Senior Regional Clinical Trial Management Associate

Senior Regional Clinical Trial Management Associate

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.

Language Requirement: Fluency in English and Spanish (previous experience in other Latin American countries is a differentiator). Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology. Location: This is a hybrid position with a minimum of 1 day per week in office in Sao Paulo.

Overview

The Senior Regional Clinical Trial Management Associate supports regional study delivery and collaborates with cross-functional teams to ensure that delegated components of clinical studies are executed to expected quality standards, within timelines and budget. This role may mentor other team members and often serves as a subject matter expert (SME) in specific processes.

Responsibilities

• Supports the Regional Clinical Study Manager in regional study delivery and ensures delegated components of clinical studies meet quality standards, timelines, and budget.
• Supports country study delivery by assisting Clinical Research Associates and/or Study Start-up Specialists; ensures country-level activities align with study goals.
• Applies knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager.
• Supports regional vendor management and other regional study management activities; participates in internal working groups and initiatives.
• Provides SME input in a specific process and may mentor other team members.
• Performs other tasks as assigned by the line manager.

Essential Functions

• Gains regional study management experience by supporting feasibility assessment, study start-up, document generation and review, tracking of samples, and enrollment of participants.
• Supports country-level activities by assisting with CTMS updates, ISF binder preparation, document collection, ICF customization, and eTMF maintenance.
• Understands regulatory requirements and ICH guidelines; supports regional team meetings (planning and documentation).
• Collaborates with regional and country stakeholders (Regional Clinical Study Manager, Global Study Management Associate, CRAs, SSUSs) to ensure alignment of deliverables.
• Assists CRAs with monitoring preparations, equipment management, regulatory submissions, TMF filing, SUSAR submissions, and related activities as needed.

Timelines, Planning and Execution

• Maintains regional/country study folders and distribution lists; sets up and maintains regional systems (eTMF, CTMS).
• Manages system access requests and user accounts for the region; supports local adaptation of global documents under supervision.
• Supports study start-up in region/country and coordinates investigator meetings with the Regional Clinical Study Manager and Global Study Management Associate.
• Supports TMF operations at country/site level and ensures timely QC of TMF documents; assists with clinical supplies issues and data cleaning activities.
• Prepares site newsletters and correspondence related to trial conduct; may assist with responses to routine site queries.
• Maintains information for region/country in relevant public registries (e.g., ClinicalTrials.gov) as needed; supports inclusion of regional data in the Clinical Study Report.

Quality

• Identifies operational risks and recommends solutions; shares best practices in clinical operations methodologies, systems, and processes with emphasis on quality and compliance.
• Supports preparation of sites for QA audits and inspections; suggests improvements to efficiency and quality of work.
• Supports development of local/regional tools, working instructions, and SOPs.

Budget

• Supports vendor selection and setup for regional activities; assists with regional study budget management and PO setup.
• Supports vendor management and payments follow-up; may assist with accrual activities if required.

Minimum Requirements – Education And Experience

• Bachelor’s Degree, preferably in a scientific or healthcare discipline; higher degree preferred.
• 2+ years of experience in clinical research within biotech, pharma, or CRO industry.
• Fluency in English and Spanish (experience in other Latin American countries is a differentiator).

Other Experience

• Knowledge of clinical operations methodologies and the operational aspects of clinical study processes.

Supervisory Responsibilities: Might mentor other team members. Travel: Limited travel may be required. Computer Skills: MS Office, eTMF, CTMS.

Global Competencies

• 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.

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