical Trial Manager IIAs a Clinical Trial Manager II, you will be part of a dynamic team responsible for managing clinical trials from start to finish. Your primary focus will be on ensuring the successful execution of clinical trials, meeting quality and regulatory requirements, and delivering high-quality data to our clients.Key...

  • Clinical Study Operations Manager

    4 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Clinical Study Operations ManagerWe are seeking a highly skilled Clinical Study Operations Manager to join our team at ICON plc. As a Clinical Study Operations Manager, you will be responsible for the overall management of clinical studies, ensuring timely and efficient delivery of high-quality results.Key Responsibilities:Develop and implement...

  • Clinical Research Associate II Specialist

    4 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Clinical Research Associate II SpecialistICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to be a part of our mission to shape the future of clinical development.Key Responsibilities:Conduct site qualification,...

  • Senior Specialist

    1 month ago

    Darwin, Northern Territory, Australia Australia Red Cross Full time

    About the RoleThe Senior Specialist - Data Privacy plays a pivotal role in ensuring Australian Red Cross manages its information, including sensitive information, in alignment with the requirements of the Privacy Management Framework. This role guides individuals and teams to effectively implement all components of the Privacy Management Framework and...

  • Clinical Documentation Specialist

    4 weeks ago

    Darwin, Northern Territory, Australia Healthscope Full time

    About the RoleAs a Clinical Documentation Specialist at Healthscope, you will play a pivotal role in shaping the future of healthcare delivery. Your meticulous attention to detail and expertise in clinical documentation will directly impact patient care outcomes, driving positive change and setting new standards of excellence.Key Responsibilities:Reviewing...

  • Clinical Nurse Specialist

    4 weeks ago

    Darwin, Northern Territory, Australia Healthscope Full time

    Job Title: Clinical Nurse SpecialistAt Healthscope, we are seeking a highly skilled and experienced Clinical Nurse Specialist to join our team. As a Clinical Nurse Specialist, you will play a critical role in delivering high-quality patient care and contributing to the development of our nursing team.Key Responsibilities:Deliver high-quality patient care by...

  • Clinical Nurse Specialist

    1 month ago

    Darwin, Northern Territory, Australia Australian Regional & Remote Community Services Full time

    About the RoleAustralian Regional & Remote Community Services (ARRCS) is seeking a skilled Registered Nurse to fill the position of Nurse Specialist. This role will provide clinical leadership, advice, and support to our facilities across the Northern Territory.Key ResponsibilitiesProvide clinical leadership and expertise in palliative care, infection...

  • Data Entry Specialist

    1 month ago

    Darwin, Northern Territory, Australia Grace Worldwide (Australia) Pty Limited Full time

    {"About the Role": "At Grace Worldwide (Australia) Pty Limited, we are seeking a skilled Data Entry Specialist to join our team. This role is responsible for delivering high-quality data entry of Records Management metadata for our diverse clients. As a key member of our Information Management team, you will contribute to the daily operations and learn...

  • Clinical Project Manager

    4 weeks ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    Job Title: Clinical Project ManagerWe are seeking a highly skilled Clinical Project Manager to join our team. As a Clinical Project Manager, you will be responsible for the overall direction, coordination, and implementation of global cross-functional or single service projects.Key Responsibilities:Lead the planning and implementation of cross-functional...