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Regional Clinical Trial Management Associate - Roma, Italia - BeiGene, Ltd.
Descrizione
Regional Clinical Trial Management Associate page is loaded Regional Clinical Trial Management Associate Apply locations Italy Remote time type Full time posted on Posted Yesterday job requisition id R22857 BeiGene 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.
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
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
Essential Functions of the job:
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.
Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelinesSupports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, ..)
Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globally
As required, supports CRAs with various activities such as monitoring visit preparations, TMF filing,
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, ..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 (eg, 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
Supervisory Responsibilities:
N/A
Competencies:
Embracing Change
Communicating Effectively
Working in Teams
Learning
Education Required:
Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred
*exceptions might be made for candidates with relevant clinical operations experience
Computer Skills:
MS Office
Other Qualifications:
Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
1 or more years of experience in clinical research within biotech, pharma or CRO industry
Travel:
Limited travel might be required
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters TeamworkProvides 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 and we value diversity.
BeiGene 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.
About Us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
We are committed to radically improving access to medicines for far more patients who need them.Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S.
To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter).To Mainland China Candidates For more information, please visit the link to explore job opportunities in China Mainland.
At BeiGene, how we work is just as important as the work we do . Below are our Values that determine the decisions we make and how we do things.
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