Adam Kelch

Fully assigned in Data Architect role to large, multi-national, private Life Sciences company for design, architecture, and implementation oversite of complex data analytics project. Duties included managing end-to-end process, from data ingestion and cleaning, to curation and creation of data products in Clinical and Regulatory domains for use in reporting and by data scientists. Data source technologies included multiple cloud service providers and on-prem bespoke solutions. Analytics platform technologies entirely cloud-based including AWS (e.g. Glue, Appflow, Airflow, Cloudwatch, IAM), Collibra, Snowflake, and Tableau.

• Recruited and managed global team of solution architects to support projects across portfolio of 50+ applications in regulatory affairs landscape, strong focus on digital transformation and enterprise data management and exchange, while ensuring systems were integrated across all global drug development domains.
• Led two initiatives from IT side on selection and implementation of new document management systems (Veeva Vault) for managing RIM and eTMF documentation. Provided strategic guidance and input from RFP crafting through vendor selection and implementation.
• Launched regulatory business capabilities re-creation, collaborating with cross-functional sub-domain teams to conduct in-depth assessments, resulting in detailed mapping of current and target state capabilities. Initiative directly informed strategic decisions, ensuring technology solutions were aligned with business needs within budgetary constraints. Followed TOGAF standard.
• Established and enforced solution governance framework, facilitating rigorous evaluation of proposed IT solutions against enterprise architecture principles by developing and maintaining architectural documentation, standards, and guidelines to ensure consistency across projects and teams.

• Collaborated with project sponsors, both IT and business, to successfully stabilize over $50m project which was at risk, working with multiple internal and external global groups. Leveraged communication skills to distill complex problems and technologies into clear and unambiguous terms so those with varying degrees of knowledge could comprehend. Used SAFe framework.
• Recruited and led internal regulatory software service delivery team, replacing external consultants, resulting in multi-million-dollar savings.

• Drove maturity of Life Science solutions with specific focus on clinical operations.
• Key contributor of sales team to close dozens more global customers, establishing solutions as market leader.
• Collaborated with leading industry software vendors to design and develop product integrations.
• Member of TMF Reference Model, including Subcommittee on Sponsor/CRO Exchange.

• Recruited and led global team on creation of all 3 EMC Documentum Life Sciences solutions (Regulatory, eTMF, and Quality and Manufacturing) from inception to market-ready in startup-like environment.
• Collaborated on dozens of sales of solution, including Sponsors and CROs, responding to RFPs and engaging with prospective customers by giving presentations and performing demonstrations to large audiences.

Designed and created software accelerators which provided customers blueprint and starting point to implement business processes.

As a consultant, drove customer design and implementation of applications across industries throughout Europe on document management solutions

Implemented and maintained Mobistar mobile web application

Programmer on content management solutions, including pre-sales and consulting

Mainframe and C++ programmer for the Space Shuttle math model simulator