Clinical Trials Manager
5 months ago
For Current Gilead Employees and Contractors:
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
**Job Description**:
POSITION OVERVIEW:
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.
You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives. Please note this is a 12-month contract from commencement.
EXAMPLE RESPONSIBILITIES:
- Manages all components of small clinical studies, including Phase I studies.- With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, manages all interactions and deliverables from relevant CROs and vendors.- Typically serves as the key operational contact for Gilead studies; providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.- Defines and develops the study logistics and clinical study plan for assigned clinical studies.- Manages study timelines, including documentation and communications.- Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.- Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.- Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.- Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.- May be required to present at internal or external meetings (i.e., investigator meetings).- Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.- Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.- Assists in training new or less experienced colleagues.- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
**REQUIREMENTS**:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience- PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.- MA / MS with 3+ years’ relevant clinical or related experience in life sciences.- BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.- Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.- Experience managing the work of external vendors.- Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA) grade 26 position with demonstrable proficiency.
Knowledge & Other Requirements- Demonstrated ability to be a fast learner.- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/experti
-
Clinical Trial Associate I
6 months ago
Melbourne, Australia Avance Clinical Full time**Who are we?** We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our...
-
Clinical Trials Manager
2 weeks ago
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeCompany OverviewWe are a pioneering clinical research organization dedicated to advancing medical science through innovative trials. Our team is focused on fostering collaborations that drive breakthroughs in healthcare, and we pride ourselves on creating a culture that prioritizes integrity, quality, and patient welfare.About the OpportunityThis role offers...
-
Clinical Trials Manager
1 month ago
Melbourne, Victoria, Australia Allucent Full timeJob Title: Clinical Trials ManagerWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to the Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.Key...
-
Clinical Trials Manager
5 months ago
Melbourne, Australia The Royal Children's Hospital Full timeLocation: Melbourne | Parkville Job type: Full Time - Fixed Term Organisation: The Royal Children's Hospital **Salary**: $118,000 - $131,000 Occupation: Health and Allied Health Reference: 11595 **The Role**: An exciting opportunity exists for an experienced people leader to join the team at the Children's Cancer Centre (CCC) as the Clinical Trials...
-
Senior Clinical Trials Manager
1 week ago
Melbourne, Victoria, Australia Allucent Full timeCompany OverviewAllucent is a leading provider of clinical trial services, dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials.We are looking for a seasoned professional to join our team as a Sr. Clinical Trial Leader.About the RoleThis is an exciting opportunity to work with a talented team of...
-
Clinical Trials Coordinator
1 month ago
Melbourne, Victoria, Australia Alfred Health Full timeAbout the RoleMASC Trials is seeking a highly organized and detail-oriented Clinical Trials Assistant to provide operational support to the team. The successful candidate will be responsible for ensuring effective collaboration and teamwork in the clinical trial setting, as well as contributing to the broader aims of MASC Trials.Key ResponsibilitiesProvide...
-
Clinical Trials Assistant
1 month ago
Melbourne, Australia Alfred Health Full timeAlfred HealthAlfred Health is a leader in health care delivery, improvement, research and education. We are the main provider of health services to people living in the inner southeast suburbs of Melbourne, from ambulatory to inpatient and home and community-based services. Fixed Term – 12 month contract – with possibility to extendFull-time: 76 hours...
-
Clinical Trials Manager
5 months ago
Melbourne, Australia Gilead Sciences Full timeFor Current Gilead Employees and Contractors: At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals. **Job...
-
Clinical Trial Team Leader
6 months ago
Melbourne, Australia Austin Health Full timeLocation: Melbourne | Northern Metropolitan Job type: Full time, Part time Organisation: Austin Health **Salary**: Salary not specified Occupation: Administration/Secretarial, Human Resources, Legal, Occupational Health and Safety, Medical, Nursing Reference: 50169 An exciting opportunity exists for a Clinical Trial Team Leader position to join Austin...
-
Clinical Trials Consultant
3 weeks ago
Melbourne, Victoria, Australia Boehunter Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Officer to join our client's team in a Clinical Trials Consultant role.As a key member of the team, you will be responsible for providing top-tier medical care to participants in ongoing clinical trials.Deliver high-quality medical services to clinical trial participants, following trial protocols,...
