Regional Clinical Trial Management Senior Associate

BeiGene

14d • $83,800 - $113,800

About The Position

BeOne is seeking a highly motivated, collaborative professional who shares its interest in fighting cancer. The Regional Clinical Trial Management Senior Associate supports the Regional Clinical Study Manager in regional study delivery and supports Clinical Research Associates (CRAs) and/or Study Start-up Specialists (SSUSs) in country study delivery. The role ensures delegated clinical study activities are completed to specified quality standards, timelines, and budgets, applying clinical trial operations knowledge under the guidance of the Regional Clinical Study Manager. The associate also supports regional vendor management, aligns regional deliverables with study goals, participates in working groups and initiatives, and may serve as a subject matter expert or mentor other team members.

The role supports regional and country trial activities throughout study conduct, including feasibility, study start-up, document preparation and review, sample and enrollment tracking, CTMS updates, ISF preparation, document collection, informed consent customization, and eTMF maintenance. It helps maintain study systems and records, coordinates meetings and investigator activities, supports regulatory and ethics submissions, assists with data cleaning and issue resolution, and contributes regional and country information for Clinical Study Reports. The associate also supports operational risk identification, quality and compliance activities, vendor selection and management, budget administration, purchase orders, and payment follow-up.

The position requires knowledge of clinical operations and at least two years of clinical research experience in the biotech, pharmaceutical, or CRO industry. A bachelor's degree is preferred, particularly in a scientific or healthcare discipline; a higher degree is preferred. Exceptions may be considered for candidates with relevant clinical operations experience. Limited travel may be required. The listed annual base salary range is $83,800 to $113,800. Eligible employees may participate in applicable annual bonus or incentive plans and may receive discretionary equity awards or participate voluntarily in the Employee Stock Purchase Plan. The company also describes a comprehensive benefits package.

Requirements

• At least 2 years of clinical research experience in the biotech, pharmaceutical, or CRO industry.
• Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes.
• Knowledge of clinical research operations, including interpretation and implementation of regulations and ICH guidelines.
• Proficiency with MS Office, eTMF, and CTMS.
• A bachelor's degree is preferred, preferably in a scientific or healthcare discipline; relevant clinical operations experience may be considered in place of the stated education preference.

Nice To Haves

• A higher degree is preferred.
• Experience or knowledge that enables contribution as a subject matter expert in a specific process.
• Experience mentoring other team members.

Responsibilities

• Support the Regional Clinical Study Manager in regional study delivery and execution of delegated study components to quality, timeline, and budget expectations.
• Support CRAs and/or SSUSs with country-level clinical study delivery, including CTMS updates, ISF binder preparation, document collection, ICF customization, and eTMF maintenance.
• Support clinical trial conduct activities such as feasibility assessment, study start-up, document generation and review, and tracking samples and participant enrollment.
• Apply knowledge of clinical research operations, including interpretation and implementation of regulations and ICH guidelines.
• Support setup and logistics for regional team meetings, including agendas and minutes, and establish collaboration with regional, global, and country stakeholders.
• Support CRAs with activities such as monitoring visit preparation, equipment management, contract support, ethics committee and regulatory submission preparation and tracking, TMF filing, and SUSAR submissions, as required.
• Create and maintain regional and country SharePoint folders and study-team distribution lists.
• Set up countries and sites in systems such as eTMF and CTMS, keep information current, and support system-access requests and user-account management throughout the study life cycle.
• Support local adaptation of global documents and review of study-related documents as delegated by the Regional Clinical Study Manager.
• Support regional and country study start-up in collaboration with the regional study start-up team and Regional Clinical Study Manager.
• Help organize study-specific investigator meetings with the Regional Clinical Study Manager and Global Study Management Associate.
• Support the TMF specialist with country- and site-level TMF creation, maintenance, document review, and quality control according to the study TMF QC plan.
• Help resolve regional or country clinical-supply issues in collaboration with relevant stakeholders.
• Support data-cleaning activities and follow up on outstanding regional and country information.
• Prepare site newsletters and other clinical-trial correspondence in collaboration with the study team.
• Assist with routine clinical-site questions and maintain regional or country information in public registries such as ClinicalTrials.gov, as applicable.
• Provide regional and country information for inclusion in the Clinical Study Report.
• Support identification of operational risks and work with the Regional Clinical Study Manager to recommend solutions for leadership discussion.
• Learn and share clinical operations best practices, methodologies, systems, and processes, emphasizing quality and compliance.
• Potentially support site preparation for quality assurance audits and inspections; suggest improvements and support development of local or regional tools, work instructions, and SOPs.
• Support selection and setup of regional or country vendors, regional study budget management, purchase orders, vendor management, payment follow-up, and accrual activities as required.
• Participate in internal working groups and initiatives, provide subject-matter expertise in a specific process, and potentially mentor team members.
• Perform other tasks assigned by the line manager.

Benefits

• Medical, dental, and vision coverage.
• 401(k).
• FSA/HSA.
• Life insurance.
• Paid time off.
• Wellness benefits.
• Eligible non-commercial roles may participate in an annual bonus plan; commercial roles may participate in an incentive compensation plan.
• Employees are eligible for discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior