Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Vice President, Data Management & Clinical Systems

  • Mar 2022 - Present

• Senior Director, Clinical Data Management

  • May 2018 - Mar 2022

  Head of Clinical Data ManagementOversight of internal Data Management team Oversight of external Data Management FSP and CROs to ensure that data and documentation are delivered on time and within budget Develop and manage relationships with DM FSP and CROs Supervise Agios clinical data managers and oversee internal Agios DM activities on all clinical studiesDevelop and implement Agios data management processes and lead standardization effortsCollaborate with DM Clinical Data Systems group and other key stakeholders from Clinical DevelopmentProvide Data Management expertise to teams Write data management SOPs and guidelinesEnsure all data management activities are conducted in accordance with GCP, internal SOPs and meet all regulatory requirementsPerform all study-level data management activities as necessaryProvide input to protocols for new studies, and other clinical study documents during developmentContribute to development and implementation of departmental initiativesLead selection of vendors, review proposals, budgets, scopes of work, as requiredManage and Develop DM StaffManage department budgetOversight of DM Clinical Systems TeamWork with Group Head to ensure appropriate management of clinical data warehouse and governing processesContribute to identification and selection of vendors for RBM, data visualization, and SDTM capabilities and best practicesImplement data visualization tools for oversight and monitoring of data quality and safety Show less

• Director, Clinical Data Management

  • Mar 2017 - May 2018

  Head of Data ManagementOversight of external Data Management FSP and CROs to ensure that data and documentation are delivered on time and within budget Develop and manage the relationship with DM FSP and CROs Supervise Agios clinical data managers and oversee internal Agios DM activities on all clinical studiesDevelop and implement Agios data management processes and lead standardization effortsPartner with the DM data systems group and other key stakeholders from Clinical DevelopmentProvide Data Management expertise to teams Write data management SOPs and guidelinesEnsure all data management activities are conducted in accordance with GCP, internal SOPs and meet all regulatory requirementsPerform data review periodically for quality issues and general data trends; generate queries as necessary Perform all study-level data management activities as necessaryCreate and produce in-process data reports to facilitate decision making on clinical trials Implement data visualization techniques to data cleaningProvide input to protocols for new studies, and other clinical study documents during developmentContribute to development and implementation of departmental initiativesLead selection of vendors, review proposals, budgets, scopes of work, as required Show less



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Clinical Data Management

  • Apr 2015 - Mar 2017

  Head of Biogen Data Management responsible for the organizational and operational strategy and leadership of Clinical Data Management, Clinical and Safety Coding, and Technical Data Quality, ensuring delivery of high quality data for effective and efficient reporting of clinical trials (Phase I-IV), regulatory submissions, and consultancy to Worldwide Medical. Accountable for the execution of portfolio deliverables through project, resource, and operational leadership, practicing effective- risk mitigation; capacity planning; vendor governance; delivery of technology solutions; and cross-functional communication. Develops and manages Annual Operating Plan for Data Management including budgets for external fees, project budgets, travel, and internal headcount. Collaborates and partners with leaders within Global Biometrics as well as the larger Development Sciences organization to align operational, vendor, and TA/Program data strategies and streamline cross functional communication. Ensures appropriate balance of in-house TA/Program/Study knowledge taking advantage of CRO expertise in best practices and advancements in technology, utilizing strong process for vendor oversight of quality and execution. Develops effective relationships with strategic partners and vendors by setting clear expectations for delivery and achievement of quality. Established a collaborative and successful cross company vendor governance structure now being used as a model across R&D to ensure goal achievement and innovation. Provides leadership in best practices for employee development through talent acquisition and retention; management; and development of staff. Implemented a Data Management Quality organizational structure with focus on clinical data quality, metrics development and monitoring, and best practices for eCOA development and system UAT. Implemented RBM model on several large Phase III global trials with emphasis on monitoring and trending of critical data and triggers Show less

• Associate Director, Data Management Operations

  • Jan 2013 - Apr 2015

  Developed strategy and organizational structure for Data Management Project Management Group within Data Management function. Responsible for oversight of all data management operations associated with the execution of phase I- IV clinical trials. Responsible for the recruitment, training and development of staff. Ensured that quality data was provided for submissions according to timelines . Participated in capability building initiatives and contributed to the strategy and vision for the larger Clinical Data Management Department (CDM) Show less

• Sr. Manager, Late Phase Center of Excellence, Data Management

  • Sep 2008 - Jan 2013

  Provided operational and organizational leadership for the Late Phase Center of Excellence (Phase 2-4) Delivered high quality on time data by motivating and managing a team of Data Management Project Managers (DMPM) overseeing Functional Service Provider (FSP) partners. Advisor and consultant for data management activities. Oversight of FSP relationships in partnership with Vendor Managers. Mentored and managed DMPM staff including identification of training needs and compensation management. Recruited and developed new staff. Show less



PAREXEL International

• Group Manager, Technical Operations North America

  • Jul 2006 - Sep 2008

  Provided operational and organizational leadership for all development and programming activities oversight of the execution, timeliness, and quality of all technical deliverables for EDC/CDMS systems and clinical programming for entire North American portfolio. Achievements include the integration of EDC development personnel into North American Technical Operations Team; Growth of Global EDC team from 2 to 14 staff with developers in Waltham, UK, South Africa and Berlin within a one year period. Development of all EDC related processes, SOPs, standards and templates for InForm projects. Institution of Quality Gate Process for Database development resulting in a 75% increase in TMF compliance and significant reduction in errors reported Show less

• Project Manager/Group Manager, Clinical Data Management

  • Sep 2000 - Jul 2006

  Provided operational and organizational leadership for all DM activities including oversight of execution, timeliness, and quality of all deliverables for North American Office. Mentored, trained and supported several managers and up to 28 indirect reports. Proposal and contract review, estimation of project resource requirements, monitoring of project timelines to ensure high quality, on time deliverables.



PAREXEL International

• Waltham, MA

• Clinical Data Manager

  • 1997 - 2000

  Created CRFs, data cleaning specifications, system UAT, data management plans and other key project documentation, Coordinated project execution and resources , Communicated project updates and metrics. Managed a team responsible for reconciling all vendor data on a large international study. Created CRFs, data cleaning specifications, system UAT, data management plans and other key project documentation, Coordinated project execution and resources , Communicated project updates and metrics. Managed a team responsible for reconciling all vendor data on a large international study.