Experience

Science 37

• United States
• Research Services
• 200 - 300 Employee

• Sr. Project Manager

  • Dec 2021 - Present



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Senior Clinical Programs Scientist

  • Sep 2015 - Present

  Responsible for the planning, implementation, execution, and management of more than one clinical research studies.  Manages clinical outsourcing to CROs and other vendors such as IVRS, IRBs, Laboratories etc.  May author review and approve various study related documents and plans.  Evaluates issues, interpret data, and suggest and implements solutions and mitigation strategies as required.  Responsible for the financial management of the study and develops and oversee study timelines.  Provides input as the subject matter expert for the study during regulatory inspections.  Executes clinical study in accordance with the project clinical development strategy timelines.  Responsible for the clinical review and approval of Case Report Forms (electronic as applicable) and provide clinical input for corresponding completion guidelines.  Responsible for the oversight and identification and selection of Investigator sites.  Responsible for planning and conducting of Kickoff and Investigator Meetings.  Provides input and coordinates the delivery of clinical trial supplies in collaboration with CS team.  Responsible for the development of the Protocol Synopsis, Informed Consent form for clinical trials.  Provides clinical input in the development of the Protocol for clinical trials.  Responsible for selection and management of vendors.  Oversee and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans. Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Operations Leader

  • Nov 2014 - Sep 2015

  Was responsible for the coordination functional groups and activities across all geographies, providing leadership and guidance to project team members  Liaise with project leadership and sponsor to ensure all deliverable's were met  Evaluate and identify resourcing needs and continuously monitor over life cycle of project  Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project Was responsible for the coordination functional groups and activities across all geographies, providing leadership and guidance to project team members  Liaise with project leadership and sponsor to ensure all deliverable's were met  Evaluate and identify resourcing needs and continuously monitor over life cycle of project  Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project



Quintiles

• Miami/Fort Lauderdale Area

• Independent Contractor

  • May 2013 - Nov 2014



Research Pharmaceutical Services

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Associate Director Project Management

  • Apr 2011 - May 2013

  Provided line management oversight for the Project Manager (PM) and Project Assistant (PA):• Tracked current PA utilization to gauge adequate resources and request additional staff from management when necessary • Assisted in the interviewing and hiring process of Project Manager and Project Assistant candidates as required for research projects according to Sponsor needs • Provided oversight for direct reports including (1) approving and tracking of PTO requests, ensuring adhesion to the current RPS policy for PTO submission, (2) approving timesheets ensuring that adhesion to the current RPS policy for timesheet submission, (3) approving expense reports ensuring that all PM Staff adhere to the current RPS policy of expense report submission. • Mentor new Project Managers in accordance to the Project Management Mentorship Program • Evaluate and address employee performance through Sponsor feedback • Establish and monitor performance metrics • Conduct annual performance evaluations for direct reports • Provided Director, Project Management with current utilization information so that PMs can be assigned to new projects • Participate in the monthly Client Activity Status Report (CASR) Meetings• Assisted Strategic Development and provide input to proposals as necessary (i.e. Sponsor Meetings, capabilities presentations, bid defense conference attendance). Attend capabilities presentations as necessary. • Act as a liaison between Sponsor and deployed employee/team in order to manage and provide high-level oversight• Interact with other RPS departments where required such as Human Resources, Staffing and Finance • Enhanced overall effectiveness of the Project Management Department • Ensured all programs under his/her oversight are conducted in accordance to SOPS (i.e. either RPS’s or Sponsor’s) • Provided clinical and FDA/ICH support for other areas within the company Show less

