Vote today for SCDM Board of Trustees
The 2009 election for new Board of Trustee members is now open.
The SCDM Board of Trustees provides strategic guidance and leadership to the organization. Trustees are volunteers that dedicate many hours to identifying and responding to industry trends, improving SCDM programs and creating new initiatives.
Participate in this important democratic process by casting your vote today. Polling closes August 21 at 11:59 p.m.
There are eight candidates vying for three open seats on the Board:
- Jeanne Ashton - Vice president, data management, PharmaNet Development Group
- Jennifer Duggan - Director of data management, AVIDYS INC
- John Estrada - Independent consultant
- Carol Garvey - Director, CDM, Genentech
- Thomas C. Grundstrom - Vice president, global data solutions, Quintiles
- Marysasser Hendrick Holloway - Senior director, ClinForce LLC
- Linda King - Manager, data science and solutions, Eli Lilly and Company
- Pat Stetser - Manager, Accenture
All terms run from January 2010 - December 2012.
Access complete candidate profiles and cast your vote in the Members Only section of the SCDM Web site.
If you need your member login and password, please contact us at info@scdm.org.
Election results will be announced at the annual business meeting, October 5, at the SCDM Annual Conference.
2009 Annual Conference
The SCDM Annual Conference is the premier educational event in the clinical data management industry. You won't want to miss out on this opportunity to sharpen your skills and meet new contacts.
Check out these photos from the 2008 conference to see what we mean.
And, as an SCDM member, you save $200 on full conference registration.
This year's event promises more exciting expert speakers, all leading sessions that delve into the most current topics in clinical data management.
We have also planned fun networking events, including the October 5 Data Driven Innovation Award reception at the Experience Music Project, an interactive music museum.
Need more convincing?
Here are three more reasons to attend the 2009 Annual Conference:
Annual FDA-SCDM Forum
9:45 a.m. Tuesday
A panel discussion led by representatives from the Food and Drug Administration. Learn how current and future regulations will affect clinical data management.
Defining Metrics
11:45 a.m. Tuesday
The Metrics Champion Consortium is developing standardized performance metrics. Discover how this will impact your job.
17 Hours of Education
Our courses are led by industry leaders, providing you with the most relevant and accurate information - and offering CEU credits. The 40 educational sessions offered this year were chosen from more than 220 submissions, ensuring quality, diverse options.
Additional information, including a preliminary program, can be found online.
For money-saving tips, be sure to read "Spending Less Green in the Emerald City."
We look forward to seeing you in Seattle!
SCDM Career Center is Hot Ticket in Cold Economy
We've all heard just how bad the job market is. Maybe you know someone who's lost his job. Maybe you've been affected personally.
Despite the layoffs, hiring freezes and budget cuts making headlines, there are still many job opportunities in clinical data management.
The SCDM Career Center is your connection to open positions in the industry.
Whether you're unemployed or just looking for your next opportunity, log on to careers.scdm.org to find your next job.
New jobs are posted every day, so visit often.
Make your job search easier with automated alerts
Never miss an opportunity again. Receive an e-mail automatically when new jobs are posted. You set the criteria - job title, or location.
Be proactive, post your resume
Use our anonymous service to post your resume and let employers come to you. Your credentials, experience and career objectives are visible to interested employers; your name and contact information aren't released until you approve.
Want to Create a Study Group for the CCDM® Exam?
Free webinar September 22 will show you how
A study group can help you and your colleagues prepare for the CCDM® exam. Joshua Cox and Grant Rempe from Quintiles will be sharing the secrets of their study group success during a 90-minute webinar, September 22 at 11 a.m. CDT. Josh and Grant helped two groups at Quintiles prepare for the CCDM® exam and they will describe how they formed groups that were engaged, sustainable and successful - all through creative facilitation techniques and resources that are readily available from the SCDM Web site.
Most people learn best by participating in groups that meet regularly and appeal to many learning styles.
Don't miss this opportunity to learn how you can do it too. A question and answer period will follow the presentation. Mark your calendar - more details to follow soon.
Online Learning...What's That?
Recently, we've received a number of questions related to online learning. SCDM's Director of Education, Sharon Kayne Chaplock, addresses one of them here.
Many professional development providers are coming out with "online learning" opportunities. What exactly does that term mean and what do SCDM's opportunities look like?
There are many programs being offered now under the "online learning" banner. This all-encompassing term, however, can refer to any educational offering that is supported by the Internet. Examples are courses delivered through webinars, webcasts, learning management systems and video conferencing. They are all accessed through a computer or sometimes even a mobile device.
SCDM has an established track record of online learning in the form of webinars, starting in 2006. This year, SCDM is going beyond the familiar 90-minute lecture/Q&A webinar sessions by adding four asynchronous online courses. The first, Data Management Plans, was offered this summer. It was hosted by Moodle, an open-source learning management system that provides a comprehensive learning experience. The response has been phenomenal, with 20 people enrolled and four on the waiting list from locations across the globe, including Russia, Kuala Lumpur, Mexico, Canada and the United States.
The asynchronous courses are interactive and instructor facilitated, offering an opportunity for a more in-depth learning experience than webinars and include real-world application of skills with peers and experts in the field of clinical data management. Learners are not required to be online at the same time and log in from anywhere at any time, allowing them to participate from their own backyards - as long as they have an internet connection. Learners must meet deadlines for assignments, unlike self-paced programs. Course structure includes an introduction and objectives for each week's module; resources for information content, including articles, videos, Web sites or narrated slide presentations; discussion forum postings; weekly assignments; and a final project. Students in the recent DMP course completed their final project in groups using a wiki.
