GTS MANAGER, CLINICAL SYSTEMS

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:

 

The GTS (Global Technology Solutions) Manager of Clinical Systems is responsible for design, development, implementation, and administration of critical Clinical Business Systems for the Global Clinical Operations (GCO) organization. The role will work closely with the GCO team, to define and document functional and technical requirements for both validated/non-validated Clinical Systems, system integrations, dashboards/reports, as well as identify and implement solutions to address areas of improvement within systems. This role will also be responsible for operational support of Clinical Systems and requires hands-on experience building and/or configuring systems and requires close collaboration with teams of GTS technical application owners, network/security engineers, and GTS infrastructure.

 

The ideal candidate should bring experience working in GxP environment with the ability to manage multiple projects across different functions for a global, geographically diverse environment.  The candidate should also be experienced at supporting GTS projects from a business analysis, technology, security, process, and people management standpoint.

 

Essential Functions of the job:

• Act as technical and/or project lead in the planning, design, configuration, testing and deployment of new systems and enhancements to existing computerized systems primarily for the Global Clinical Operations team.
• Ensure the overall health and stability of deployed applications and coordinate resolution when issues arise.
• Deliver on multiple projects and tasks independently, quickly learn new technologies and systems, and think critically about system impact to GCO business processes and global end user adoption.

 

Strategy & Planning

• Collaborate with GTS Infrastructure Engineering, Validation Engineers, Operations, Security/Compliance, QA, Service Desk, and applicable vendor teams to properly assess system complexity, compliance requirements and technical requirements.
• Partner with stakeholders in the design, configuration, and data integration between multiple systems along with future strategy towards an integrated clinical platform
• Solution systems for the purpose of enhancing business processes, operations, and information flow across the Clinical Operations organization. Provide solution options to all levels of management with the ability to recommend industry and best practices and implement accordingly. 

 

Implementation and Delivery

• Collaborate with project teams in the planning, design, configuration, and deployment of new applications, and enhancements to existing applications and platforms.
• Represent GTS as the application owner and/or technical lead for projects and enhancements from initiation through implementation and support.
• Facilitate technical support during application implementation, upgrades, and migrations.
• Liaise with computer system vendors, GTS partners, Quality, Validation, and the business to coordinate implementation activities.
• Partner with GTS Help Desk and GTS Operations to develop post-implementation support structure.
• Author system process documents such as SOPs/Work Instructions, User Access forms, runbooks
• Gather and document end user requirements and translate to technical requirements.
• Support multiple projects and manage tasks independently, quickly learn new technologies and systems, and think critically about global business processes and global end user adoption.
• Manage consultants/vendors to ensure projects and/or required system administration activities are addressed adequately.

 

Operational Management

• Adhere to global GTS security policies and follow proper GTS Change Control processes, including remediation of systems that are out of compliance to GTS policies and best practices.
• Oversee change management for existing systems adhering to GxP processes.
• Support GxP activities on existing systems including user access review, periodic review, etc
• Monitor/triage help desk tickets and escalations as related to Clinical Systems.
• Support audit and inspection requests.
• Provide administration support, manage access and security, and provide recommendations for reported issues/enhancement requests from end-users. Occasionally provide end user training. Test any fixes and perform post-resolution follow-ups to ensure issues have been adequately addressed.
• Work with software vendors to understand existing and future release functionality including execution of protocols, perform testing sequences and change controls.

 

Supervisory Responsibilities:  

• This position may include managing vendors, contractors. This position may also include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required. 

 

Qualifications

• 5+ years of Biotech/Pharmaceutical industry experience with comprehensive management of clinical technologies and platforms (i.e., eTMF, PowerBI Clinical Trial Management Systems (CTMS), Risk Based Quality Management System (RBQM), Clinical Trial Registration Systems, etc.)
• Direct experience operating in a business/technical analyst role with a proven record of business analysis including development of requirements and mapping requirements to data/technical solutions.
• Direct hands-on experience supporting and administering GxP computerized systems within an SDLC framework.
• Proven experience in overseeing the direction, planning, installation, implementation, validation, and maintenance of software solutions.

 

Other Qualifications:

• Excellent project management skills and/or substantial exposure to project-based work structures.
• Ability to communicate ideas in both technical and user-friendly language.
• Ability to effectively prioritize and execute tasks in a team-oriented, collaborative environment.
• Strong knowledge of authoring computer system validation documentation, SOPs/Wis and runbooks
• Ability to take independent action, working with a high-level problem or concept, developing the right next steps to propose resolution and ensuring successful outcome.  
• Balance creativity and innovation against practical /cost effective approaches.
• Strong process improvement skills and orientation
• Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills. Strong commitment to customer service and proactively follows up with end users.

 

Education Required:

Four-year college diploma or university degree in Life Science, Computer Science, Information Systems or equivalent experience.

 

Travel:  <; 5%

 

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.

 

 

Salary Range: $118,500.00 - $158,500.00 annually

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.