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Denise Veras

Independent Senior Clinical Research Consultant

Sr. Project Manager Oncology & Cell Therapeutics

Oakland, California, United States

Section title

Denise Veras's Email Addresses & Phone Numbers

Denise Veras's Work Experience

Freelance Consultant

Independent Senior Clinical Research Consultant

March 2017 to 2017

BioMarin Pharmaceutical Inc.

Sr. Manager, Development Science Clinical Operations

April 2014 to February 2017

San Rafael, CA

Cerexa

Clinical Program Manager C

February 2012 to February 2014

Oakland, CA

Denise Veras's Education

Penn State University

BS/BA, Administration of Justice, Sociology and Biology

1997 to 2001

About Denise Veras's Current Company

Freelance Consultant

About Denise Veras

📖 Summary

Independent Senior Clinical Research Consultant @ Freelance Consultant From March 2017 to 2017 (less than a year) Sr. Manager, Development Science Clinical Operations @ BioMarin Pharmaceutical Inc. From April 2014 to February 2017 (2 years 11 months) San Rafael, CAClinical Program Manager C @ Cerexa From February 2012 to February 2014 (2 years 1 month) Oakland, CASr. Consultant @ Portola Pharmaceuticals From September 2019 to April 2020 (8 months) Clinical Program Manager @ Five Prime Therapeutics, Inc. Manage a group of related clinical trials within the molecule portfolio program to drive communication on program timelines, budget, resources, clinical activities and priorities at the Clinical Development Team (CDT) Level.Ensure the implementation of quality parameters to proactively identify and mitigate program riskRepresent Clinical Operations on the Clinical Development Team (CDT); provide operational expertise and strategic input into the Clinical Development Plan (CDP) for assigned studies/program). Oversee program budget; ensure accurate and timely review monthly accruals and forecast budget variances.Develop and oversee study quality metrics within the programs and clinical operations departmentPartner with Clinical Operations Director to develop and implement operational strategy across the department and programs Participate in recruiting, hiring and training Clinical Operations staff. Effectively delegate activities and oversee Clinical Operation team deliverable. Manage a performance and development goals of CTM/CTA direct reports. Provide ongoing coach and mentoring.Lead and contribute to departmental process initiatives and projects as needed From December 2017 to March 2019 (1 year 4 months) South San FranciscoLead Sr. Clinical Trial Manager III, Onc Clinical Operations @ Exelixis Provide guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Partner with functional peers to manage, adjust, and revise project timelines/budgets Develop RFPs, select CROs/vendors, and manages external resourcesCommunicate project status and issues and ensure project team goals are met. Participate in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents. Contribute to development of abstracts, presentations, and manuscripts. Recruit, hire, mentor, and manage CPA/CRA direct reports and support their professional development. From November 2010 to February 2012 (1 year 4 months) Training Manager, Product Development Operations @ Genentech, A Member of the Roche Group Responsible for the management of training coordinators responsible for executing and maintaining global and site specific training programs Accountable for recommending changes to policies which effect area of responsibilityAssist training team in developing the overall training strategy and holistic training plans for global and local site implementation, including the go-forward support modelLead the establishment of local training curriculums to support role specific needsDeliver instructor-led training on a variety of topics and deploy department training initiatives Assists in selecting and overseeing the work of training consultants, contractors, and vendorsResponsible for managing Subject Matter Experts to lend support, provide direction, and identify skill and competency gaps within Clinical OperationsAccountable for the completion of comprehensive needs analysis to identify new skills or knowledge required and recommends training accordinglyLead per project initiatives to conduct research and analysis of initial training request to identify expectations, target audience(s) and deliverablesManage the development, maintenance, and finalization of training plans, timelines, and program budget projections, as requiredFunction as a liaison between business partners and end users to address training requests, needs and communications Modify existing training and training process documentation materials to reflect procedural and departmental changes Provided support and maintenance of a competency based training model and participate on process improvements and project teams From March 2008 to November 2010 (2 years 9 months) Training Specialist @ Genentech, Inc Responsible for managing Subject Matter Experts to lend support, provide direction, and identify skill and competency gaps within Clinical OperationsAccountable for the completion of comprehensive needs analysis to identify new skills or knowledge required and recommends training accordingly.Lead per project initiatives to conduct research and analysis of initial