Regional Clinical Study Manager

5 months ago

Sydney, Australia BeiGene Full time

**Job Description**:

- Job Description
- About the Company:
- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.-
- General Description of the Job:- Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
- Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
- Ensures alignment of regional deliverables with overall study goals- Essential Functions of the job:
- Regional Leadership:- Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study
- Leads external vendors involved in study delivery on a regional level
- Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required
- Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings
- Leads regional operations meetings with all regional study team members- Timelines, Planning and Execution:- Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
- Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these
- Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
- Provides regional input on global study plans as required
- Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs
- Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs
- Ensures regional and country information in study systems and tools is entered and up to date
- Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports
- Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan
- Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region
- Manages the trial data collection process for the region, drives data entry and query resolution
- As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing- Quality:- Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads
- Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations
- Ensures inspection readiness for study in region at any point in time throughout the study life cycle
- Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented
- Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate
- Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared
- Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies
- Contributes to development, optimization and review of work instructions and SOPs as required- Budget and Resources-
- Works with the sourcing team to select and manage regional study vendors
- Manages regional study budgets
- Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities
- Identifies and manages regional team reso

  • Regional Clinical Study Manager/Senior Manager

    2 weeks ago

    Sydney, Australia BeiGene Full time

    Job Description: Job Description About the Company: BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region,...

  • Clinical Study Manager

    1 month ago

    Sydney, New South Wales, Australia Pfizer, S.A. De C.V Full time

    Pfizer Medical Team MemberWe are seeking a highly skilled and experienced professional to join our medical team as a Site Care Partner. This role will play a critical part in ensuring the success of our clinical studies by managing the clinical trials, planning, directing, and communicating timelines.Key Responsibilities:Manage clinical studies, ensuring...

  • Senior Clinical Study Manager

    4 weeks ago

    Sydney, New South Wales, Australia Pfizer Full time

    Unlock New Opportunities in Clinical ResearchPfizer is seeking a highly skilled Senior Clinical Study Manager to join our medical team. As a key member of our team, you will be responsible for managing clinical studies, leveraging your project management skills to plan, direct, create, and communicate timelines. Your goal will be to ensure that clinical...

  • In-house Clinical Research Associate

    6 months 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...

  • Site Care Partner

    4 weeks ago

    Sydney, New South Wales, Australia Pfizer Full time

    About the RolePfizer is seeking a highly skilled Site Care Partner to join our medical team. As a key member of our team, you will be responsible for managing clinical studies and ensuring they are completed within time, budget, and scope.Key ResponsibilitiesDevelop and manage plans to achieve objectives, interpreting internal and external business...

  • Clinical Contracting Manager

    2 weeks ago

    Sydney, New South Wales, Australia 951 Pfizer Limited (Taiwan) Full time

    About the RoleWe are seeking a highly skilled Clinical Contracting Manager to lead our team in executing global studies. As a key member of our clinical operations team, you will be responsible for managing site contracting activities and ensuring timely execution of clinical trials.Key ResponsibilitiesLead site contracting activities for global studies,...

  • Oncology Clinical Study Director

    1 week ago

    Sydney, New South Wales, Australia Astra Zeneca Full time

    We are seeking an experienced Clinical Study Director to join our Oncology team at AstraZeneca. As a key member of our clinical research team, you will be responsible for leading and managing multiple high-profile studies from study feasibility through to study results.This is a broad role that requires excellent knowledge of Clinical Study Management and...

  • Medical Project Manager for Clinical Studies

    5 days ago

    Sydney, New South Wales, Australia Pfizer Full time

    About the RoleWe are seeking a skilled Medical Project Manager to join our team at Pfizer. In this role, you will be responsible for managing clinical studies from planning to execution.ResponsibilitiesDevelop project plans and timelines to ensure timely completion of clinical studies.Manage budgets and forecast financial outcomes.Lead cross-functional teams...

  • Study Site Engagement Lead

    5 months ago

    Sydney, Australia Takeda Pharmaceutical Full time

    Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a** Study Site Engagement Lead **in our Sydney Head Office reporting to the Head of Regional Study Site Engagement Team Lead. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a...

  • Senior Clinical Study Coordinator

    1 month ago

    Sydney, New South Wales, Australia On Q Recruitment Full time

    Senior Clinical Study Coordinator OpportunityWe are seeking a highly skilled and experienced Senior Clinical Study Coordinator to join our team at On Q Recruitment. This is a fantastic opportunity to take on a senior role in managing complex clinical trials, leveraging your expertise to address challenges and drive continuous development through mentoring...

  • Pharmacokinetics Expert

    2 weeks ago

    Sydney, New South Wales, Australia Avance Clinical Pty Full time

    Company OverviewAustralian-based Avance Clinical Pty is a leading Contract Research Organisation offering specialised services in drug development for the pharmaceutical and biotechnology industry. With a rich history dating back to the 1980s, we are experts in our field and have a strong sense of team.SalaryThe estimated annual salary for this position is...

  • Research Development Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    OverviewThe Healthcare Professionals Group is seeking a Research Development Specialist to design and execute clinical studies on medical technologies.About the RoleThis is an exciting opportunity for a skilled professional to play a key role in our expanding Clinical Research team. As a Research Development Specialist, you will be responsible for developing...

  • Clinical Project Manager

    4 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the OpportunityAs a Clinical Trial Manager, you will be responsible for managing local-level trial activities for trials in the Asia Pacific region. Reporting to the Clinical Research Manager, you will lead studies following ICH-GCP guidelines, corporate SOPs, and regulatory requirements.DutiesLead drug development plan input projects and conduct trial...

  • Medical Monitor

    6 months ago

    Sydney, Australia Advanced Clinical Full time

    Medical Monitor (Australia-Wide) **Location**: Sydney NSW, Australia **Requisition Number** **351** **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 by clinical research...

  • Clinical Trials Administrator

    3 weeks ago

    Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full time

    About the RoleAs a leading global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions. We are currently seeking a motivated and organized Clinical Trials Administrator to join our team.Key ResponsibilitiesPrepare study site...

  • Clinical Research Associate

    1 month ago

    Sydney, New South Wales, Australia Abbott Full time

    The OpportunityThis position works for Abbott Medical Australia, a leading medical device company that helps thousands of people worldwide. Our medical devices improve quality of life for people living with chronic pain and movement disorders, and liberate people with diabetes from routine fingersticks.Reporting to the Clinical Operations Manager, this...

  • Area Study Start Up Lead

    3 months ago

    Sydney, Australia AbbVie Full time

    **Company Description** **Job Description** Purpose Statement**: The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single...

  • Area Study Start Up Lead

    2 months ago

    Sydney, Australia AbbVie Full time

    **Company Description** Purpose: The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the...

  • Clinical Trials Project Manager

    1 week ago

    Sydney, New South Wales, Australia Avance Clinical Pty Full time

    At Avance Clinical Pty, we're looking for a highly skilled and experienced Clinical Trials Project Manager to join our team.We offer a stimulating work environment, an intellectual challenge, and the opportunity to progress in your career. Our agile and flexible workplace allows you to work effectively in a fast-paced CRO.ResponsibilitiesManage clinical...

  • Clinical Development Manager

    3 weeks ago

    Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full time

    Clinical Team Lead - SydneyAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, SYD Fortrea Australia Pty Ltd provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more...