Stephen Feeley Email & Phone Number

Mansfield, Massachusetts, United States

Mansfield, MA

• Extended Leadership Team member providing strategic insights to maximize Medtronic Clinical Operations technology investments.
• Develop relationships with Global IT and clinical partners to improve collaboration necessary to accomplish organizational objectives
• Evaluate shifts in operational execution support inter-departmentally to support all Medtronic Sponsored Clinical Trials.
• Proactively anticipate future business needs and identify enabling solutions early, often prior to official business requirements process.
• Develop understanding of general industry technology trends and business dependencies around supported technologies.

Mansfield, MA

• Oversee the work and assess resourcing for all US EDC Study Development, CRF Standards and Study Management Reporting Staff across Medtronic plc, continuously assessing the need for vendor resources.
• Develop short and long range operating objectives, organizational structure, and staffing requirements to support new processes and technologies that are being developed across business units.
• Coach, motivate and foster professional development of direct reports, including creation of attainable objectives and goals.
• Produce resource forecasts for new studies and scope changes across the organization.
• Assist in any FDA, PMDA or other internal GCP/quality or external competent authority audits involving Clinical Data Management.
• Drive team to continuously improve and streamline processes in support of the Clinical Data Management lifecycle.

Mansfield, MA

• Direct the global teams in the evaluation and implementation of Data management and Trial Management solutions.
• Direct the global teams towards standardization of objects and processes in all functional areas to gain business efficiencies.
• Oversee all activities, staff and vendor resources for a Clinical Systems team, residing within the Corporate Covidien Clinical Operations organization, responsible for providing operational execution across all.
• Oversee external vendors for multilingual EDC helpdesk, technical support, software implementation, and training services.
• Manage teams supporting EDC User Administration, CTMS, Reporting and Metrics, and EDC database builds and data transfers.

Mansfield, MA

• Oversee and lead personnel performing the initial planning and ongoing execution of Clinical System implementations and upgrades.
• Provide input to strategic direction of the Enabling Technologies needed to support a growing Clinical Affairs organization.
• Manage vendors and facilitate cross-functional dialogue to optimally design clinical systems and processes to meet business needs.
• Proactively identify opportunities to leverage existing system capabilities to improve business process.
• Coordinate and track large project timelines, milestones, budgets, key accomplishments, and risks and mitigations.
• Provide support for the TMS Medical Coding System (MedDRA + WHO Drug) and NormLab2 reference range subsystem.

Mansfield, MA

• Supervise, and mentor direct reports, contractors, consultants and vendors in Covidien best practices.
• Contribute to Clinical Systems road-map for further system enhancements to optimize functionality and compliance.
• Lead the integration of personnel from small to large acquisitions (e.g. ev3, Somanetics) into Covidien’s Clinical Systems.
• Provide support for Clinical System and Clinical Data Management Workstreams to support for cross company re-organization.
• Work with team members from Medical, Clinical and Data Management to ensure compliance around the use of clinical systems.
• Implement ad-hoc reporting environment and secure site document delivery capability within EDC.

Mansfield, MA

• Support clinical system deployment across multiple global businesses including Pharmaceuticals, Vascular, Respiratory and Surgical.
• Act as a Liaison between external vendors and internal staff to see study database or system integration projects through completion.
• Develop Standard CRF templates, leveraging CDASH and CDISC SDTM, to decrease Study Build cycle timelines.
• Develop new Work Instructions and Modify Existing Work Instructions to reflect and guide common best practices.
• Lead a new integration from EDC to CTMS, including onboarding and training of new users.

Bedford, MA

• Design and create EDC databases and program validations checks and derivations, including post-production changes as required.
• Assist in the development and review of CRFs, CRF completion guidelines, DMPs, and edit check specifications.
• Develop status reports/metrics, including data verification and other ad-hoc listings to support data cleaning or audit activities.
• Support the team in any study startup and closeout activities including final report data QC.
• Support the on-going needs for batch data loads and other data transfers from legacy platforms.

Quincy, MA

• Ensure that all data for clinical studies are planned and performed in accordance with specific project guidelines; contractual obligations; ICH, GCP and FDA guidelines; along with Premier Research Group’s SOPs.
• Develop clinical trial databases and program validation and derivation consistency checks using Oracle Clinical.
• Perform quality testing on database builds, edit checks and paper Case Report Forms using manual checks and automated reports.
• Mentor database developers and associate database developers.
• Perform client gap assessments on SOP requirements for FDA Compliance.
• Perform Quality Control Reports for wide array of client clinical studies.

Quincy, MA

• Design clinical trial databases using Oracle Clinical 4.5.3 for Paper, RDC Classic, RDC PDF, and RDC Onsite studies.
• Develop case report forms (CRF) in Teleform for paper studies.
• Create validation and derivation procedures, including custom coded procedures using Oracle’s SQL.
• Compile and compose monthly metric data, from the clinical database using Toad, and create graphical presentations for clients
• Train and mentor new employees in both remote and on-site locations.

Quincy, MA

Develop clinical trial databases using Oracle Clinical.Provide validation and derivation procedures for studies. Program in accordance with Data Management (DM) procedures and guidelines to the supplied user requirements. Ensure all new and modified procedures are tested. Ensure that all documentation is completed per applicable SOPs with the appropriate.

Quincy, MA

• Prepare all materials for new accounts and exchanges, and assist in the analysis of new products and services.
• Research and evaluate external vendors to identify the most appropriate products and services.
• Computer Management: MS Office: Word, Excel, PowerPoint, Access, Outlook, FrontPage and Publisher; Macromedia Applications; QuickBooks; Photoshop; Internet Security Software; Network Backup and Recovery; Hardware.
• Establish an office network and convert traditional services for faxing, e-mail, and banking to all electronic.
• Develop an in-depth sales binder to target new clients, plan sales routes, and mine data gathered from client visits.

Quincy, MA

-Served as only teacher for freshman year student-Devised curriculum, activities, and exams in English, Math, Science, and History-Worked creatively to motivate student in group home setting-Successfully integrated student back into public school, above anticipated grade level, upon conclusion of tutoring

B.A., Zoology

Activities and Societies: Co Co BeauxPre-Med

E.M.T., Emergency Medicine

Activities and Societies: E.M.T. Certification - Renewed December 2006

Certification, Disaster Services Team

Activities and Societies: Introduction to Disaster Services, Community Services Overview, Shelter Operations

High School

Activities and Societies: Founded Avid Club, Freshman and JV Soccer, Drama Club, Ski Team, Choral Spectrum, WHHS TV