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Senior Regional Clinical Trial Management Associate
BeOne Medicines. Support the Regional Clinical Study Manager in regional study delivery and delegated clinical study components .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial operations, supporting regional study delivery, vendor management, and compliance with regulatory requirements. Proficient in managing clinical study documentation and facilitating effective communication among stakeholders.
Highest-signal resume keywords
Clinical Research ExperienceKnowledge Of Clinical Operations MethodologiesMS Office ProficiencyETMF ProficiencyCTMS Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial OperationsFeasibility AssessmentDocument GenerationParticipant EnrollmentMonitoring Visit PreparationRegulatory SubmissionsData CleaningQuality Assurance AuditsProcess ImprovementsSOP Development
Soft Skills
MentoringCollaborationCommunication
Tools & Technologies
SharePointETMFCTMS
Industry Keywords
BiotechPharmaCROClinical Study ManagementOperational Risk Identification
About the role
Key responsibilities & impact- Support the Regional Clinical Study Manager in regional study delivery and delegated clinical study components
- Support Clinical Research Associates and/or Study Start-up Specialists in country study delivery
- Apply knowledge of clinical trial operations and support alignment of regional deliverables with overall study goals
- Support regional vendor management and other regional study management activities
- Participate in internal working groups and initiatives
- Serve as a subject matter expert in a specific process and potentially mentor team members
- Support feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment
- Support CTMS updates, ISF binder preparation, document collection, ICF customization, and eTMF maintenance
- Support monitoring visit preparation, equipment management, contract activities, regulatory submissions, TMF filing, and SUSAR submissions
- Create and maintain SharePoint folders, distribution lists, and country/site records in eTMF and CTMS
- Support system access and user account management throughout the study lifecycle
- Support local adaptation and review of study-related documents
- Support investigator meetings, TMF creation and quality control, clinical supplies issues, data cleaning, site communications, and routine site questions
- Support public registry information maintenance and Clinical Study Report input
- Support operational risk identification, quality assurance audits and inspections, process improvements, tools, work instructions, and SOPs
- Support vendor selection, regional study budgets, purchase orders, payments follow-up, and accrual activities
Requirements
What you’ll need- Preferably bachelor's degree, preferably in a scientific or healthcare discipline required; higher degree preferred
- Exceptions might be made for candidates with relevant clinical operations experience
- 2 or more years of experience in clinical research within biotech, pharma or CRO industry
- Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes
- MS Office, eTMF, CTMS proficiency
- Limited travel might be required
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits