Senior Study Start-Up Specialist

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:

• Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.

Essential Functions of the job:

• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
• Site Feasibility
  • Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key information to support with site identification and selection; Liaise with internal stakeholders (i.e., CRAs, FMDs, CSMs) as needed.
  • Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.
• Site Start-Up
  • Skilled in driving kick-off and completion of tasks from selection through activation.
  • Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
• ICF/Submissions
  • Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
  • Skilled in document preparation and submission to central IRB to ensure timely reviews.
• Ensure collection and review of essential documents
• Complete SSU data entry in CTMS
• Support in the development of local workflows to streamline output and deliverables
• Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America
• Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals

Computer Skills:   Intermediate skils in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

Other Qualifications:   

• Knowledge in the execution of clinical trials, understanding of ICH/GCP
• Effective prioritization of tasks in the achievement of goals
• Strong written and verbal communication skills
• Highly organized
• Diligence in follow through

Travel:  Up to 10%

Education Required:

Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans 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 analyzes information skillfully.

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

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

BeiGene 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 BeiGene 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 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.