Clinical Trial Manager

1 day ago


Newcastle, Australia Pharmiweb Full time
As a Clincal Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Trial Manager will be responsible for all operational aspects of multiple projects/programs such as Compassionate Use Programs, Investigator-Initiated (IIS) Studies, and Collaboration Studies

What you will be doing:

  • Has operational responsibility across multiple projects/program(s) with minimal direction: Compassionate Use, Expanded Access Programs, IIS, and Collaboration studies
  • Accountable for financial forecasting accuracy of Medical Study Operartions for studies within span of responsibility.
  • Maintainance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforcaseted as necessary, and brand give back are fully assessed.
  • Maintains fianancial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies.
  • Reponsible for managing drug supply for Compassionate Use and IIS programs, as appropriate.
  • Manages vendors and financial tracking as required per program
  • Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency


You are:

  • Minimum of Bachelors Degree (advanced degree preferred).
  • Minimum four to six years clinical trial management experience
  • Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.)
  • 5 - 7 years’ experience working in area(s) of research and/or regulatory and/or a field-based function in pharmaceutical and/or biotech company (ies).
  • Ideally, the incumbent will have a science background with active experience in aforementioned areas, ideally in the therapeutic areas of inflammation/immunology/antibody research.
  • Incumbent must have track record of working well in a dynamic environment, must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different stakeholders (clinical, pre-clinical, commercial, external customers).


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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.

  • Newcastle, New South Wales, Australia Calvary Care Full time

    About the RoleWe are seeking an experienced and skilled Clinical Trials Administration Officer to join our team at Calvary Care. As a key member of our Clinical Trials Unit, you will be responsible for providing administrative support to our team of clinical trial coordinators and managers.Key ResponsibilitiesProvide administrative support to the Clinical...


  • Newcastle, New South Wales, Australia Calvary Care Full time

    About the RoleWe are seeking a highly organized and detail-oriented individual to join our team as a Clinical Trials Administration Officer at Calvary Mater Newcastle.Key ResponsibilitiesProvide administrative support to the Clinical Trial Unit Manager, including basic filing, roster management, meeting management, and minute taking.Manage Kronos payroll...

  • Clinical Trial Fellow

    3 months ago


    Newcastle, Australia Calvary Full time

    #524456 Early Phase Clinical Trial Fellow Department of Medical Oncology Calvary Mater Newcastle Temporary Full-Time or Part -Time Fixed-Term (12 months) Full-Time or Part-Time About the Role The Early Phase Medical Oncology Clinical Trial Fellow at the Calvary Mater Newcastle will be joining one of the busiest clinical trial units in New South Wales....


  • Newcastle, Australia Calvary Full time

    #526302 Administration Officer Haematology Clinic Calvary Mater Newcastle Temporary Full Time Fixed-Term (3 Years) Full-Time **Salary Classification**: Administration Officer Level 3, 1-2 years **Remuneration**: $33.30 - $34.33 per hour + superannuation + annual leave loading + salary packaging options + RDO’s. **THE ROLE**: The Administration Officer is a...


  • Newcastle, Australia Calvary Care Full time

    #526302 Administration Officer Haematology Clinic Calvary Mater Newcastle Temporary Full Time Fixed-Term (3 Years) Full-Time Salary Classification: Administration Officer Level 3, 1-2 years Remuneration: $33.30 - $34.33 per hour + superannuation + annual leave loading + salary packaging options + RDO’s. THE ROLE: The Administration Officer is a...


  • Newcastle, Australia Calvary Full time

    #521074 Clinical Trial Data Manager Department of Haematology Fixed Term Full-Time Calvary Mater Newcastle Fixed-Term Full-Time (3 Years) Non-recurrent funding. **Classification**: Administration Officer Level 3 Year 1-2. **Remuneration**: $33.30 - $34.33 per hour, excluding superannuation. Be involved in research for our cancer patients receiving new...


  • Newcastle, New South Wales, Australia Pharmiweb Full time

    Job SummaryThe Senior Study Start-Up Specialist is responsible for managing and conducting start-up activities in compliance with client procedures, documents, local and international guidelines such as ICH-GCP and relevant regulations.Key ResponsibilitiesContribute to ensure that clinical and operational feasibility assessment of potential studies is...


