Clinical Systems Specialist

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.

About Sebetralstat

Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.

For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.

About the role: 

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: 
 

• Hands-on support of clinical systems and other KalVista applications such as data capture (EDC/ePro), randomization and drug supply (IRT), eTMF and analytics & reporting
• Conduct system validation activities for assigned systems) according to the industry expectations and regulations (CFR 21 Part 11, EU Annex 11, Gamps, 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
• Collaborate with system owners in writing SOPs, work instructions, user manuals, and training materials related to clinical systems
• Collaborate with system owners in completing user, audit and periodic reviews in timely manner across clinical systems
• Participate in on-boarding activities for users of KalVista system. 

Qualifications: 
 

• 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 

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

Important Notice to Third-Party Recruiters & Staffing Agencies: 

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service. 

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista. 

Thank you for your understanding and cooperation.