- Hands-on support of clinical systems and other KalVista applications such as data capture (EDC/ePro), randomisation and drug supply (IRT), eTMF and analytics & reporting
- Conduct system validation activities for assigned system(s) according to the industry expectations and regulations (CFR 21 Part 11, EU Annex 11, Gamp5, GCP)
- Work with system owners to develop custom reports, configuration changes, user management and training
- Act as KalVista representative with software vendors and manage ongoing relationships
- Serve as system administrator where appropriate
- Become a subject matter expert (SME) with clinical systems in order to provide technical assistance to the clinical team; escalate to the vendor as necessary
- Plan and conduct training sessions with KalVista staff on clinical systems
- Configure systems to best support clinical functions, including custom reports and visualizations
- Create and/or execute test scripts to validate the functionality of clinical systems
- Work with the vendor to track and prioritize bug fixes and enhancement requests
- Assist system owners in reviewing and approving vendor invoices, striving to keep projects within prescribed budgets
- Participate in on-boarding activities for users of KalVista systems
- Excellent verbal and written communication skills for effectively interfacing with internal departments and external collaborators
- Proven ability to work with a high level of integrity and raise issues when important or potential safety issues pose risk
- Strong technical & organizational skills to maintain a high level of productivity, innovation and priority-setting to effectively manage clinical systems
- Ability to identify and solve problems and to make thoughtful, integrated and timely decisions and take corresponding actions
- Self-motivated, assertive and self-confident with the ability to act with urgency and passion
- 2 years' relevant experience with clinical systems, clinical data management, system administration and/or database programming
- Bachelor's degree in Life Sciences, computer programming/information systems or equivalent experience
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Clinical Systems Specialist - Cambridge, United States - Kalvista Pharmaceuticals
Description
Clinical Systems SpecialistSalt Lake City, UT
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc.
) is focused on the discovery, development, and commercialization of novel, oral therapies for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE).
Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, UK; Zug, Switzerland; and Salt Lake City, UT.
The company has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization.
KalVista seeks a Clinical Sytems Specialist, which is critical to the organization's mission as it prepares to commercialize sebetralstat, a novel, oral plasma kallikrein inhibitor.
KalVista recently reported positive results from the KONFIDENT Phase 3 study which demonstrated that sebetralstat met all primary and secondary endpoints for the on-demand treatment of HAE attacks and the safety profile was comparable to placebo.
The Company plans to submit a new drug application to the U.S.Food and Drug Administration (FDA) in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024.
Reporting to the Director, Data Management & Systems, the Clinical Systems Specialist is responsible for ensuring KalVista Pharmaceutical's clinical systems are compliant with regulatory & industry expectations and providing ongoing support for the day-to-day operations of study teams.
Responsibilities:
Requirements:
