Technology Management

Luana AllcoƩ-Bleakney

Director Technology & Data SoluƟons

Framingham, MA 01701 /508-***-**** /ad7yf4@r.postjobfree.com Summary Seasoned, mulƟ-naƟonal team leader with experience leading technology and management teams through the full implementaƟon of mulƟ-variant technology soluƟons within regulated environments. A leader who is passionate about coaching and leading teams through the development, deployment, and operaƟonalizaƟon processes.

Employment History

2021 – 2024

Northbrook, IL

(Remote)

ASTELLAS PHARMACEUTICAL - Associate Director Data Management Systems, Data Science Originally a contractor where I lead the external development vendors (2 vendors, 8 players/team) through building custom reports (120+), analyƟcal frameworks (25+) and external data integraƟons (30+) to be used by the clinical teams (4 Teams). I then permanently joined the team where I conƟnued to coach the vendors on reducing overall development and deployment turnaround Ɵmes by 40%, capitalizing on process and development standards.

Managed the relaƟonship with 2 product support vendors, ensuring that issues were resolved completely and comprehensively. Performed root cause analysis resulƟng in product, process, or usage changes, when necessary to ensure KPIs met or document excepƟons. Performed coaching sessions for both operaƟonal (data management/clinical/medical) and technical

(development/IT) staff facilitaƟng adopƟon of product use, working to shiŌ from paper and spreadsheets to online analyƟcal tools, reducing Ɵme and increasing ability to reuse informaƟon. 2011 – 2021

Billerica, MA

PAREXEL - Director, Global Clinical ApplicaƟon Management Led operaƟons personnel to properly support and manage technology and data controls, ensuring stakeholders had key metrics and informaƟon to make criƟcal business determinaƟons. Technology focused on clinical drug development and data management-environments covering 50+ applicaƟons across SaaS, Cloud, and bespoke plaƞorms.

Worked closely with IT execuƟve management having established and implemented ITIL and related frameworks to address overall funcƟonal operaƟonal support models. Efforts achieved >85% reducƟon in turn-around Ɵmes; increased internal and external client saƟsfacƟon from <60% to >90%; and stabilized plaƞorms resulƟng 5 conƟguous years of improvements. Recommended global operaƟon process changes to external and internal clients to maximize their applicaƟon use and availability (average 99%); ensuring staff were trained to maintain said environments at high availability rates and reduce issue management commensurate to performance requirements. Started off as Associate Director, ended up maintaining the global staff of a maximum of 20, residing across 10 countries, while maintaining stability of both the personnel (average turn-over <8% with 10% growth for 7 years) while mulƟple major restructuring events.

2006 – 2011

Cambridge, MA

TOLERRX - Director, ScienƟfic Data

Established the Clinical and Lab Data Management department for the organizaƟon, including the development of operaƟonal SOPs, work instrucƟons, SDLC process, and documentaƟon procedures that ensured compliance with naƟonal (FDA), internaƟonal regulatory (ICH, EMEA), and corporate requirements. Managed clinical data management vendor relaƟonship, ensuring compliance to required performance and data reporƟng requirements.

Mentored and developed data management (3 people) and related colleagues (20+) to ensure solid data controls for corporate disciplines, including pre-clinical and clinical environments. Member of the assessment organizaƟon for determinaƟon of technology assessments for specific clinical, lab clinical and quality management systems.

Luana AllcoƩ-Bleakney Page Two

2002 – 2006

Brookline, MA

EASTERN COOPERATIVE ONCOLOGY GROUP - Chief InformaƟon Officer Managed $5 million budget and a team of 22 professionals; provided vision and direcƟon for corporate infrastructure and applicaƟons development; reduced costs by 15% within the first 4 months. Created a standardized SDLC/RAD development environment for clinical and operaƟonal systems, ensuring said environment in compliance with regulatory and government guidelines. Ending result being cleaner, clearer applicaƟon developed performed on Ɵme.

Implemented a mulƟ-level fiscal management environment (Deltek), thereby further reducing overall costs and providing greater detailed financial informaƟon to execuƟve management. Directed migraƟon and validaƟon of legacy Ingres environment to 3-Ɵer web architecture using Oracle/RDBMS and Oracle Clinical while not reducing the level of flexibility afforded by the custom related applicaƟon environment thereby meeƟng corporate goals and requirements. Redeveloped operaƟonal reporƟng and documentaƟon environments including, but not limited to clinical, data management, laboratory management, and finance resulƟng in a more well-rounded environment. 1994 – 2002

NaƟck, MA

MEDICAL & TECHNICAL RESEARCH ASSOCIATES/AAI PHARMA – Director InformaƟon Systems. Started employment as Sr. Analyst (1 year); promoted to Director aŌer reorganizaƟon. Managed $1 million budget and an internaƟonal team of professionals managing a global IT infrastructure. Team designed and implemented a series of applicaƟons comprised of project, sales, and operaƟons management. Products further enhanced in Domino and presented as SaaS resulƟng in a mulƟ-million-dollar revenue stream. Achieved ISO 9000 cerƟficaƟon and improved system availability from 60% to 99.99% by replacing and enhancing the exisƟng technology infrastructure using distributed applicaƟons, conƟnued reducing overall costs 10% to 6% of net income.

Fully validated and implemented Oracle Clinical and Oracle AERS while supporƟng the technical foundaƟon for the internally developed data management soluƟons. EducaƟon and Professional CerƟficaƟons

BOSTON UNIVERSITY, Boston, MA

Master of Business AdministraƟon

Master of Science, Management InformaƟon Systems

Bachelor of Music (Dual), Violin/Viola Performance Data AnalyƟcs CerƟficate, Cornell University, March 2021 ITIL V3 FoundaƟon CerƟfied, 2013

Project Management CerƟficaƟon, Boston University, 2010 AI in Pharma & Biotech CerƟficaƟon, MIT, 2024

Technical applicaƟon summary available upon request.

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