Experience

InClin, Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate/Regional Study Manager (Oncology)

  • Mar 2021 - Present

  Support the Project Manager in the day-to-day operational management of studies including oversight of vendors and clinical sites.• Act as the point of contact with the sponsor• Author and contribute to the development of study plans (i.e., project management plan, clinical monitoring plan) and monitor compliance with same• Manage study team to deliver services within scope, budget, and timeline• Liaise with internal stakeholders to ensure alignment with study goals and timelines• Contribute to the development of feasibility questionnaires and their use in site selection• Develop study specific ICF based on existing template and review/approve changes requested by sites• Work with sites to collect, review and approve regulatory documents in preparation for site activation• Develop and submit initial/updated central IRB applications and maintain communication with the IRB, as needed• Support CRAs in site start up and management activities• Supervise vendor activities



Daiichi Sankyo, Inc.

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Clinical Study Associate (Oncology)

  • Jan 2018 - Sep 2021

  Assist in the planning and execution of clinical studies with a focus on interaction with the Contract Research Organizations (CROs) and other vendors to help monitor compliance with GCP/ICH and Company Quality Oversight measures. • Act as the point of contact with the sponsor• Author and contribute to the development of study plans (i.e., project management plan, clinical monitoring plan) and monitor compliance with same• Manage study team to deliver services within scope, budget, and timeline• Liaise with internal stakeholders to ensure alignment with study goals and timelines• Contribute to the development of feasibility questionnaires and their use in site selection• Develop study specific ICF based on existing template and review/approve changes requested by sites• Work with sites to collect, review and approve regulatory documents in preparation for site activation• Develop and submit initial/updated central IRB applications and maintain communication with the IRB, as needed• Support CRAs in site start up and management activities• Supervise vendor activities



Genpact Pharmalink

• Sr Regulatory Affairs Associate

  • Jun 2015 - Dec 2017

  • Contributes to regulatory submission process for marketed vaccines/biologics• Author targeted sections eCTD with oversight of senior medical writer• Assist in the development of dossiers for product registration (BLA) and post-approval Chemistry, Manufacturing and Controls (CMC) submissions• Attend team meetings as necessary to support submission authoring projects • Contributes to regulatory submission process for marketed vaccines/biologics• Author targeted sections eCTD with oversight of senior medical writer• Assist in the development of dossiers for product registration (BLA) and post-approval Chemistry, Manufacturing and Controls (CMC) submissions• Attend team meetings as necessary to support submission authoring projects



IKARIA, Inc. - now a part of Mallinckrodt Pharmaceuticals.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• CRA

  • Feb 2015 - May 2015

  • Performed quality review of TMF in preparation for IND submission• Worked directly with clinical sites to obtain appropriate documentation as needed• Maintained status reports • Performed quality review of TMF in preparation for IND submission• Worked directly with clinical sites to obtain appropriate documentation as needed• Maintained status reports



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Specialist (Contractor)

  • Jul 2014 - Feb 2015

  Work with contract research organization (CRO) to coordinate preparation, submission and archiving of regulatory submissions for mega-study. Responsibilities include:• Coordinate preparation and submission of clinical trial applications and investigational new drug applications• Liaise with internal departments to obtain necessary documentation to complete regulatory submissions• Assure that appropriate foreign-language documents are translated• Organize, track and archive all regulatory documentation into appropriate internal regulatory



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Study Start-up Manager (Contractor)

  • Aug 2013 - Mar 2014

  CLINICAL STUDY START-UP SPECIALIST, THIRD-PARTY STUDIES (Oncology)Managed operational aspects of third-party study start-up activities for rare diseases and special research programs in compliance with all FDA, ICH/GCP guidelines  Acted as liaison between internal departments to coordinate timely execution of CDAs, ICFs, CTAs, and otherstudy start-up documentation Prepared clinical trial agreements (CTAs) for site review and negotiation Provided guidance to principal investigators and site personnel to facilitate third-party study processes Interfaced with community sites, site management organizations, and academic centers Facilitated resolution of program-level issues by proposing solutions to meet aggressive study start-uptimelines Maintained trial master files



LifeCell Corporation

• Project Manager, Investigator-Initiated Studies (Contractor)

  • Mar 2013 - Jun 2013

  PROJECT MANAGER, INVESTIGATOR-INITIATED STUDIES (Regenerative Tissue Matrix products)Under the direction of the chief medical officer, oversaw the operational aspects of the Innovative Studies and Investigational Support Program’s (ISIS) US/EMEA application process, with subsequent management of approved studies from initiation through successful data transfer to LifeCell and study result publication.  Set agendas, facilitated, and produced minutes for monthly ISIS Review Board meetings Worked closely with regional project managers and study sites to facilitate all ISIS processes Drafted, negotiated, and finalized CTAs Managed study-specific and departmental budgets and maintained budget dashboard Processed and monitored investigator payments in accordance with Sunshine Act provisions Interacted with investigators to facilitate proposal submission, protocol development, contract execution, study progression, data transfer, and publication Managed supply distribution to study sites (transferred and tracked study devices, products, and payments) Acted as liaison, with publication planning manager, to ensure outcomes were in line with dissemination targets



Durata Therapeutics

• Project Planner/Unblinded Clinical Supplies Associate (Contractor)

