Senior Regional Clinical Study Manager

2 semanas atrás


São Paulo, São Paulo, Brasil BeOne Medicines Tempo inteiro US$90.000 - US$120.000 por ano

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

PLEASE SUBMIT ALL RESUMES/CV'S IN
ENGLISH
FOR CONSIDERATION
Language Requirement
: Portuguese and English required. Spanish preferred.
Preferred Experience
: Pharmaceutical/Biotech Industry, Hematology, Oncology
General Description

  • Accountable for regional study delivery with appropriate inspection readiness quality within agreed timelines and budget
  • Acts as regional lead for multiple studies across an indication or across a program as required
  • Leads the regional clinical operations team (including external partners working on a regional level) and acts as the point of escalation for the resolution of issues within the region for the assigned study
  • Ensures alignment of regional deliverables with overall study goals
  • Contributes to the development of regional tools and leads to the development of work instructions and SOPs as required

Essential Functions
Regional Leadership:

  • Leads the regional clinical operations team effectively, ensures effective decision-making making and acts as a point of escalation for the 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
  • Displays therapeutic area knowledge and expertise

Timelines, Planning And Execution

  • Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for the 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 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 stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs
  • Accountable for submissions of study in countries in assigned regions 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 regularly 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 the 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 the Global Clinical Study Manager and Medical Writing

Quality

  • Handles escalated issues or problems with the sites in the region in close collaboration with stakeholders such as country heads
  • Monitors study activities in the region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations
  • Ensures inspection readiness for study in the region at any point in time throughout the study life cycle
  • Informs Global Clinical Study Manager of any issues arising from the study, evaluates the 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 other colleagues to ensure cross-team, site learnings, and best practices are shared
  • Leads improvements and partners with CST members to enhance efficiency and the quality of the work performed on assigned studies
  • Leads the 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 resource needs and establishes contingency plans for key resources
  • Monitors regional resource utilization over the study life cycle and liaises with functional managers as needed

Minimum Requirements – Education And Experience

  • Bachelor's degree or higher in a scientific or healthcare discipline preferred with a minimum of 7 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
  • A minimum of 1-3 years of relevant clinical operations experience.

Other Experience

  • Proven experience in clinical research including relevant experience as team lead in clinical functions
  • Experience as CRA is preferred

Supervisory Responsibilities

  • Provides performance feedback on team members as required
  • Mentors junior team members and might take online management responsibilities as required

As Required, Line Management Responsibilities

  • Acts as line manager for study start-up and trial monitoring staff (incl SSUS, CRAs).
  • Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development of direct reports.
  • Participate in selection for hiring and allocation of resources to clinical research project.
  • Conducts performance appraisals and supports the establishment of development plans for direct reports, including providing feedback.

Travel: Travel might be required as per business need

Computer Skills
:
Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.



  • São Paulo, São Paulo, Brasil BeiGene Tempo inteiro

    PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATIONLanguage Requirement: Fluent English and Portuguese. Spanish is a plus.Preferred Experience: Pharmaceutical/Biotech Industry- _General Description:- Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget- Acts as regional lead for...


  • São Paulo, São Paulo, Brasil BeOne Medicines Tempo inteiro R$90.000 - R$120.000 por ano

    BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.PLEASE SUBMIT ALL RESUMES/CV'S INENGLISHFOR...


  • São Paulo, São Paulo, Brasil BeOne Medicines Tempo inteiro R$60.000 - R$120.000 por ano

    BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR...


  • São Paulo, São Paulo, Brasil BeOne Medicines Tempo inteiro R$60.000 - R$80.000 por ano

    BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.PLEASE SUBMIT ALL RESUMES/CV'S INENGLISHFOR...

  • Clinical Trial Manager

    1 semana atrás


    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro R$90.000 - R$120.000 por ano

    Clinical Trial Manager – Sponsor Dedicated.Clinical Project Management services provide management of a clinical trial (s) in a regional level. Services/deliverables include operational oversight of assigned project(s) at the regional level for end-to-end project management from start-up through to closeout activities.Tasks & Responsibilities: • Services...


  • São Paulo, São Paulo, Brasil IQVIA LLC Tempo inteiro

    Project Manager, Study Operations, Cronos page is loaded## Project Manager, Study Operations, Cronoslocations: Mexico City, Mexico: Buenos Aires, Argentina: São Paulo, Braziltime type: Full timeposted on: Posted 8 Days Agojob requisition id: R1503492Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to...


  • São Paulo, São Paulo, Brasil IQVIA LLC Tempo inteiro

    Project Manager, Study Operations, Cronos page is loaded## Project Manager, Study Operations, Cronoslocations: Mexico City, Mexico: Buenos Aires, Argentina: São Paulo, Braziltime type: Full timeposted on: Posted 8 Days Agojob requisition id: R Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve...


  • São Paulo, São Paulo, Brasil Alimentiv Tempo inteiro R$120.000 - R$240.000 por ano

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Regional Project Lead

    Há 20 horas


    São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro R$120.000 - R$240.000 por ano

    Company Description PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description The Regional Project Lead manages and coordinates...


  • São Paulo, São Paulo, Brasil CTI Clinical Trial and Consulting Tempo inteiro R$120.000 - R$240.000 por ano

    Principal Clinical Research AssociatePlease submit your CV in English for Quickest Review ProcessMaintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that...