Clinical Trial Manager
vor 2 Monaten
ABOUT THE ROLE Combining the most advanced and least-invasive rhythm management technologies available with an unwavering commitment to deep collaboration with healthcare professionals, we're helping to reduce costs, improve outcomes and enhance patients' lives.
The Clinical Trial Manager is responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide as well as leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization.
Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area.
WHAT WILL YOU BE RESPONSIBLE FOR? Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice.
Efforts and leadership support product approval, indication expansion and claim support, and mandated post market requirements.Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies.
May lead studies executed by a CRO.Provides clinical input for new product development, post market surveillance, recertification and business development.
Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables.Interacts with regulatory agencies as needed and will use their scientific knowledge in order to provide directives to staff as well as study sites.Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT/PIB, etc.
).May manage clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.
May author scientific abstracts and/or publications.Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc.KEY COMPETENCIES REQUIRED FOR SUCCESS Leadership: Acts as a resource and mentor for colleagues with less experience.
May lead projects with manageable risks and resource requirements, often broader, cross-functional projects.Functional Expertise: Stays up to date in area of expertise and demonstrates use of that knowledge to successfully achieve goals and objectives.Global Perspective: Understands the position of the organization within a global context and adopts and helps others to adopt a global approach.
Leverages solutions that are scalable, efficient, and cost effective.
Encourages others to share knowledge to ensure success of team, business unit, and organization.Collaboration: Works effectively with others across the team to achieve goals.
Demonstrates proficient communication and partnership in interactions with others.Relationship Building: Establishes and maintains strong relationships internally and externally.
Contributes to a culture of respect, diversity, and inclusion.
Earns the respect and trust of others through effective interpersonal skills, integrity and authenticity.Customer Focus: Identifies internal / external customer needs and ensures the effective delivery of high-quality solutions, products and services that meet or exceed customer expectations.Communication: Creates an environment which promotes the free flow of communication and information throughout the team.
Communicates effectively in large and small groups.
Openly shares knowledge and expertise.
Listens actively and encourages the open expression of ideas and opinions.Planning: Implements initiatives and plans that align with individual and team objectives.
Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success.Execution: Pursues all assignments and projects until completion.
Follows through on assignments to ensure successful completion.SKILLS AND QUALIFICATIONS 7+ years of related work experience or an equivalent combination of education and work experience.3+ years of experience managing clinical trials.Experience leading clinical trials with investigational devices desired, specifically in the field of electrophysiology or cardiology.
Atrial fibrillation/flutter ablation knowledge is strongly preferred.Strong preference for a professional with a wide range of experience and expertise in a specialized technical field.Ability to apply comprehensive technical knowledge of electrophysiology to resolve complex issues in creative ways.Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships.Experience working with and managing external vendors.Ability to travel across Australia and New Zealand and other countries worldwide.Requisition ID: 591163
#J-18808-Ljbffr
-
Project Manager Ii
Vor 5 Tagen
Melbourne, Österreich Avance Clinical Pty VollzeitJoin our amazing Project Management team!Great culture with long term career options.Flexible working available.01st November, 2024If you are an experienced clinical trials Project Manager, then we'd love to hear from you.We're Australia's fastest growing CRO!We have a number of new (Australian based) Project Management roles (Project Manager I & Project...
-
Clinical Trial Manager
vor 2 Monaten
Melbourne, Österreich Precision Medicine Group, Llc. VollzeitClinical Trial Manager (Australia) - Clinical Trial ServicesLocation: Remote AustraliaJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4734We have a current opportunity for an experienced Clinical Trial Manager in Australia!Join our growing team.Precision for Medicine is a precision medicine...
-
Clinical Trials Investigator
vor 2 Monaten
Melbourne, Österreich Nes Fircroft VollzeitClinical Trial InvestigatorPosition: Full-Time & Part-Time opportunities availableAre you a dedicated Medical Doctor with an interest to step into Clinical Trial Research?This could be the perfect opportunity for you to make a significant impact!Join this team in a dynamic clinic setting where you'll engage directly with patients and contribute to essential...
-
Clinical Trials Assistant
vor 1 Monat
Melbourne, Österreich Melanoma and Skin Cancer Trials (MASC Trials) VollzeitAlfred 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 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 Assistant
vor 1 Monat
Melbourne, Österreich Melanoma and Skin Cancer Trials (MASC Trials) VollzeitAlfred 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 southeast suburbs of Melbourne, from ambulatory to inpatient and home and community-based services.Fixed Term – 12 month contract – with possibility to extend Full-time: 76 hours...
-
Clinical Trials Coordinator
vor 2 Monaten
Melbourne, Österreich Healthcare Professionals Group VollzeitAbout the companyOur client is a leading healthcare institution located on the Sunshine Coast, known for its commitment to advancing clinical research and providing exceptional patient care.They are currently expanding their oncology and rheumatology trial offerings and are looking for a skilled Clinical Trial Coordinator to join their dynamic team.About the...