  • Aug 2011 - Mar 2013

  PROJECT PLANNER/UNBLINDED CLINICAL SUPPLIES ASSOCIATE (Infectious Disease)Integrated internal teams (eg, clinical operations, regulatory, manufacturing) to ensure that clinical and nonclinical supplies were distributed to clinical sites worldwide. Responsibilities included: Developing agenda and generating minutes for weekly study status meetings Creating and maintaining study timeline in MS Project Acting as liaison between CMC, Clinical Operations, Regulatory, and other departments Negotiating project change agreements and associated costs, as needed Managing vendors to ensure that study drug was appropriately packaged, labeled, released, allocated, and delivered to depots and sites worldwide Managing CROs to facilitate country regulatory approvals and import permits Developing CMC standard operating procedures and working practice documents Preparing pharmacy manual and other processes as a member of the Phase I study start-up team Generating queries to clinical sites based on data listing review for Phase III studies



Hoffman-LaRoche, Pharmaceuticals Division

• Global Studies Associate (Contractor)

  • Nov 2010 - Aug 2011

  GLOBAL STUDIES ASSOCIATE (Infectious Disease)Provided support to global study teams through all phases of clinical study management in accordance with appropriate quality standards, including ICH/GCP and applicable regulations. Responsibilities included: Participating in the review of vendor scope of work (eg, Perceptive/IxRS, Medidata/Rave), guidancedocuments, and manuals; coordinating defined tasks between vendor and study management team Negotiating project change agreements and associated costs, as needed Supporting planning and logistics for live and virtual investigator and study team meetings Developing study materials for physicians and patients (eg, informed consent flip chart, patient brochures) Managing vendor in development of fulfilment website for ordering and distributing study supplies; developedsystem training for country study managers, monitors, and administrators through group and individual WebEx sessions Coordinating EDC training for all site (eg, PI, Sub-I, clinical) staff and non-site (eg, Roche) personnel



Johnson & Johnson

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

• In-House CRA/Investigational Document Specialist (Contractor)

  • Aug 2008 - Nov 2010

  CLINICAL RESEARCH ASSISTANT/INVESTIGATIONAL DOCUMENT SPECIALIST (Cardiovascular, CNS) 04/10 – 11/10 and 08/08 – 09/09Successfully managed multiple studies in various stages of development. Worked with local trial managers, site managers, and study sites to obtain the regulatory documents necessary to complete FDA-compliant TMFs from feasibility/site selection through study start-up, closing, and archiving. Responsibilities included: Working closely with study team to select potential investigators and assess their interest in upcoming studies Preparing and distributing feasibility questionnaires, study binders, and other study materials Preparing confidential disclosure agreements and negotiating revisions within supplied guidelines Liaise with local and central Investigational Review Boards to ensure that site-specific informed consent forms were compliant with GCP/ICH/HIPPA guidelines Serving as primary regulatory contact to review essential documents to ensure compliance and accuracy from start-up through TMF reconciliation Tracking study progress in Clinical Trial Management System (CTMS) and resolving issues, as needed Maintaining and tracking study documents such as investigator brochures, insurance certificates, and INDsafety letters using Clinical Trial Safety Reporting Systems (CTSRS), CTMS, and other programs Importing and maintaining regulatory documents necessary for FDA submissions in GRIPS-Documentum Initiating, maintaining, and reconciling electronic and/or hard copy TMF



ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

• Biotechnology Research
• 200 - 300 Employee

• Clinical Trial Assisant

  • Sep 2009 - Apr 2010

  CLINICAL TRIAL ASSISTANT (Oncology)Worked with directors of clinical projects, clinical research associates, and research sites to coordinate, support, and execute clinical trials from feasibility/site selection through study start-up, conduct, closing, and archiving. Responsibilities included: Preparing and distributing study binders Reviewing essential documents and routing to appropriate department (eg, Regulatory Affairs) Initiating, maintaining, and reconciling electronic and/or hard copy trial master file Liaise with CROs contracted to provide international site monitoring services Communicating with sites regarding document updates and corrections; liaise with site managers on trial documents and study site readiness Tracking study enrollment and patient status through communication with sites Reviewing site monitoring reports for accuracy, completeness, and follow up Collecting and tracking clinical research forms and issuing site payments based on milestones achieved



Ingenix Pharmaceutical Services

• VP, Client Services

  • May 1997 - Jun 2003

  Responsible for all functional aspects of and productivity for a single-product, $2.6M account (50% meetings/50% publications); led a team of approximately 14 medical, program, and publications staff to successfully fulfill client contracts; maintained and expanded current level of contracted business; worked closely with medical staff to ensure all program content adhered to product life-cycle goals established by client; provided on-site client services for international programs.Accomplishments included increasing contract sales by over 100% in a one-year period; earning Employee Recognition Award for performance within the top 10% of the company; establishing client contracts in new therapeutic area; raising employee productivity to exceed company standards.



Projects In Knowledge, Inc.

• Project Director / Assistant VP, Program Services

  • May 1991 - May 1997

  VICE PRESIDENT, CLIENT SERVICES (CNS, Neurotoxin) (2002-2003)Responsible for all functional aspects of and productivity for a 2.5M single-product account (50% meetings/50% publications). Responsibilities included: Developing strategic marketing plans and negotiating final contracts for accounts in excess of $2M Leading a team of ~14 medical, program, and publications staff to successfully fulfill client contracts Maintaining and expanding current level of contracted business Working closely with medical staff to ensure all program content adhered to product life-cycle goals Providing on-site client services for international programs, including training sessions for field staffAccomplishments: Increased contract sales by more than 100% in a one-year period Earned Employee Recognition Award for performance within the top 10% of the company Raised team productivity to exceed company standardsACCOUNT SUPERVISOR / DIRECTOR (1999-2002)SENIOR PROGRAM DIRECTOR (1997-1998)