Regional Clinical Trial Management Associate
Há 4 dias
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
: Fluent English and Spanish is a differentiator
Preferred Experience
: Pharmaceutical/Biotech Industry, Hematology, Oncology
General Description
- Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budget.
- Supports the Clinical Research Associates and/or Study Start-up Specialists in country study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards.
- Builds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager.
- Supports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager.
- Might participate in internal working groups, initiatives.
- Performs other tasks assigned by the line manager.
Essential Functions
Regional Trial Support & Collaboration
- Develops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.
- Develops country study management experience by supporting CRAs and SSUSs with multiple aspects of clinical trial conduct including CTMS updates, ISF binder preparation, document collections,
- ICF customization, eTMF maintenance (document filing, reconciliation and review at site level or country level.
- Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines.
- Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, etc.).
- Supports the Country Heads with set up and logistics of country team meetings (agenda, minutes etc.).
- Establishes good collaboration with key stakeholders regionally, globally and at country level (Regional Clinical Study Manager, Regional Clinical Trial Management Associate, Global Study Management Associate, Clinical Research Associates and Study Start-up Specialists).
- As required, supports CRAs with various activities such as monitoring visit preparations, equipment management, Contract support, EC/regulatory submission preparation/tracking, TMF filing, SUSAR submission, etc.
Timelines, Planning and Execution
- Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.
- Sets up the countries and sites in the region in the appropriate systems e.g., eTMF, CTMS, etc. and makes sure information is kept up to date.
- Supports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region.
- Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager.
- May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters).
- Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager.
- Supports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate.
- Supports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan.
- Helps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholders.
- Supports the data cleaning activities and contributes to the follow up of outstanding information for region/country.
- Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team.
- Might assist in resolution of routine study questions from clinical trial sites.
- Might support the maintenance of information for region/country in relevant public registries (e.g., ).
- Supports the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study Report.
Quality
- Supports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.
- Learns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and compliance.
- Might support the preparation of sites for quality assurance audits and inspections.
- Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects.
- Might support the development of local/regional tools, working instructions and SOPs.
Budget
- Supports set up of vendors for activities outsourced in region/country.
- Supports management of regional study budget incl PO set up.
- Supports PO set up for regional vendors.
- Supports with payments follow up (sites, stakeholders).
- Might assist accrual activities, if required.
Minimum Requirements – Education And Experience
- Bachelor's Degree, preferably in a scientific or healthcare discipline required
- Higher Degree preferred
- 1 or more years of experience in clinical research within biotech, pharma or CRO industry.
- Fluency in English
- Spanish is a differentiator
Other Experience
- Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes.
Supervisory Responsibilities: N/A
Travel: Limited travel might be required
Computer Skills
:
MS Office, eTMF, CTMS
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 BeOne Medicines Tempo inteiro R$60.000 - R$120.000 por anoBeOne 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...
-
Clinical Trial Manager
Há 4 dias
São Paulo, São Paulo, Brasil IQVIA Tempo inteiro R$90.000 - R$120.000 por anoClinical 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...
-
Clinical Trials Assistant I
3 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiro**Clinical Trials Assistant I****Hybrid Role - Location: São Paulo, Brazil****Job Overview**Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.**Essential Functions**- Assist Clinical Research Associates (CRAs) and...
-
Clinical Trials Assistant
3 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroOverview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...
-
Clinical Trials Assistant
3 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroOverviewClinical Trials Assistant - Exclusive for PWD role at IQVIA. This talent pool is for people with disabilities. If you do not belong to this group, you can apply for other vacancies within IQVIA jobs.Job overviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a...
-
Clinical Trials Assistant
3 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroOverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential FunctionsAssist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents...
-
Clinical Trials Assistant
Há 2 dias
São Paulo, São Paulo, Brasil IQVIA Tempo inteiro R$30.000 - R$60.000 por anoThis is a talent pool for people with disabilities. If you do not belong to this group and wish to apply, you can apply for other vacancies within IQVIA jobs.Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File...
-
Clinical Trials Assistant
3 semanas atrás
São Paulo, São Paulo, Brasil IQVIA LLC Tempo inteiroClinical Trials Assistant - Exclusive for PWD page is loaded## Clinical Trials Assistant - Exclusive for PWDlocations: São Paulo, Braziltime type: Full timeposted on: Posted Yesterdayjob requisition id: R1505015# *This is a talent pool for people with disabilities. If you do not belong to this group and wish to apply, you can apply for other...
-
Clinical Trials Assistant I
Há 4 dias
São Paulo, São Paulo, Brasil IQVIA Tempo inteiro R$120.000 - R$180.000 por anoClinical Trials Assistant IHybrid Role - Location: São Paulo, BrazilJob OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions• Assist Clinical Research Associates (CRAs) and Regulatory and...
-
Clinical Trials Assistant I
3 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroOverviewClinical Trials Assistant I – Hybrid Role - Location: São Paulo, BrazilJob Overview: Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.ResponsibilitiesAssist Clinical Research Associates (CRAs) and Regulatory...