Junior/Senior Clinical Trial Associate

Job content

BeiGene 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

• Role will support the study team with Clinical Operations tasks, and/or support compilation and quality of the trial master file (TMF)
• Demonstrates basic clinical operations knowledge and strong organizational skills
• Implements best practices and shares lessons learned with team and other colleagues, as appropriate
• Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
• The Junior Associate role in Clinical Operations is an entry level position
  
  

Clinical Operations Support To Study Teams

This job description provides the broadest description of potential assigned activities. There will be specific roles and responsibilities assigned from this Job Description, according to project assignment(s). As such, responsibilities willinclude some of the following activities, but may not be limited to:

Support Cross-functional Clinical Study Teams From Start-up Through Close-out

• Assists in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking)
• Preparation and documentation of internal and external meetings by preparing agendas and minutes
• Maintaining clinical operations tracking tools e.g.
• enrollment
• CTMS
• laboratory samples
• monitoring visits
• site status
• support in HA and IRB/EC submissions; support study team with site start-up preparation, EC fee application and tracking
• drug supply
• data cleaning
• vendor tracking
• training
• risk management
• study goals
• investigator contracts and payments; support study team with site level payments and invoices
• invoice reconciliation and budget tracking
• Support reporting for Senior Management updates
• Clinicaltrials.gov and/or local registry posting and maintenance
• Site materials and equipment: support study team with distribution of site materials and equipment, document printing, shipment, and other administrative work
• Administrative: business and department office administration support if required
  

Trial Master File (TMF)

• Preparation of TMF Plan and/or map
• Setup, maintenance and close out of TMF; coordinate on document collection, uploading into SharePoint (SP)/eTMF
• Ensure completeness and quality of TMF content for assigned clinical trials consistent with TMF specifications/plan, applicable SOPs, ICH/GCP guidelines and regulatory requirements; provide TMF/eTMF quality control (QC) if required
• Ensure the TMF is submission/inspection ready
• Be the primary point of contact for the TMF-related questions or issues
• Develop successful cross-functional relationships with internal and external TMF stakeholders
• Oversee documentation flow within projected timelines and determine course of action needed to prevent and remediate delays and errors with TMF compilation
• Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses
• Effectively monitor and report on progress of the TMF to stakeholders
• Apply lessons learned to continuous improvement of documentation management practices across study teams
• Provide education, feedback and guide study teams to build knowledge and awareness of good document management practices for clinical trials
• Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with study lead or equivalent if modifications are necessary
• Guide Study Team in the effective management of TMF when working with external vendors
  
  

Mentoring Responsibilities

• More senior members of the associate team may mentor junior associates
• Associates with experience in specific tasks may mentor other associates with less or no experience in these tasks
  

Project Management - Communicates changes and progress; Completes projects on time and budget.

Education Required

• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 2 years of experience in clinical operations (Senior Associate).
• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 1 year of experience in clinical operations (Associate).
• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* (Junior Associate). Entry level.
• exceptions may be made on case-by-case basis where candidates demonstrate appropriate skill set for a role in Clinical Operations and awareness of the role.
  

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications

• Ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization
  

Travel: up to15%

Competencies

Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and to high ethical standards; Uphold organizational values.

Planning/Organizing - Able to prioritize and plan work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyses information skillfully.

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.