training request to identify expectations, target audience(s) and deliverablesManaged the development, maintenance, and finalization of training plans, timelines, and program budget projections, as requiredFunctioned as a liaison between business partners and end users to address training requests, needs and communications Modified existing training and training process documentation materials to reflect procedural and departmental changes Provided support and maintenance of a competency based training modelLeads and/or participated on process improvements and project teams Supported global and functional initiatives Responsible for the creation and revision Training Department proceduresPartnered with Instructional Designers to ensure the implementation of solid instructional design methodology to training program and materials From March 2008 to June 2009 (1 year 4 months) Clinical Trial Manager II @ BioOncology and Immunology, Tissue & Growth Repair Lead the Protocol Execution Team (PET) to ensure that trial timelines, costs, and quality metrics are met Serve as primary contact for functional area representatives in managing protocol executionEnsure accuracy and timeliness of vendor and site payments Oversee forecasting of clinical/non-clinical supplies Establish study milestones and ensures accurate tracking and reporting of study metricsManage trial-specific Genentech collaborations with other research entities (e.g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials) Perform ongoing vendor management (e.g., CROs, IVRS, Reading Centers, Patient Recruitment), including independent negotiation of scope of work, budgets, performance management, and issue resolution Create and manage clinical trial budgets and staffing/resourcing plans Provide study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate Provide support and mentoring to other Clinical Trial Managers Ensure trial adherence to ICH/GCP/local regulations Participate in clinical operations initiatives and programs as assignedDeveloped, managed, and executed patient recruitment plans and activities From September 2006 to March 2008 (1 year 7 months) Consultant Sr. Clinical Trial Manager @ Genentech, Inc Responsible for the development of operational plansSupervise and coordinate contract monitoring for optimal resource utilization.Monitor studies as required to ensure the quality of study conduct and the achievement of project milestones per the established timelinesIn collaboration with the Clinical Program Manager select and manage vendors (e.g., CROs, IVRS, Reading Centers, Central Labs, Patient Recruitment), develop and finalize study plans, which include but are not limited to: Study Monitoring Plans, Communication Plans, Study Quality Control Plans, Service Provider Oversight Plan, and the Trial Information Support Line Plan/Script Assist the Lead in the development of the IVRS specifications and perform User Acceptance Testing Accountable for site activities including site timelines, study visits, site selection, site initiation, site management, study drug management and closeout activities. Participates in study meetings (i.e. investigator/study coordinator/advisory board/sales). Site monitoring as project requiresCommunicates and provides accurate progress reports on assigned activities to study team. Responsible for managing vendor activities Develop, review, and approves regulatory and other required study documents for Good Clinical Practice complianceApplies fundamental knowledge of therapeutic area and drug development (investigational, observational, surveillance) to study plans From January 2006 to September 2006 (9 months) Project Manager, Clinical Research Computing Unit Project Operations and Compliance @ PENNSYLVANIA UNIV Responsible for project planning, tracking and management of the database development process for the conduct of clinical research studiesLead coordination activities between internal and external customers to identify project objectives, deliverables, resources, cost, and constraintsFacilitated the identification and management of all risks which either threaten the achievement of project objectives or had an adverse impact on the life cycle of project.Generated and reviewed study budgets in consultation with other coordinators, physicians and the business administratorLead a cross-functional team in the timely completion and execution of trial related activities to support research physicians working on NHI funded and industry sponsored research studiesLead the review and finalization of Case Report Forms, Study Aids, Manuals of Operations, and Study Progress ReportsWorked closely with office of Human Research to ensure the appropriate training of the project team as well as participating site personnelIn collaboration with the Director of Research managed the revision and implementation of SOPs Served as the main point of contact between Penn Principal Investigators and industry representatives Developed and managed the execution of investigator site contracts and budget negotiations in collaboration with department From December 2004 to January 2006 (1 year 2 months) Clinical Research Associate @ ASTRAZENECA, LP Served as an in-house monitor for Breast Cancer Trials to ensure that all processes are in compliance with the Code of Federal Regulations and Good Clinical