Clinical Data Management

Michael C. Lyons

Cell phone: 617-***-****

Address: ** ***** ******* ****

Burlington, MA 01803

Email: ******@***.***

SUMMARY OF EXPERIENCE:

Clinical Data Manager (CDM) experienced in overseeing and performing data management (DM) activities in clinical trials across all phases of clinical drug and device studies in Clinical Research and the pharmaceutical industry. After working in multiple capacities and performing duties from study start up to database lock, I understand the complete life cycle of a clinical trial, seen from multiple perspectives. I possess knowledge spanning extensive therapeutic areas and indications due to exposure to a variety of studies.

SELECTED SKILLS:

Outsourced Data Management oversight

Cross-functional Data Review Plan (DRP)

Electronic Case Report Form (eCRF) design

External data reconciliation

Authoring Data Management Plans (DMP)

Database lock

User Acceptance Testing (UAT)

Inspection Readiness

Microsoft Office

PROFESSIONAL EXPERIENCE:

Senior Clinical Data Manager, Alnylam Pharmaceuticals, Cambridge, Massachusetts

(May-November 2015 as contractor; Full time employee until 2021) THERAPEUTIC FOCUS: Rare diseases caused by liver-based genetic mutations (including Primary Hyperoxaluria TYPE 1 [PH1,] hypercholesterolemia and TTR Amyloidosis)

• Prepared study documentation for Good Clinical Practice inspection readiness and participated in mock inspections

• Led Phase I, II and III studies to approval

• Oversaw and ensured timely completion of timeline-guided DM activities in support of multiple Alnylam clinical studies, including eCRF development, DMP, edit-check specifications (ECS), database build, UAT, maintenance, mid-study updates, data collection, data coding, cleaning, analysis and data archiving from study start until database lock

• Managed Contract Research Organization (CRO) DM activities in accordance with fully outsourced model, including oversight of query resolution, coding, Serious Adverse Event (SAE) reconciliation activities, CRO-drafting of timelines consistent with company goals and external data delivery and reconciliation

• Collaborated as Lead Data Manager with internal partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs and external partners such as CROs, central and local labs

• Provided DM guidance in the development of clinical protocols, clinical study reports and other regulatory documents, e.g. Drug Safety Update Reports (DSUR), Briefing Documents, and Clinical Study Report (CSR)

• Authored cross-functional DRP, coordinating and performing frequent DRP-based review

• Ensured DRP queries were posted in EDC, answered in a timely manner and satisfied findings

• Presented evidence of Adverse Event data in data monitoring committee meetings Contract Clinical Data Analyst III, PAREXEL International, Billerica, Massachusetts May 2014 - March 2015 THERAPEUTIC FOCUS: Psoriasis

• Reviewed data listings and posted queries in EDC, processed responses, re-querying/closing as appropriate

• Led database lock activities

• Collaborated with Clinical Research Associates to allow site staff to access and update frozen eCRFs during study milestones

• Provided subject matter expertise during study team meetings Senior Clinical Data Manager, ARIAD Pharmaceuticals, Cambridge, Massachusetts March 2013 – November 2013 THERAPEUTIC FOCUS: Oncology-Leukemia/GIST Led in-house DM activities, including

• Provided DM leadership in protocol review, form design and specifications for newly conceived trials, including Data review guidelines and eCRF completion guidelines

• Defined edit checks and developed data validation in Electronic Data Capture (EDC) system and documented in the ECS

• Represented DM perspective during project study team meetings

• Managed vendor EDC Programming team to ensure system build and update timelines were met

• Generated metrics to track and report data status

• Developed UAT plans and performed UAT to confirm programmed checks operated per ECS

• Reviewed and provided feedback for Statistical Analysis Plan and Medical Monitoring Plan Clinical Data Associate/CDM, PROMETRIKA LLC, Cambridge, Massachusetts April 2008 – March 2013 THERAPEUTIC FOCUS: Oncology-Solid Tumors; Type 1 Diabetes; COPD

• Ensured database and annotated Case Report Forms (CRF) were set up in accordance with study contract and SOPs

• Followed logging and tracking procedures for patient documentation retrieved from study sites

• Planned and managed resources for efficient project operation

• Authored study-specific DMP

• Created Data Validation Guidelines and updated as the study required

• Implemented, oversaw and performed quality control for database lock activities

• Conducted reconciliation of serious adverse events

• Managed Email & Telephone Information Line, answering questions from patients and creating and presenting relevant metrics

• Organized and participated in client team meetings as required, including preparation/distribution of meeting agenda and approval/distribution of meeting minutes

• Developed test data to validate data check programming

• Generated status and metric reports

• Authored queries to study sites in EDC when missing, incorrect, or inconsistent data were identified through data review procedures

• Followed up on query responses to confirm issues were completely resolved EDUCATION:

Boston College, Chestnut Hill, MA, B.A. Classics

ELECTRONIC DATA CAPTURE SYSTEM experience:

Medidata Rave; InForm; Oracle Clinical; MedNet; Outcomes PROFESSIONAL ACCREDITATONS:

SDTM Theory and Application Certification by Clinical Data Interchange Standards Consortium, Inc. Certified Clinical Data Manager (SCDM) 2012 - 2020

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