-
Clinical Trials Manager Sydney
7 days ago
Melbourne, Victoria, Australia Thermo Fisher Scientific Full time**Overview of Thermo Fisher Scientific**We are a leading global biotechnology company that enables our customers to make the world healthier, cleaner and safer.Salary:The estimated annual salary for this position is AU$90,000 - AU$110,000, depending on experience.About the JobThis is an exciting opportunity to join our team as a Clinical Trials Manager in...
-
Clinical Trials Pharmacy Technician
1 week ago
Melbourne, Victoria, Australia St Vincent's Hospital Melbourne Full timeJoin Our Team as a Clinical Trials Pharmacy TechnicianWe are seeking a highly skilled and experienced pharmacy technician to join our clinical trials team at St Vincent's Hospital Melbourne. This is an exciting opportunity for a motivated individual to work in a dynamic and supportive environment, providing expert knowledge and skills to assist pharmacists...
-
Melbourne, Victoria, Australia I-Pharm Consulting Australia Pty Ltd Full timeJob OverviewThis is an exciting opportunity to lead the Clinical Trial Operations for a full-service Contract Research Organisation (CRO) that has experienced significant growth. The successful candidate will play a critical role in managing multiple divisions essential to the day-to-day operations of clinical trials, reporting directly to the Chief...
-
Clinical Trials Operations Lead
7 days ago
Melbourne, Victoria, Australia I-Pharm Consulting Australia Pty Ltd Full time**Job Overview**I-Pharm Consulting Australia Pty Ltd is seeking a strategic leader to drive clinical trial success and operational excellence in our Melbourne-based operations. As a Director of Clinical Trial Operations, you will play a critical business role in the line management of multiple divisions.**About the Role**This full-time position reports...
-
Clinical Trials Coordinator
1 month ago
Melbourne, Victoria, Australia Alfred Health Full timeAbout the RoleMASC Trials is seeking a highly organized and detail-oriented Clinical Trials Assistant to provide operational support to the team. The successful candidate will be responsible for ensuring effective collaboration and teamwork in the clinical trial setting.Key ResponsibilitiesProvide administrative support to the research teamEnsure accurate...
-
Clinical Trial Coordinator
2 weeks ago
Melbourne, Australia Alfred Health Full timeAlfred HealthAlfred Health is a leader in health care delivery, improvement, research and education. We are the main provider of health services to people living in the inner southeast suburbs of Melbourne, from ambulatory to inpatient and home and community-based services. Fixed term appointment until December 2025Full time (76 hours per fortnight)Medical...
-
Clinical Trials Coordinator
4 weeks ago
Melbourne, Victoria, Australia Alfred Health Full timeAbout this RoleThe Clinical Trials Administration Support (CTAS) position is responsible for providing indirect patient care and administrative support to the Alfred Dermatology Trials team. This role involves performing administrative duties as directed, coordinating patient and stakeholder appointments, and supporting the clinical trials team through the...
-
Pharmacy Technician Clinical Trials Specialist
4 weeks ago
Melbourne, Victoria, Australia St Vincent's Hospital Full timeAbout the RoleYou will be an active member of the pharmacy clinical trials teams and assist the pharmacists with the delivery of clinical trial pharmacy services with a high degree of autonomy and accountability.Clinical trial support including completing trial paperwork, stock management, trials dispensing, monitoring and billing.Dispensing prescriptions or...
-
Clinical Trials Administration Support
4 weeks ago
Melbourne, Australia Alfred Health Full timeNEW role in Alfred Dermatology Trials - 45.6 Hours per fortnight - up to 3 days/wk with hours flexible - Maximise your take home salary with salary packaging and novated leasing! **Alfred Health** Alfred Health is a leader in health care delivery, improvement, research and education. We are the main provider of health services to people living in the inner...
-
Clinical Trials Pharmacy Technician
2 weeks ago
Melbourne, Victoria, Australia St Vincent's Hospital Full timeAbout the RoleWe are seeking an experienced pharmacy technician to join our clinical trials team as a Clinical Trials Pharmacy Technician. This is a full-time, permanent position based in Fitzroy.The successful candidate will demonstrate expert knowledge and skills in supporting pharmacists with the delivery of clinical trial pharmacy services. As an active...
