IT Capability Manager, Clinical
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
Arvinas is seeking an IT Capability Manager, Clinical, to define, implement, and manage IT capabilities supporting our rapidly growing Clinical organization. The IT Capability Manager will partner closely with Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, and Medical to help specify, design, implement, and support solutions that enable them to operate more effectively and efficiently.
The R&D Systems group is a strategic business partner for the R&D organization, defining IT requirements and providing leading-edge technology solutions. This position reports to the Head of IT, R&D Systems located in New Haven, CT. Hybrid work at our New Haven, CT headquarters is preferred, but full-time remote work is an option.
Key responsibilities of this role include, but are not limited to:
- Develop and maintain a thorough understanding of the business needs of our Clinical organization and how IT can enable them.
- Translate business needs into requirements. Define, scope, and budget for IT projects to address those business needs.
- Lead or participate in vendor selection, contract negotiation, and the development of statements of work.
- Implement and maintain collaboration solutions with CRO’s and other external partners.
- Provide full lifecycle ownership of applications and IT capabilities.
- Provide operational support as required for production systems, including end-user support, account management, configuration management, and change management.
- In partnership with IT Infrastructure and Operations, ensure that systems and processes are compliant with company security practices.
- Partner with internal groups to ensure systems are compliant with all applicable regulations and SOPs.
- Prepare system lifecycle documentation, end-user training and documentation, FAQ’s, and other documentation as required.
- 3+ years of experience in implementing and supporting IT systems that support clinical trials e.g., Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), SAS, Pharmacovigilance systems.
- Prior direct experience in the management and/or operation of clinical trials strongly preferred. Knowledge of the drug development lifecycle and clinical trial operations required.
- Experienced in managing IT capabilities/applications from concept to delivery through lifecycle management.
- Skilled in vendor selection and vendor management.
- Strong business analysis skills.
- Ability to balance strategic and operational work and appropriately manage multiple priorities.
- Experienced in application and systems support with strong troubleshooting and problem-solving abilities.
- Excellent written and verbal communication skills.
- Knowledge of GxP and other regulations governing pharmaceutical development and experience working with regulated systems.
- Knowledge of the Veeva platform is preferred.
- BS or other degree relevant to IT or life science discipline is required.
- Advanced degree a plus.
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity employer