Regional Clinical Trial Management Senior Associate

BeOne Medicines USA; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

BeOne Medicines USA is seeking a Regional Clinical Study Support professional to assist the Regional Clinical Study Manager in delivering studies across the region, ensuring quality, timelines, and budget adherence. The role collaborates with CRAs and Study Start-up Specialists to align country and regional activities with global study goals.

You will contribute to CTMS/eTMF processes, support study start-up, document management, and regulatory submissions while maintaining strong stakeholder

Responsibilities

• Supports the Regional Clinical Study Manager in regional study delivery.
• Assists country study management activities including CTMS updates and document collection.
• Maintains regional and country level TMF, filing, reconciliation and QC as per plan.
• Engages with stakeholders regionally and globally to ensure alignment with study goals.

Job description

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.

General Description

• Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed to 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.
• Applies 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.
• Supports regional vendor management in addition to other regional study management activities.
• Participates in internal working groups and initiatives.
• Provides knowledge and expertise in a specific process as a subject matter expert (SME).
• Might mentor other team members.
• Performs other tasks assigned by the line manager.

Essential Functions of the Job

• Acquires regional study management experience by supporting 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 country study management experience by supporting CRAs and/or 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.
• Knowledgeable 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 regional 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, support 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 ensures 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 the 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 resolve 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., CT.gov).
• Supports the Regional Clinical Study Manager by provid