Experience

Transcenta
• China
• Biotechnology Research
• 1 - 100 Employee
• Director Clinical Trial Management

  • May 2022 - Present

Covance
• United States
• Research Services
• 700 & Above Employee
• Project Director

  • Apr 2020 - May 2022

Syneos Health (Previously INC Research/inVentiv Health)
• Associate Project Director

  • Mar 2018 - Apr 2020


PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Senior Project Manager

  • Sep 2015 - Mar 2018

  The Project Manager (PM) is responsible for owning and achieving interim and final contractual deliverables for assigned projects/programs, according to the time, quality/scope and cost constraints. • The PM leads and directs cross-functional teams, understands and manages client expectations/ needs to achieve client satisfaction. • The PM proactively identifies, resolves/mitigates and escalates risks and/or issues. The PM adheres to PRA standard procedures and processes. • The senior PM may act as lead project manager in international projects. Consequently, the senior PM may provide oversight to other members of the project management group.



Quintiles

• Spain

• Senior Clinical Project Manager

  • Nov 2014 - Sep 2015

  • Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to. • Report on team performance against contract, customer expectations,and project baselines to management. • Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk. • Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. • Provide input for the development of proposals for new work and project budgets. • Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs. • Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team. • Prepare and present project information at internal and external meetings. • Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff. • Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans.



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Manager II

  • Mar 2012 - Nov 2014

  Provides customer-focused leadership in managing clinical trials across various phases and functional areas and assigned clinical staff. Accountable for the successful execution of all assigned projects, where success includes ontime, on-budget, high quality/compliant project results that lead to satisfied customers. Acts as an integral part of the selling team through involvement in proposal development and bid defense. Serves as the primary liaison with Customers, vendors, and Investigator Sites. May have line management responsibility for assigned clinical staff. Manages projects from proposal development to final deliverables to the customer ranging in size and complexity from single service studies to full scope, multiple protocol projects, which may be global, with limited interaction from supervisor.

• Project Leader, Regulatory Consulting and Submissions

  • Jun 2009 - May 2012

  The Regulatory Consultant/Project Leader position is for associates with technical expertise and strong organizational and management skills. Regulatory Project Leaders are responsible for the day to day running of a team of regulatory personnel, and also leadership of major assignments and client relationships. Regulatory Project Leaders will be responsible for the quality and timeliness of the assignments being generated by their teams. In this position they are responsible for providing advice and assistance to clients and other Kendle associates in their areas of expertise. They are also responsible for contributing to regulatory consulting work for North America, including INDs, NDAs, and CTA submissions for Canada.

• Project Leader

  • Jun 2007 - Jun 2009

  Provided customer-focused leadership in managing multiple Phase I through Phase IV clinical research trials across functional areas, both US and globally. Was accountable for the successful completion of all assigned projects, where success includes all of the following: on-time, on-budget, in compliance with all applicable regulations, quality data and reports, and satisfied customer. Worked with and managed team from multiple departments such as medical writing, site selection, regulatory, clinical monitoring, clinical data management, biostatistics, IVRS, meeting planning, and document management. This position was also accountable for proposal development and bid defenses for assigned RFPs and functioned as an integral part of the selling team. Participated in multiple bid defenses with successful outcomes including new awards for Kendle. Was administratively responsible for assigned clinical staff. Managed at one time a total of 8 CRAs, including Senior and LCRAs, and 2 Project Assistants.

• Medical Editor

  • Feb 2004 - Jun 2007

  Led and assisted in writing and formatting of clinical study reports, protocols, IND submissions or other documents produced by the Medical Writing group and as needed for those documents produced by the Scientific Events, Education, & Publication group. Edited existing manuscripts to give maximum clarity of meaning, accuracy, relevance, and consistency of style and format to ensure that client objectives were met and overall quality standards were maintained. Provided assistance in quality control (QC) of clinical study reports. Assisted in assembly and QC of report appendices. Maintained awareness of budget specifications for all assigned projects. Worked with contacts (Kendle IT and sponsor) to trouble-shoot problems with templates that were provided by the sponsor. Served as primary document holder and editor for reports or IND submissions being written by multiple writers. Completed three IND submissions, one of which was a sponsor/investigator IND, created the Kendle Clinical Study Report Template in use by the department, wrote protocols and assisted in the writing of clinical study reports, moving more from an editorial role to a writing role. Also produced newsletters for specific studies, wrote safety narratives, and wrote a number of informed consent forms.

