Penn State University

Villanova University

Penn State Great Valley

Director Clinical Data Management Systems at Exelixis

San Francisco Bay Area

Exelixis

Director Clinical Data Management Systems

Associate Director, Clinical Data Management Systems

Chiltern

Associate Director, Clinical Analytics

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MiFitnessHub

Co Founder

- Member of leadership team that participates in defining department initiatives.•	Member of management team that oversees internal initiatives to define roles,          responsibilities, and career paths for the department.•	Overall project lead with cross functional teams that supported integrations of clinical          systems such as Safety, IXR, and CTMS.•	Manage and participate in vendor selection (RPF,RFI), resourcing and budgeting.•	Work directly and manage vendor partnerships used for data management and/or EDC          programming.•	Establish and negotiate timelines with internal and external team members for completion         of activities for cross functional projects.•	Hire and onboard new staff members.•	Manage internal and offshore teams and conduct annual reviews and status meetings.

Onyx Pharmaceuticals

Sr. Manager, CDM Systems

Manager, EDC Operations

- Partnered with supervisor in developing infrastructure of the EDC Programming         environment; and process improvement.•	Developed and implemented  a quality testing department to deliver quality study builds.•	Responsible for the timeline and quality of EDC Programming deliverables.•	Responsible for execution of ad hoc requests, and other reports as required.•	Ensure documentation and archival of clinical programming deliverables including CDM         systems, databases, programs, and specifications.•	Performed project management for programming resources, quality testing resources and         study support activities. •	Applied and promoted consistent programming standards through standard processes and         SOPs.•	Identified areas of deficiency requiring SOPs or guidelines and executed a plan to rectify.•	Followed guidelines and specifications on validation procedures and data transfer         procedures. Maintain appropriate documentation surrounding maintaining or archiving         clinical data and/or programs.

Theorem Clinical Research

Manager, Clinical Programming

- Provide ongoing programming and  technical support during study conduct including  managing       study database changes/amendments, ad- hoc reporting, design and development of eCRFs      and edit checks.● Provide technical support during UAT  including authoring documentation, test scripts and    execution.● Program Phase I, II and III studies with for various indications.● Review and update project specifications and documentations.● Mentor new team members on internal and client process. ● Work with Business Objects to create various study specific reports.● Adhere to CDISC standards for study development.

Sr. Clinical Programmer

- Certified Rave Study Builder and Study Administrator•	Developed Rave Global Libraries of Standard Forms and Edit Checks• 	Prepare and Provide Technical Demonstrations and Presentations of           the different solutions in the Product Suite Specifically Rave and          Various Rave Modules•	In-depth knowledge of Rave EDC system development and         configuration for various Therapeutic Areas and Phases of Study•	Adhered to CDISC standards with a focus on the ODM and CDASH         Forms for study execution and study design•	 Work closely with Sales Representatives and Sales Teams to build           relationships with clients and understand their business to provide           the best solutions to meet their current and future needs•	 In-depth knowledge of the overall value of eClinical solutions in all          phases of the clinical trial process and working experience with Trial          Planning, Trial Design, and Trial Execution

Medidata Solutions

Business Consultant

- Build and maintain demonstration instances of the product suite, including customized solutions   for specific customer interest/need (e.g. - CRFs, workflow, and integration examples).• Provide presentations/demonstrations that articulate the superiority of the OMCM EDC solution   Maintain a preview instance(s) of the TrialMaster suite for customer use during the sales cycle,   including setting up new user accounts and providing navigational training.• Actively maintain a depth of expertise/knowledge of the product suite, including    technical/functional changes and new features.

OmniComm Systems

Solutions Consultant

- Manage Rave EDC Projects related to the support and operation of the Rave EDC application   and associated Integrations such as Safety Reporting, Medical Coding and IVRS.• Conduct the project testing of Rave Studies and validation adhering to SOPs, Quality Assurance   and regulatory requirements related to the integrations applications.• Define Rave EDC system objectives and specifications in collaboration with clinical project    manager and statistical programmer.• Maintain the Rave system core configuration and documentation regarding enhancements and   User Acceptance Testing documentation associated with integrations and study close out   procedures.• Set timelines for specific tasks during project development and allocate resources to complete    tasks. • Liaison between system programmers and project teams to incorporate and define functionality   in Rave EDC application.

Genentech

Systems Analyst/Project Manager

- Managed the project team’s activities in order to ensure quality, accuracy and the timely delivery of project to clients.•Gathered the requirements and wrote the system specifications and oversaw the development of individual projects in accordance with the client needs.•Estimated duration of tasks for different phases of development while managing the complexity of the tasks and project budgets.•Guided the client to successful use of the IVRS by assisting with any problems or questions they may have throughout the study development.•Supervised the project testing and validation for quality control adhering to SOPs, Quality System and regulatory requirements.•Traveled to client sites and investigator meetings for presentations and/or training on the Clinphone product.

ClinPhone

Clinical Project Manager

- Preformed multifaceted programming and analysis for full-cycle software development and implementation.•Gathered requirements for and programmed electronic Case Report Forms, system edit checks and custom edit checks for Electronic Data Capture Applications on a project basis.•Worked with Quality Control for all Electronic Data Capture application projects.•Assisted in the development of Electronic Data Capture applications for clinical studies to ensure quality, accuracy and timely delivery of projects.•Mentored and trained entry-level members of the team and was lead to troubleshoot application issues.

Vicken Yanikian

Vicken Yanikian