Job Description

**General** **Description:**

As directed by the Head of Global IRT Systems, the primary responsibility of the Manager, IRT Systems is to lead BeiGenes global Clinical Study Teams (CSTs) effectively and efficiently, in Interactive Response Technology (IRT) implementations, including its setup, maintenance, and closeout. This includes (but is not limited to):

+ Leading CSTs in designing/specifying IRTs, including any integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters, and with a high degree of usability.

+ Leading CSTs in risk-based scoping, and execution of Sponsor UATs, so that IRTs and any associated integrations are adequately tested to ensure the systems perform acceptably for intended use.

+ Supporting day-to-day activities to resolve IRT-related items with IRT vendors, primarily from (but not limited to) system updates driven by protocol amendments, optimizing design, and fixing system bugs.

+ Applying appropriate risk identification, assessment, and mitigation practices, to ensure acceptable levels of IRT performance during the conduct of clinical trials.

+ Ensuring appropriate levels of documentation are created, revised, and archived for IRTs and any associated integrations, to support audits of clinical trials.

Throughout, the Global IRT Systems Manager is expected to observe and promote a high standard of quality, as expected of work performed in this regulated field. Leveraging on experience, the Manager is further expected to identify and act on opportunities for continuous improvement, to increase quality and efficiency of BeiGene processes and systems. The Global IRT Systems Manager should have strong cross-cultural awareness and communication skills to work in fast paced, multi-cultural company. This is especially important as the Manager may instruct, mentor, and oversee junior members of the team.

**Responsibilities:**

+ Leads IRT builds, enhancements, and study operations to ensure compliance with protocol requirements and BeiGene business processes.

+ Identifies, advises, and provides insights to cross-functional teams on IRT best practices and trends.

+ Leads and supports IRT Improvement Initiatives and manages improvement projects that impact daily operations to improve efficiency.

+ Leads and supports BeiGene projects expected to impact the IRT Systems team.

+ Leads and supports the development and implementation of Standard Operation Procedures (SOP) and processes.

+ Leads project management activities related to IRT development, maintenance, and closeout.

+ Participates and collaborates in vendor evaluation, selection, and contracting activities including review of Request for Proposal (RFP) and User Requirements & Vendor Response sheets.

+ Leads User Acceptance Testing (UAT), manages creation of test plan, as well as develops test scripts to ensure proper risk mitigation. Leads improvement opportunities related to UAT across projects/programs to improve efficiency.

+ Ensures effective system access and functionality across all countries and BeiGene user locations.

+ Supports vendor meetings regarding performance, timelines, and issue resolution/escalation and supports Business Review activities

+ Supports the Head of Global IRT Systems with mentoring and training of team members.

+ Ensures systems and documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance with BeiGene SOPs and processes.

+ Additional responsibilities as required and directed by the Head of Global IRT Systems.

**Supervisory Responsibilities** :

+ May supervise junior members of the Global IRT Systems team, Functional Service Providers (FSP) and/or contractors.

**Computer Skills:**

+ Proficient in Microsoft Office applications, EDC, IRT systems

**Qualifications:**

+ Bachelor or Master Degree in Computer Science, Business Administration, Operations Management, or similar education required.

+ 5+ years with progressive experience managing IRT systems

+ Due to global nature of this position, early morning or evening meetings may be required.

**Travel:**

+ Up to 15% (domestic and international)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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