Practices (GCP)/ International Conference for Harmonization (ICH) GuidelineProactively functioned as a part of the clinical study staff to help execute all study related procedures, which included but were not limited to: the collection, review and tracking of regulatory documents, the approval of Informed Consent Forms, development, collection, and tracking of Confidentiality Agreements and Site Contracts, the preparation and distribution of study start-up documentsCo-monitored and initiated investigational sites in collaboration with the Sr. Clinical Research Associates from the assigned Clinical Research Organization to ensure site compliance to study protocol and monitor proficiency. Site visits include all of the following visit types: pre study, qualification, interim, and closeoutExecuted the timely reporting of Serious Adverse Events to members of the Drug Safety Team and served as the lead CRA on the final reconciliation of SAE's reported to federal regulations (FDA/EMEA), those recorded at participating sites, and the Clinical Data Management SystemManaged and tracked the review of investigator site contracts, budgets and schedule of paymentsProvided support for the preparation of Clinical Study Reports and New Drug ApplicationsLed a global initiative for new trials under Global Clinical Development to ensure the proper handling and retention of Clinical Study DocumentsUnder the supervision of the Sr. Regulatory Affairs manager coordinated, developed, and finalized annual updates to regulatory authorities From January 2002 to December 2004 (3 years) Clinical Associate @ PREMIER RESEARCH OF SCP In accordance with GCP/ICH guidelines, functioned as an in-house monitor on multiple Central Nervous System and Cardiovascular trialsProactively identified study related issues and provided process development and improvement using advanced computer systemsFunctioned as a department resource for the training of new clinical research assistants with respect to the management of investigator files, the archival of clinical study agreements, preparation and distribution of study-start-up documents, and the planning of Investigator MeetingsIn collaboration with Project Manager, reviewed, revised and finalized clinical site contractsAccounted for the organization and maintenance of central files for assigned projects and communication with investigative sites, tracking the routing & collection of various project and regulatory documents, and the distribution of outstanding data queries to site monitors Successfully collected, reviewed, and tracked site regulatory documents, financial disclosure information, and clinical suppliesServed as a backup monitor to assist assigned Sr. Clinical Research Associates during study start-up and closeout From May 2001 to January 2002 (9 months) Pharmaceutical Research, Market Research Coordinator @ MARKET INSIGHT OF STATE COLLEGE Provided and conducted medical surveys for contracted pharmaceutical companiesFocused on the progress and efficacy of several treatments for medical dysfunctions in correlation with the pharmaceutical product undergoing researchRecruited qualified medical personnel for study participationTested the general comprehension of medical terminology and potential names for new pharmaceutical products From January 2001 to May 2001 (5 months) Administrative Assistant/Clinical Clerk @ COLUMBIA UNIV Provided accurate and effective administrative support to the head of the External and Community Affairs department Arranged, coordinated, and attended department activities on and offsite. In conjunction with the division lead, managed deadlines related to business planning as well as other special projects such as community out reach programs and clinics General office responsibilities included but were not limited to: scheduling and coordinating of staff onsite/offsite meetings, created and prepared presentation materials, assist with special projects Responsible for the filing and typing of important university documents which included but where not limited to: study protocols, Data Monitoring Committee plans and safety surveillance plans, regulatory documents, etc From January 1996 to December 1996 (1 year) Sr. Project Manager @ ICON plc San Francisco Bay Area


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Frequently Asked Questions about Denise Veras

What company does Denise Veras work for?

Denise Veras works for Freelance Consultant


What is Denise Veras's role at Freelance Consultant?

Denise Veras is Independent Senior Clinical Research Consultant


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Denise Veras's personal email address is d****[email protected]


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Denise Veras's phone (213) ***-*109


What industry does Denise Veras work in?

Denise Veras works in the Biotechnology industry.


Who are Denise Veras's colleagues?

Denise Veras's colleagues are Alithea Zetter, Abigael Chan, Greg Cantin, Helen Collins, Pauline Wong, Gloria Nam, Tina K., Marc Belsky, Nallakkan A., and Mohan Pokharel


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In a nutshell

Denise Veras's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

1 year(s), 5 month(s)

Denise Veras's Willingness to Change Jobs

Unlikely

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