-
Clinical Trial Assistant
vor 3 Wochen
Melbourne, Österreich https:www.linkedin.comcompany1050159 VollzeitAbout usLinear Clinical Research is an internationally recognised clinical trial company which delivers life-changing therapies to patients and participants through clinical trials across a broad range of therapeutic areas.Our state-of-the-art Advanced Clinical Trial Centre (ACTC) opened in Feb 2024 at Sir Charles Gairdner Hospital and is where our teams of...
-
Clinical Project Manager
vor 1 Monat
Melbourne, Österreich Linear Clinical Research VollzeitClinical/Medical Research (Healthcare & Medical) Full time Founded by the Harry Perkins Institute, Linear Clinical Research is at the forefront of human breakthroughs, contributing to scientific discovery and advancement through world-leading clinical human trials and medical research.Our Early Phase Unit delivers clinical trials across various therapeutic...
-
Clinical Trial Team Leader
vor 1 Monat
Melbourne, Österreich Austin Health VollzeitLocation: Melbourne | Northern MetropolitanJob type: Full Time - Fixed TermOrganisation: Austin HealthOccupation: Health and Allied HealthReference: 1840An exciting opportunity to join Austin Cancer Clinical Trials Centre (CCTC) as a Clinical Trials Team Leader. We are seeking a full-time employee (40hrs with ADO) to cover maternity leave in our Haematology...
-
Clinical Trial Team Leader
vor 1 Monat
Melbourne, Österreich Austin Health VollzeitLocation: Melbourne | Northern MetropolitanJob type: Full Time - Fixed TermOrganisation: Austin HealthOccupation: Health and Allied HealthReference: 1840An exciting opportunity to join Austin Cancer Clinical Trials Centre (CCTC) as a Clinical Trials Team Leader. We are seeking a full-time employee (40hrs with ADO) to cover maternity leave in our Haematology...
-
Clinical Trial Coordinator
vor 2 Wochen
Melbourne, Österreich Alfred VollzeitAlfred 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 Scientist Grade...
-
Clinical Trial Coordinator
vor 2 Wochen
Melbourne, Österreich Alfred VollzeitAlfred 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.Position Details:Fixed term appointment until December 2025Full time (76 hours per...
-
Clinical Trial Coordinator
vor 2 Wochen
Melbourne, Österreich Alfred VollzeitAlfred 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.Position Details: Fixed term appointment until December 2025Full time (76 hours per...
-
Clinical Trial Coordinator
vor 2 Wochen
Melbourne, Österreich Alfred VollzeitAlfred 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 Scientist Grade...
-
Clinical Trial Coordinator
vor 2 Wochen
Melbourne, Österreich Alfred VollzeitAlfred 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 Scientist Grade...
-
Clinical Trial Team Leader
vor 1 Monat
Melbourne, Österreich Austin Health VollzeitLocation: Melbourne | Northern MetropolitanJob type: Full Time - Fixed TermOrganisation: Austin HealthOccupation: Health and Allied HealthReference: 1840An exciting opportunity to join Austin Cancer Clinical Trials Centre (CCTC) as a Clinical Trials Team Leader.We are seeking a full-time employee (40hrs with ADO) to cover maternity leave in our Haematology...
-
Clinical Trial Team Leader
vor 1 Monat
Melbourne, Österreich Austin Health VollzeitLocation: Melbourne | Northern Metropolitan Job type: Full Time - Fixed Term Organisation: Austin Health Occupation: Health and Allied Health Reference: 1840 An exciting opportunity to join Austin Cancer Clinical Trials Centre (CCTC) as a Clinical Trials Team Leader.We are seeking a full-time employee (40hrs with ADO) to cover maternity leave in our...
-
Clinical Trial Team Leader
vor 1 Monat
Melbourne, Österreich Austin Health VollzeitLocation: Melbourne | Northern MetropolitanJob type: Full Time - Fixed TermOrganisation: Austin HealthOccupation: Health and Allied HealthReference: 1840An exciting opportunity to join Austin Cancer Clinical Trials Centre (CCTC) as a Clinical Trials Team Leader. We are seeking a full-time employee (40hrs with ADO) to cover maternity leave in our Haematology...
-
Clinical Trial Team Leader
vor 1 Monat
Melbourne, Österreich Austin Health VollzeitLocation: Melbourne | Northern MetropolitanJob type: Full Time - Fixed TermOrganisation: Austin HealthOccupation: Health and Allied HealthReference: 1840An exciting opportunity to join Austin Cancer Clinical Trials Centre (CCTC) as a Clinical Trials Team Leader.We are seeking a full-time employee (40hrs with ADO) to cover maternity leave in our Haematology...
-
Clinical Trial Coordinator
vor 1 Monat
Melbourne, Österreich Alfred Health VollzeitAlfred 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 November 2025Full time (76 hours per fortnight)Medical...
