Associate/Sr. Associate – CTF Business Process Support

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for patients around the world.

Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.

Clinical Trial Foundations (CTF) as part of Clinical Design, Delivery & Analytics (CDDA) provides leadership in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally. The Business Process Systems Support role will support the Vault Clinical and SIP systems used in the management of clinical trials, as well as a number of smaller ancillary systems. The role will be based in the Global Business Solutions (GBS) center in Cork, with daily functional interactions with the wider teams in the US and our sister site in India. Working closely with colleagues in CDDA and other components of the R&D organization, the Clinical Systems Support role will help deliver operational support to the users of these systems.

Primary Responsibilities:

• Maintain and grow a strong working knowledge of Vault Clinical, SIP and the other ancillary systems used within the Trial Management Systems space.
• Provide technical knowledge and operational support for all systems within this space.
• Be able to navigate in applicable clinical trial systems and resources to locate data.
• Inbox ticket management and prioritization for operational issues raised.
• Resolve issues quickly to ensure continued access; apply root cause analysis as needed.
• Identify operational risks and issues and raise concerns appropriately.
• Apply knowledge and experience to continuously improve functionality and efficiency.
• Provide as needed support and testing for installation of new releases and patches by providing operational expertise, associated training, and business process development.
• Partner with system support to come up with solutions for new use cases and operational gaps.
• Understand, respond and escalate customer feedback on systems.
• Review appropriate SIP and Vault Clinical reports to assess data completeness for the assigned study/area and take immediate action to address any discrepancies found.
• Understand how own responsibilities affect trial activities and have regulatory/safety implications.
• Manage user access to relevant systems, ensuring that users have met the access requirements.
• Support internal audits and external inspections as needed.
• Develop and support user training as needed, including maintenance of job aids, FAQs, knowledge base, etc.
• Develop and maintain metrics as needed.

Minimum Qualification Requirements:

• Bachelor's degree in Computer Science or IT, preferred – but experience in a technical role is also accepted in absence of a degree.
• Applied experience in medical, quality, clinical drug development, or clinical information flow, preferred.
• Excellent oral and written communication skills; ability to communicate clearly and succinctly with team members.
• Excellent self-management and organizational skills; able to manage workload, set personal priorities and adjust as needed.
• Strong interpersonal skills.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Strong customer focus.

Other Information/Additional Preferences:

• Experience in clinical development data systems as well as current and evolving technologies to support clinical development would be advantageous.
• Knowledge and/or experience in an operational support role, but not limited to, a clinical system environment would be preferred.
• A European language in addition to English.
• Strong leadership skills.
• Strong collaboration and teamwork skills.
• Demonstrated strength in logical thought, problem solving ability and critical thinking.
• Ability and experience in building consensus and resolving conflict to drive progress.
• Flexibility in approach and/or high learning agility.
• Ability to adjust to unexpected business opportunities whilst also being a catalyst for positive change.
• Knowledge of regulatory and quality requirements governing clinical data development.
• Limited travel, including international, up to 10%.