  • Newcastle, New South Wales, Australia Pharmiweb Full time

    Clinical Research Associate II Specialist Job DescriptionICON 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.Key Responsibilities:Conduct site...


  • Newcastle, New South Wales, Australia Pharmiweb Full time

    Job Title: Senior Clinical System DesignerAt ICON, we're seeking a highly skilled Senior Clinical System Designer to join our team. As a key member of our clinical data management team, you'll play a critical role in designing and implementing clinical data management systems that meet the needs of our clients and their clinical trials.Key...


  • Newcastle, Australia Pharmiweb Full time

    Clinical System Designer - Patient Platform designs ICON 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. Clinical System Designer -Patient Platform...

  • Speech Pathologist

    2 weeks ago


    Newcastle, New South Wales, Australia Optimum Health Solutions Full time

    {"About Us": "Optimum Health Solutions is a leading preventative Allied Health service providing holistic multidisciplinary care to children and adults. Our services are provided within state-of-the-art facilities across NSW and TAS.", "About the Role": "This challenging and rewarding role offers a vast variety of client conditions and client streams,...

  • Laboratory Technician

    4 months ago


    Newcastle, Australia Calvary Full time

    #521053 Laboratory Technician - Clinical Trials Department of Medical Oncology Calvary Mater Newcastle Fixed-Term Part-Time Join one of Australia’s leading Clinical Trials Units. **Salary Classification**: Technical Officer Grade 1 Year 1-3. **Remuneration**: $32.13-$33.57 per hour, excluding superannuation. 3 year Part-time (24hrs per week) position...

  • Clinic Manager

    3 months ago


    Newcastle, Australia LCA NEWCASTLE Full time

    Laser Clinics, established in 2008, is the top competitor in non-invasive aesthetic treatments. Our services include laser hair removal, cosmetic injectables, body sculpting, advanced skin treatments, and Skinstitut, our high-performing skincare brand. We are thrilled to share that we have an excellent opportunity for a Clinic Manager to cover a **fixed...


  • Newcastle, New South Wales, Australia Pharmiweb Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for performing site activities for Phase I-IV studies, serving as the main point of contact for the site during a study. Your primary objective will be to drive and execute monitoring plans, ensuring site GCP...

  • Clinical Manager

    4 months ago


    Newcastle, Australia Asquith Workforce Full time

    Embark on a purposeful journey counselling, training, and developing - Supportive team environment - Off-site Car Park **Short Description** Asquith Workforce are supporting a leading provider who is devoted to worker’s wellbeing. They provide an extensive employee assistance program that includes proactive mental health services and training resources...

  • Speech Pathologist

    3 weeks ago


    Newcastle, New South Wales, Australia Optimum Health Solutions Full time

    About the RoleWe are seeking a highly skilled and motivated Speech Pathologist to join our team at Optimum Health Solutions. As a Speech Pathologist with our company, you will have the opportunity to work collaboratively with a multidisciplinary team of Allied Health Professionals to provide holistic care to children and adults.Key ResponsibilitiesAssess and...


  • Newcastle, Australia LCA NEWCASTLE Full time

    Are you a qualified therapist that cares about your continued professional growth and has been wanting to take the next step in your career? This could be your perfect opportunity! We are seeking an Assistant Clinic Manager at our **Charlestown **clinic. As an Assistant Clinic Manager with LCA **Charlestown**, your role will be to provide expert hands-on...


  • Newcastle, Australia Pharmiweb Full time

    Senior Clinical System Designer - Swansea office, Dublin office, UK remote ICON 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. ICON plc is a...


  • Newcastle, New South Wales, Australia Pharmiweb Full time

    Job Summary:The Study Start-Up Manager is responsible for managing and conducting start-up activities in compliance with client procedures, documents, local and international guidelines such as ICH-GCP and relevant regulations. This role requires strong collaboration and communication skills to ensure timely and efficient study start-up activities and...


  • Newcastle, New South Wales, Australia Pharmiweb Full time

    Study Start Up Associate - FranceAt ICON plc, we're committed to fostering an inclusive environment that drives innovation and excellence in clinical research. As a Study Start Up Associate, you'll play a vital role in ensuring the successful start-up of clinical trials at research sites across France.Key Responsibilities:Collect, review, and negotiate...