General Description:

• The Senior Systems Analyst role will be responsible for configuration, administration and maintenance of business-critical Clinical IT systems and applications.

• The ideal candidate should bring experience working on multiple projects across different functions for a global, geographically diverse environment.

• The candidate should be experienced implementing Clinical Systems from end-to-end, including supporting/troubleshooting business critical integrations.

• The individual must be able to provide technical expertise and have extensive application administration experience, especially clinical systems with integrations.

• The candidate should have strong understanding of Computer Systems Validation and SDLC methodologies in GxP regulated environment.

• This role requires ensuring the operational activities for the system are in adherence to policies and procedures.

Essential Functions of the job:

• Support the prioritization of projects, changes and operational activities as defined by GTS management.

• To provide clinical trial systems implementation, operational and maintenance support under the guidance of senior staff. Clinical systems mentioned here refer to systems that support clinical operations.

• Collaborate with project team members in the testing and validation of changes and enhancements to the system including:

• Participate in functional requirement gathering and design review meetings.

• Work with the business to develop system requirements.

• Oversee documentation of configuration and design specifications.

• Manage and sometimes execute User Acceptance Test (UAT) scripts.

• Oversee the authoring of computerized system validation documentation.

• Perform regular operational activities in support of help desk tickets specific to systems issues and questions from end users including but not limited to:

• User Account creation/modification

• Integration problem and investigation

• Report analysis and customized report generation

• System bug escalation, etc.

• Synthesizes data, information, and knowledge to clarify system issues or problems.

• Implements processes that streamline reporting within clinical systems.

• Develop support related documents as needed.

• Where applicable, deliver system related IT training to end users and/or form the training process in compliance with GCP.

• Completes other special tasks or projects, as and when assigned, or otherwise requested.

• Consistently complies with all governing laws, regulations, company SOPs and other guidelines.

Education Required:

Bachelor’s degree required

Supervisory Responsibilities:

• N/A

Experience Requirements::

• Prior experience working in the Biotech/Life Sciences or IT Consulting industry, including pharmaceutical, biotechnology or medical device.

• Minimum (4) years direct experience operating in a systems analyst role with a proven record of business analysis including development of requirements and mapping business processes to technical solutions.

• Able to 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.

• End-to-end hands-on experience implementing clinical systems.

• Extensive experience gathering and documenting end user requirements and translating to technical requirements.

• Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills.

• Able to analyze, clearly document and communicate user requirements.

• Hands-on experience administering SaaS/Cloud platforms.

• Able to work in a global IT delivery service model.

• Experience working in a team-oriented, collaborative environment.

• Proven experience operating in regulated environments, with GxP and 21 CFR Part 11.

• Understands software delivery lifecycle and computer systems validation.

Other Qualifications:

• Knowledge and experience of clinical trial processes.

• Previous experience in development, deployment and/or maintenance of clinical systems in the pharmaceutical, biotechnology or related industry is a big plus.

• Knowledge of international regulations, processes and issues in drug development.

• Familiarity of clinical operations processes is an advantage.

• Fluent English and/or other language skills as needed.

• Outstanding attention-to-detail and follow through.

• Comfortable working in a fast-paced, dynamic environment, and adapt to changes in responsibilities and workloads.

• Excellent time management & organizational skills: can prioritize multiple tasks and goals and ensure the timely, on-target accomplishment with precision.

• Good interpersonal, communication skills.

• Works well within teams and is effective in collaborating with others internally and externally.

Travel: <5%

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.