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Clinical Training Forum 2010 - Day 2

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Tuesday, October 5, 2010

7:15 am Sponsored Breakfast (Opportunity Available, Contact Arnie Wolfson: 781-972-5431, or Morning Coffee

8:00 Chairperson’s Day Two Welcome



8:05 The Selection, Care, and Feeding of Subject Matter Expert Trainers

Barbara van der SchaileBarbara van der Schalie, Clinical Training Manager, Clinical Research Directorate, SAIC-Frederick

The scrutiny of the quality, accuracy, and effectiveness of training for clinical research professionals by the FDA is increasing. For this reason, utilizing subject matter experts (SMEs) is a best practice. To optimize the learning experience, SMEs must be prepared to engage their audience, understand the adult learning process, and appropriately evaluate knowledge and skill transfer, which may not be part of their clinical research preparation. As the clinical research enterprise rapidly expands and diversifies, and training budgets contract, the need to identify qualified subject matter experts to provide focused, accountable training and maintain their qualification increases. The session will explore the optimal profile of a potential subject matter expert training collaborator. It will also suggest a curriculum for their qualification as a trainer and for maintaining their training credentials.



8:50 Strategies for Training Virtual Teams

Kathy Donato, Senior Training Manager, Johnson & Johnson Pharmaceutical R&D

In this session, we will explore strategies for effectively and efficiently conducting global clinical research in a virtual world. The focus will be on identifying the factors that a virtual team needs to manage the complexities and challenges that exist globally to reach across time, distance, and culture. In order for a virtual team to succeed, leaders and members must understand the dynamics of the virtual team structure, make the most of interrelationships, and implement effective technology. In this session, we will:

  • Explore the structure, complexities, and challenges of virtual teams
  • Explore the realities and debunk the myths of virtual team communities
  • Describe how virtual teams build foundations through team structure, team interrelationships, and technology

9:35 Maximizing Training Resources in Global Environments

Sharon FernandesSharon L. Fernandes, Associate Director, Clinical Operations Training & Communications, Shire Pharmaceuticals

Shire is a small pharmaceutical company with headquarters in the US and UK. Clinical Development’s Training & Communications department serves over 330 people located in the Wayne, PA, and Basingstoke, England offices. The growth of Shire’s smaller local operating companies in Australia, Canada, France, Germany, Italy, the Netherlands, Spain, and soon to open Switzerland, has forced us to reconsider the interactions we have with our client base. While instructor-led classroom training is the gold standard, travel & budget restrictions prohibit instructors from traveling to all locations – especially since our attendance numbers are relatively small. The presentation will highlight the following:

  • Shire’s global model
  • Global New Hire Orientation
  • How we utilize videoconference, teleconference, and Live Meeting to provide training and more
  • Best practices and lessons learned

10:20 Networking Coffee Break and Exhibit Viewing



10:40 Helping Your Senior Leadership Champion High
Impact Training

Mark MedlinMark Medlin, Manager, Education and Training, Project Office, Duke Clinical Research Institute

Training managers can educate their organization’s leadership on: how much to budget for training, how to move training from focusing on “check the box” to focusing on strategic advantage, and how to structure training to get bigger impact. Many clinical operations managers who are responsible for training don’t have experience or information about industry benchmarks on training budgets and spending or on the role of training in organizational excellence. This presentation quickly pulls together several key pieces: training budgets, three organizational roles of training, and structures that support high impact training, that professionals can use immediately to improve their organization’s training

  • What companies should spend on training and how they should spend it
  • Understand the three key roles of training in an organization
  • How to design learning experiences that result in better measurable impact

11:25 Right from the Start: On-Boarding using Clinical Research Role Specific Training

Susan LoomisSusan Loomis, Clinical Training Manager, Clinical Operations, Takeda Global Research and Development Center, Inc.

Very few companies provide the necessary role training to new personnel to help them to succeed. This presentation would explain the necessity of providing a comprehensive on-boarding program. A comprehensive on-boarding program provides the new hire with department insight, expectations, and role development. A comprehensive on-boarding program ensures new personnel perform in minimal time. The presentation will provide details to ensure attendees walk away motivated and have the tools to create an on-boarding or move their existing program to the next level. Attendees will learn:

  • The various segments used to create a comprehensive on-boarding program
  • The importance of role focused training
  • The importance of performance support (OJT)

12:10 pm Sponsored Luncheon (Opportunity Available, Contact Arnie Wolfson: 781-972-5431, or Lunch on Your Own



1:25 Strategies for Developing Engaging GCP Training

Denise FinleyDenise Finley, Director, Clinical Learning and Development, Boston Scientific

Challenged by employees who think they know all there is to know about Good Clinical Practice? Are you able to present undisputable evidence that your employees are adequately trained in the area of Good Clinical Practice? Do your employees embrace the opportunity to engage in Good Clinical Practice training and provocative discussions? Working in a highly regulated environment such as pharmaceuticals and medical devices warrants meticulous attention to the design, development, and deployment of training opportunities for employees. Employee engagement and attitude is one of the most important factors in ensuring adoption of training requirements. This session will offer some “food for thought” in making what can be considered a “boring” “I already know this” training session into an interactive learning opportunity for both sponsor employees and site personnel.

