Regional Clinical Trial Management Senior Associate

BeOne Medicines Ltd.; United States; On-site; USD 84,000 - 114,000; Full time

Benefits offered by this job

Medical benefits

401(k)

PTO & Wellness

Job summary

BeOne Medicines Ltd. is seeking an experienced clinical study support professional in the United States. You will assist in regional study delivery, start-up activities, document management and TMF maintenance, working with CRAs and SSUSs to ensure quality and timelines.

Strong knowledge of clinical operations and regulatory guidelines is essential. The role requires 2+ years in clinical research, a bachelor’s degree in a scientific or healthcare field, and proficiency with MS Office, eTMF and

Qualifications

• 2+ years of clinical research experience in biotech, pharma or CRO
• Bachelor's degree in a scientific or healthcare discipline is required
• Knowledge of ICH guidelines and regulatory expectations

Responsibilities

• Support Regional Clinical Study Manager in country and regional study delivery
• Assist CRAs and SSUSs with study start-up, CTMS updates and document management
• Coordinate study-related activities, meetings and documentation across regions
• Maintain TMF quality through file creation, filing and QC checks
• Assist with vendor management, budgets, and payments follow-up

Skills

Clinical operations experience

Education

Bachelor-level degree in science/healthcare

Tools

MS Office

eTMF

CTMS

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

Regional Trial Support & Collaboration

• 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. aus>
• Might support the maintenance of info for region/country in public registries (e.g., CT.gov).
• Supports the Regional Clinical Study Manager by providing all relevant info 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 quality of the work performed on assigned projects.
• Supports the development of local/regional tools, working instructions, and SOPs.

Budget

• Supports selection and set up of vendors for activities outsourced in region/country.
• Supports management of regional study budget incl PO set up.
• Supports management of regional vendors incl PO set up.
• Supports with payments follow up (sites, stakeholders).
• Might assist with accrual activities if required.

Supervisory Responsibilities

• Might mentor other team members.

Computer Skills

• MS Office, eTMF, CTMS

Other Qualifications

• Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
• 2 or more years of experience in clinical research within biotech, pharma or CRO industry

Travel

• Limited travel might be required

Education Required

Preferably bachelor's degree with 2+ years experience, preferably in a scientific or healthcare discipline required*, Higher Degree preferred

• Exceptions might be made for candidates with relevant clinical operations experience

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

Salary Range: $83,800.00 - $113,800.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].