• Text Specialist

  • Aug 2003 - Feb 2004

  Reviewed selected Requests for Proposals (RFPs) from clients and developed customized text proposals. Worked with New Business Development Managers and Proposal Analysts to create accurate, professional, client-specific text and tables that appropriately conveyed Kendle's services and image. Proofread and edited proposal text prior to submission to clients. Along with Project Leaders and operational team members, created clear, organized, effectual proposal text consistent with services and specifications outlined in RFP and fee estimate. Clearly communicated via written text Kendle's services and project plans. Developed, maintained and revised standard proposal templates as well as customized client versions. Created the Phase IV template of proposals used by the Sales department. Participated in training of Text Associates in regards to proposal text format, standards and client-specific requirements. Ensured accuracy and consistency of CV styles contained within the CV Repository. Trained in use of the Global Pricing Model where all fee estimates are calculated.

• Regulatory Specialist

  • Nov 2000 - Aug 2003

  Responsible for obtaining completed Regulatory and other Sponsor required documents from potential investigators for study start-up, verifying the accuracy and completeness of the documents, and aiding in site identification and selection. Involved daily communication with both Sponsors and sites. Also responsible for instructing the investigational site and Kendle personnel on regulatory requirements and responding to questions from investigational sites and Kendle personnel regarding regulatory issues. Fully versed in ICH/GCP Guidelines. Responsible for IRB submissions and informed consent review. Experienced in providing presentations at Investigator Meetings to further instruct site personnel on regulatory requirements. Have led teams of specialists within Kendle for large scale projects and have handled multiple studies during peak times.

• Regulatory Assistant

  • Jan 2000 - Nov 2000

  Responsible for effectively and efficiently providing support for the collection, copying, cataloging, and filing of study-specific documents, following Central File operative rules. Also responsible for updating regulatory spreadsheets and contacting investigational sites in order to keep documents updated and regulatory compliant. Required establishing close working relationships with other departments, such as Project Management and Clinical Monitoring.



Northern Kentucky University

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Professor

  • Jun 2004 - Jun 2006

  Responsible for teaching the English Composition sequence and Business Writing. Courses involved teaching introductory composition, developing research papers, and all forms of written business communication, including basic web page design. Required developing own curriculum. Responsible for teaching the English Composition sequence and Business Writing. Courses involved teaching introductory composition, developing research papers, and all forms of written business communication, including basic web page design. Required developing own curriculum.



University of Cincinnati

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Professor

  • Sep 2003 - Jun 2005

  Responsible for teaching the English Composition sequence at the Raymond Walters college branch of the university, involving courses about introductory composition, developing research papers, and writing about literature. Required developing own curriculum for Raymond Walters largely non-traditional student base, including older, returning students, students with families and full-time jobs, and English as a Second Language (ESL) students. Responsible for teaching the English Composition sequence at the Raymond Walters college branch of the university, involving courses about introductory composition, developing research papers, and writing about literature. Required developing own curriculum for Raymond Walters largely non-traditional student base, including older, returning students, students with families and full-time jobs, and English as a Second Language (ESL) students.

• Teaching Assistant

  • Sep 2001 - Jun 2003

  Full responsibilities of adjunct professor in English Composition sequence, while learning theories and practices of teaching. Full responsibilities of adjunct professor in English Composition sequence, while learning theories and practices of teaching.

• Associate Editor for Licking River Review

  • Sep 1997 - Jun 1998

  Responsible for choosing fiction, poetry, and drama for national literary magazine, from cataloguing submissions as they arrived, to final. Also responsible for editing the submissions and layout and had final say, along with Editor, for acceptance. Supervised all subordinate editors, such as the Fiction Editor, and all assistant editors. Required extreme eye for detail and editing skills. Also Fiction Editor 1996-1997 and Assistant Editor 1995-1996. Responsible for choosing fiction, poetry, and drama for national literary magazine, from cataloguing submissions as they arrived, to final. Also responsible for editing the submissions and layout and had final say, along with Editor, for acceptance. Supervised all subordinate editors, such as the Fiction Editor, and all assistant editors. Required extreme eye for detail and editing skills. Also Fiction Editor 1996-1997 and Assistant Editor 1995-1996.