  • Employee engagement and attitude is key to successful training
  • Being well-trained in GCP is essential to the conduct of Clinical Research
  • Training sessions should be interactive learning experiences




2:10 Strategies for Designing Engaging and Memorable Clinical Training In-house Using Articulate Software

Shawn AndrewsShawn Andrews, M.B.A., Training Manager, Global Medical Affairs, Allergan

In today’s environment, pharmaceutical training organizations are increasingly faced with the need to develop e-Learning to meet the demands of their clinical teams, both in the U.S. and globally. At the same time, budgets and headcount have been significantly reduced. However, most trainers do not have backgrounds or skill sets as programmers, developers, or instructional designers. The good news is…you don’t have to! Using Articulate, participants will be equipped with the knowledge and power necessary to create and develop compelling e-Learning curriculums with tremendous savings to your organization, without the help of outside vendors. As a bonus, participants will learn a proven approach/best practice in recording Voice-Over presentations using the Subject Matter Experts in your organization, with no technical background required.

  • Develop engaging clinical e-Learning curriculums – while keeping Adult Learning Principles in mind
  • Understand the capabilities and ease of use of Articulate Studio (Presenter, Quizmaker, Engage, Video Encoder)
  • Create Voice-Over narrations of existing PowerPoint decks using in-house resources/subject matter experts
  • Demonstrate significant cost-savings (ROI) back to your organization

3:10 Networking Refreshment Break and Exhibit Viewing



3:30 Case Study: US Clinical Researcher of the Year

Joanne GodmanJoanne Godman, Director, Training & Communications, Shire Pharmaceuticals

The US Clinical Researcher of the Year competition is the first initiative of its kind to provide a platform for Clinical Researchers in the US to demonstrate their abilities through a competency-based program devised by a cross-industry Executive Steering Committee of senior Clinical Directors and Leaders. The competition’s aim is to raise the profile and importance of Clinical Research in the US against increasing competition for global clinical trials by championing the talents of the best researchers. In the first major collaborative exercise of its kind, Senior Executives from J&J, GSK, AZ, Sanofi Aventis, Shire, i3, and Chiltern developed a program to benchmark clinical competencies for CRAs, Project Managers, and Study Coordinators working at the sites and the winners were announced in Philadelphia in April. This presentation will highlight the following:

  • US Clinical Researcher of the Year Competition – What is it and who is it for?
  • US Clinical Researcher of the Year Competition – What does it entail?
  • US Clinical Researcher of the Year Competition – What are the benefits
    to you?
  • US Clinical Researcher of the Year Competition – How can you participate?

4:00 Moving from Investigator “Meetings” Toward Investigator “Training”

Manfred StapffManfred Stapff, M.D., Ph.D., Senior Director, Clinical Development, Forest Research Institute

According to GCP it is the responsibility of the sponsor of a clinical trial to ensure that all investigators of a multicentre trial conduct the study in compliance with the protocol, that they are given instructions on following the protocol, and that communication between investigators is facilitated. These training activities might be a subject of on-site inspection by auditors and/or agencies. Investigator meetings are critical since they usually are the first or important contact between site staff and sponsor beyond preceding site selection visits. To ensure proper conduct of the study and to use invested costs efficiently, investigator meetings must be planned and conducted in the most professional way, and must not be seen as a boring pre-study routine. While cost constraints urge sponsors to find alternative and more cost efficient formats for investigator training, advances in technologies allow new ways of communication with investigators. Decisions about meeting format and content should be based on reasonable grounds like actual needs and training objectives, rather than financial or technological reasons alone. During this session, attendees will hear steps to be followed for planning, coordinating, executing, and leading face-to face-investigator meetings or alternative formats to train site staff in knowledge or skills necessary to successfully conduct a clinical study.

  • Learn how to identify the study specific training needs
  • Know how to decide about the best site training format and platform
  • Hear how to optimally plan for, and execute, an investigator meeting

4:45 Wrap-Up and Close of Conference


Naila Ganatra, General Manager, Barnett International (215) 413-2471 or

Rachel Meyers, Associate Director, Barnett International (413) 527-3056 or 

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