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Associate Director, Enterprise Applications (R&D Systems)

Irvine, California, United States

Hi Tarsan! 

Thanks for your interest in this position.  Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better.  

- Your Human Resources Team

About the Role

As an Associate Director, Enterprise Applications – R&D Systems, you will act as a hands-on technology expert and IT system owner for Veeva clinical and regulatory platforms. You will collaborate closely with the respective business functions to lead the implementation and support of these systems and work closely with Quality and external vendors to support computerized system validations.

Let’s talk about some of the key responsibilities of the role:

  • Act as a subject matter expert and application lead for R&D, clinical, regulatory and quality business functions in biopharmaceutical environment
  • Lead and own IT roadmap and implementations for Clinical and Regulatory teams and be hands on technical expert with solution design, system configurations, testing and validation
  • Perform requirement gathering, risk assessment, impact assessment of new and existing systems
  • Collaborate with business stakeholders, IT and external vendors to prioritize and implement new business capabilities and provide day-to-day operations support for clinical and regulatory systems
  • Work with business stakeholders, vendors and quality teams to lead the implementation of Veeva clinical systems such as Vault EDC, CDB, RTSM and Veeva Vault RIM platform for regulatory function. Act as the IT system owner for these platforms
  • Collaborate with quality team and external vendors on GxP systems operations, Change management, CAPAs and computerized systems validation
  • Lead requirement gathering, solution design and user acceptance testing of system changes to ensure quality production deployments
  • Lead the implementation and support of Clinical data analytics solutions
  • Review and own IT activities for change control requests and provide all required documentations for clinical systems
  • Assist clinical team with data management, migration, and analytics for study related data in EDC
  • Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness
  • Develop, review and update standard operating procedures (SOPs) and policies related to GxP systems

Factors for Success:

  • Bachelor’s degree in computer science, Information Systems, Engineering, Quality, Regulatory, or Business, with 12+ years of relevant IT experience
  • 7+ years of relevant experience in architecting, implementing and supporting clinical and regulatory systems in a life sciences and pharma industry
  • Experience with business processes and System Development Lifecycle (SDLC) in a GxP regulated environment is a must
  • 5+ years of relevant experience with implementing and supporting clinical and regulatory systems
  • Strong knowledge and hands on experience implementing Electronic Data Capture EDC and other clinical platforms and data management solutions, preferably with Veeva EDC and clinical platforms
  • Proficiency in configuring and maintaining Veeva vault applications
  • Strong knowledge in Regulatory operations and hands on experience implementing and supporting Regulatory management systems preferably Veeva Vault RIM system. Certifications in Veeva EDC, RIM will be a plus
  • Experience in implementing other clinical systems such as eTMF, CTMS and Payments solutions will be a plus
  • Good knowledge and experience in building and managing Cloud environments and building clinical data warehouse and visualization and dashboards using tools such as Spotfire, Tableau or PowerBI
  • Good understanding of technologies such as SQL, SOQL, REST, SOAP, HTML5, JavaScript, Python or R and supporting statistical tools such as Minitab and JMP
  • Stay updated on new technologies and trends, ensuring the company derives optimal value from both current and prospective solutions or technologies under consideration for adoption
  • Familiar with waterfall and/or Agile project management methodologies
  • Very good communication and problem-solving skills
  • Self-starter: able to work independently, proactively identify challenges, and be accountable
  • Experience in leading multiple vendors such as software providers, system integrators and managed services partner on projects and support

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment
  • Remote will be considered, but preference will be given to onsite/hybrid candidates
  • This position reports directly to our Vice President of Digital and IT
  • Some travel may be required – up to 10%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $161,200 - $225,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.

#LI-Hybrid

#LI-Remote

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