• Senior Project Manager

  • Apr 2010 - Mar 2011

  • Managed multiple full scope projects from planning phase to analysis phase for delivery to client. • Mentored Associate Project Managers• Coordinated project organization, implementation and management activities between all functional areas and the client serves as primary contact for all projects related issues.• Prepared the project plan and timelines and monitors against project progress; ensures project activity compliance with plan.• Provided a leadership role in managing multiple Phase I through Phase IV clinical research trials across all functional areas. This position oversees and coordinates the operational aspects of ongoing projects to ensure meeting the client's goals of time, cost, and quality performance expectations.• Provided administrative oversight for direct reports including (1) approving ad tracking of PTO requests, ensuring adhesion to the current RPS policy for PTO submission, (2) approving timesheets & expenses ensuring adhesion to the current RPS policy for timesheet & expense submission.• Conducted monthly project team meetings.• Prepared project status reports• Established appropriate clinical budget tracking using computer assisted programs.• Participated in monthly Client Activity Report Status (CARS).• Prepared and presented study material at client meetings and communicated outcomes to project team. Show less

• Project Manager

  • Dec 2008 - Mar 2010

  • Provided a leadership role in managing multiple Phase I through Phase IV clinical research trials across all functional areas. This position oversees and coordinated the operational aspects of ongoing projects to ensure meeting the client's goals of time, cost, and quality performance expectations• Coordinated project organization, implementation and management activities between all functional areas and the client. Serves as primary client contact for all project related issues.• Assessed resource needs with functional area managers and establishes appropriate project team. Monitors ongoing resource needs to project. Show less



OMNICARE CLINICAL RESEARCH INC (Theorem)

• Clinical Trial Manager

  • Aug 2006 - 2008

  • In a matrix environment, managed, lead and motivate the assigned cross functional project team, facilitating the team’s ability to fulfill their responsibilities in accordance with project contracts, contract amendments and Omnicare Clinical Research policies, procedures and SOPs.• Developed and maintained relationship with the client’s study management team(s).• Determined appropriate revenue forecasting and revenue recognition based on project plan, budget and contract deliverables.• Tracked budget and scope changes, obtaining necessary client approvals for change in scope of work. Initiate and follow up on change order/contract amendment activities.• Review, approve and follow-up on project invoices.• Managed project resource needs and utilization according to project contract and contract amendments.• Communicate and coordinate project timelines for all required project functional service areas, client and third party vendors, as required.• Plan and lead client meetings and project team training sessions.• Accountable for developing and maintaining project metrics, timelines, and deliverables.• Lead internal team, client and other project related teleconferences and meetings (may include agenda and meetings minutes preparation/review.)• Communicated expectations for roles and responsibilities to assigned project team members and ensure those expectations are fulfilled.• Functioned as primary liaison between client, third party vendors and Omnicare Clinical Research project team for project issues, including initiation, planning, execution and closeout of assigned studies.• Proactively communicated to appropriate Omnicare Clinical Research management, client and third party vendors as warranted about project progress, potential issues and recommendations for issues resolution, i.e. Global Project Management Process (GPMP), etc.• Participated in business development activities as required. Show less

• Senior Clinical Research Associate

  • Jul 2001 - Aug 2006

  Identified of potential investigational sites • Monitored investigational clinical trials Phase II-IV in various therapeutic areas • Coordinates and performs comprehensive site management • Conducted of pre-study, initiation, interim and close out monitoring visits • Produced comprehensive visit reports and status reports • Resolved data issues and audit issues • Adherence to the study timelines and budget • Mentored less experienced CRA’s Lead CRA responsibilities •Within International − when applicable, the collection of high quality critical documents and completion of ethics committee and regulatory submissions in association with Investigator Services Show less



Omnicare, a CVS Health company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Jan 1999 - Jul 2001

  Identified of potential investigational sites • Monitored investigational clinical trials Phase II-IV in various therapeutic areas • Coordinates and performs comprehensive site management • Conducted of pre-study, initiation, interim and close out monitoring visits • Produced comprehensive visit reports and status reports • Resolved data issues and audit issues • Adherence to the study timelines and budget •Mentored less experienced CRA’s •Within International − when applicable, the collection of high quality critical documents and completion of ethics committee and regulatory submissions in association with Investigator Services. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Contract Clinical Research Associate

  • Oct 1998 - Jan 1999



Cell pathways

• Horsham PA

• Contract Clinical Research Associate

  • Sep 1998 - Oct 1998



Cytogen Corporation

• Biotechnology
• 1 - 100 Employee

• Clinical Studies Assistant

  • Jan 1996 - Sep 1998