Clinical System Administrator

3 weeks ago

Bengaluru, India Allucent Full time

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Clinical System Administrator to join our A-team (hybrid*). As a Clinical System Administrator at Allucent, you will be responsible for the configuration, maintenance, and administration of clinical systems, with a primary focus on Veeva Vault applications (eTMF, CTMS, Payments, etc.) and pharmacovigilance systems. This role is critical to ensuring the seamless operation of these platforms, supporting clinical trial activities, and ensuring compliance with regulatory requirements. The Clinical Systems Administrator will have hands-on experience with Veeva Vault products, as well as knowledge of pharmacovigilance systems used for safety reporting and adverse event management. The Clinical Systems Administrator will collaborate with internal teams, including clinical operations, IT, and pharmacovigilance, to optimize system performance and provide end-user support.

In this role your key tasks will include:

  • Administer and configure Veeva Vault applications (eTMF, CTMS, Payments, etc.), ensuring the systems are operating efficiently and in compliance with regulatory standards (FDA, ICH).
  • Support the administration and maintenance of pharmacovigilance systems, ensuring compliance with safety reporting requirements and regulatory standards (FDA, EMA).
  • Provide technical support to end-users across clinical operations, pharmacovigilance, and other departments. Train users on system functionality, best practices, and regulatory compliance requirements.
  • Lead efforts to configure clinical and pharmacovigilance systems according to business needs, optimizing workflows, and ensuring alignment with operational goals.
  • Ensure data integrity and proper system validation according to regulatory standards. Assist with audits and inspections as needed to demonstrate compliance with regulatory requirements.
  • Manage system changes using proper change control procedures. Maintain comprehensive documentation of system configurations, user access, and administration activities.
  • Collaborate with clinical operations, pharmacovigilance, quality assurance, and IT teams to ensure that system enhancements and configurations meet business and regulatory needs.
  • Work with IT to ensure clinical and pharmacovigilance systems are properly integrated with other enterprise applications, such as ERP and data warehouses, to ensure seamless data flow and reporting.
  • Liaise with Veeva and other third-party vendors to resolve system issues, manage updates, and ensure the systems are functioning according to business and regulatory requirements.
  • Develop and maintain reports and dashboards for clinical and pharmacovigilance data, supporting business decision-making and ensuring compliance with reporting requirements.
  • Review, improve and evaluate IT processes and procedures within the Quality Management System.

Requirements

To be successful you should possess:

  • Bachelor's degree in Life Sciences, Information Technology, or related field. Equivalent experience may be considered.
  • Minimum of 3-5 years of experience in administering clinical systems, with specific experience managing Veeva Vault applications (eTMF, CTMS, Payments, etc.). Experience with pharmacovigilance systems for adverse event reporting and safety data management is preferred.
  • Strong understanding of system administration, configuration, and integration for Veeva Vault and pharmacovigilance platforms. Basic knowledge of database management and reporting tools is a plus.
  • Familiarity with clinical trial processes, regulatory requirements (FDA, GCP, ICH), and pharmacovigilance standards (such as E2B for electronic adverse event reporting).
  • Experience with system validation, data integrity, and compliance in a regulated environment (GxP).
  • Experience managing relationships with external vendors, including coordinating system updates and troubleshooting.
  • Veeva Vault Administrator Certification is a plus. Knowledge of pharmacovigilance regulations and software (such as Argus, ArisGlobal) is highly desirable.
  • Ability to work in a fast-paced challenging environment of a growing company.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
  • Strong analytical and troubleshooting skills with the ability to diagnose and resolve system-related issues in a timely manner.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Detail-oriented with excellent organizational skills and ability to manage multiple projects simultaneously.

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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