Department: Global Clinical Development Operations
Reports To: Sarah Merolle, AD IRT Systems
Bachelor or Master Degree in Computer Science, Business Administration, Operations Management, or similar education required.
3-5 years progressive experience in IRT validation
The primary responsibility of the Manager, IRT Validation is to manage BeiGene’s companywide Interactive Response Technology (IRT) processes related to User Acceptance Testing. Responsible for identifying UAT requirements to ensure proper risk mitigation to ensure system is properly qualified for use. Leads UAT activities effectively and coordinates with team members across BeiGene sites and functions to support UAT. Supports UAT related activities and acts as point of internal escalation to assist and closure of UAT issues with vendors. Has strong cross-cultural awareness and communication skills to work in fast paced multi-cultural company
- Deciphers IRT study specific requirements to ensure proper risk mitigation while developing test plans.
- Authors test scripts to ensure documented evidence is generated to prove that the system performs as intended.
- Lead UAT by defining, developing and implementing practices and procedures for complete end user test plans.
- Provides training and support to team members to ensure successful execution of test scripts.
- Participates in the tracking and management of open issues and raises ongoing issues.
- Responsible for overall success of user acceptance testing, including results verification and release approvals.
- Ensures all user acceptance tests are documented according to standards.
- Understands industry issues faced in sponsor driven IRT UAT efforts and supports several moderately complex business processes.
- Gathers information about current work processes and information flows and documents existing business process to define new enhancements to gain better efficiency in the testing process.
- Has strong knowledge of testing processes, methodologies and tools
- Communicates effectively via email and conference calls as needed.
- Provide guidance to Global Development Operations (GDO) management team and cross functional teams on IRT best practices and trends.
- Ensure systems and documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, Annex 13 as well as in accordance BeiGene SOPs and processes
- Additional responsibilities as required.
- Demonstrates knowledge of global clinical trials and the drug development process.
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. ICH/GDP, GCP, 21 CFR Part 11, and Annex 13).
- Experience in development IRT system plans and specifications.
- Working knowledge of EDC.
- Ability to work effectively in cross-functional and multi-cultural teams.
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.
Computer Skills: Proficient in Microsoft Office applications, EDC, IRT systems
Other Qualifications: Due to global nature of company early morning or evening meeting may be required
BeiGene USA, Inc. is an Equal Opportunity Employer welcoming diversity in our workforce. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring, and promotion practices are performed without regard to the above-listed items.