SCDM's online courses allow a great amount of flexibility to satisfy course requirements: the opportunity to engage with colleagues all over the world, direct virtual contact with the instructor and the ability to earn continuing education units. A byproduct that students tell us they were not expecting is developing greater proficiency with computer-based learning tools that are transferable to the workplace, like performing more productive searches, participating in collaborative work using tools like wikis and developing communication skills through the discussion forum.
SCDM's online courses are filling up fast. Don't hesitate to sign up for any of the next three being offered this fall:
- Project Management for the Clinical Data Manager - September 7 through October 2
- CRF Design - October 12 through November 6
- CRF Tracking and Communication - November 10 through December 4
Go to http://portal.scdm.org/online-courses full course descriptions and registrations. Courses close after 20 enrollments and a waiting list will be started, or a new course opened up should there be enough interest.
SCDM Online Courses
Project Management for Clinical Data Managers
Enrollment is limited - Register today!
Dates
September 7 - October 2
Course Instructor
Josephine Scrofani, CPLP, vice president of training, eClinical Solutions, a division of Eliassen Group.
This course will deepen your knowledge of project management concepts and tools, and put this knowledge into practice during course exercises. You are encouraged to use a work-related clinical project or trial for course assignments that can have immediate application to your job. Key topics include the Triple Constraints, the PM Life Cycle and the Nine Knowledge Areas. The course also includes how to successfully manage projects with remote and virtual teams.
For further information and to register click here: http://portal.scdm.org/?q=node/290
CRF Design Online Course
CRF Design for Data Managers Online Course Starts October 12
This asynchronous online course has been designed for anyone directly involved in EDC or paper case report form design, review, development, distribution and archiving for clinical trials. It assumes that student have some basic clinical research knowledge. The course will provide a more expert level of detail in designing case report forms. Students will also gain practical experience in applying what they learn.
Over four weeks, the course will address general principals, best practices, issues to consider for EDC vs. paper, international trials and standards, and relationship to database structures in all phases of clinical trials.
At the conclusion of the course, learners will be able to:
- Describe the importance of a well designed CRF including considerations related to database structure, content, layout and clinical site locations.
- Explain the impact of CDASH and SDTM on CRF design.
- Design, revise and finalize CRFs according to the study protocol and client specifications while adhering to best practices for CRF design.
- Author essential supporting documentation for CRFs, including Completion Guidelines and Data Entry Guidelines.
- List and implement data governance procedures for a Case Report Form standard library.
2009 Webinar Schedule
For more information and registration, please click on the webinar title below.
| Date | Title | Sequence |
| August 22 | Study Group 101 | Certification Sequence |
| September 10 & 17 | Database Validation and Surviving an Audit | Certification Sequence |
| October 22 & 29 | Patient Reported Outcomes | Career Development Sequence |
| November 5, 12 & 19 | Project Management Toolbox | Certification Sequence |
* Please read our updated Webinar Terms and Conditions
Archived Webinars
- Clinical Trials Abroad
- Data Acquisition
- Data Management & Oncology Trials
- From CDASH to SDTM Data Sets - Putting CDISC Standards to Work for You!
- Overview of Emerging and Established Standards
- Trends Shaping Clinical Data Management
For more information and to purchase these webinars please click here: http://www.scdm.org/events/webinars/archive/
Volunteer Opportunities
SCDM encourages members to become actively involved in the organization. Volunteering is an excellent way to advance your professional development and broaden your network of professional colleagues.
Click on the taskforce listed for a detailed description of volunteer opportunities.
Products and Services Committee
Education and Professional Development
Marketing and Communications
If you would like to volunteer, please contact volunteers@scdm.org.
SME's Wanted
WANTED! Short-Term SCDM-GCDMP Volunteers:
Subject Matter Experts needed to review the next Good Clinical Data Management Practices (GCDMP) chapters scheduled for revision.
SCDM is looking for three to five Subject Matter Experts (SME's) to work on the following chapters: Systems Validation/Systems Auditing and External Data Transfers.
Requirements for SME's include:
- Three to five years of direct experience with the topic at an expert level
- Good communication skills and a good command of the English language
- Ready access to necessary authorities or resources to confirm accuracy or compliance of content according to governmental or regulatory agencies or other authoritative bodies and guidance
- Must have the available time needed to serve in the capacity of SME, estimated to be approximately 30 to 40 hours over the course of the assignment
Work will begin as soon as SME's are identified and continue until chapters are complete - approximately two to three months.
If you are interested in becoming a Subject Matter Expert for any of these chapters, please send your qualifications, CV and the chapter(s) you are interested in to Sharon Kayne Chaplock at schaplock@scdm.org.
CCDM® Industry Rewards Program
The CCDM® Industry Rewards Program is now closed for 2009. Watch for updates this fall on the 2010 program.
SCDM rewards the following companies for their commitment to excellence through their support of the CCDM® program:
Industry Master — 100% of CDMs are CCDM®s
- Cleveland Clinic Vascular Surgery Academic Coordinating Center
- McDougall Scientific Ltd.
- ClinForce LLC
- Kestrel Consultants, Inc.
- Tolerx
- Shannon Labout, CCDM
Industry Champion — 50% of CDMs are CCDM®s
- Cetero Research
Industry Leader — 25% of CDMs are CCDM®s
- Covidien
- Duke Clinical Research Institute
- Enzon Pharmaceuticals, Inc.
- Innovative Analytics
- BioClinica, Inc.
- ResearchPoint
Partner Level — 10% of CDMs are CCDM®s
- Roxaane Research Limited
- PharmaNet Development Group
SCDM Board of Trustees Update
The Board of Trustees met in our offices in Milwaukee, Wisconsin, July 16 and 17. As part of our restructuring earlier this year, we formed a Finance Committee which met prior to the board meeting with the accountant. In this current economic environment, we are carefully monitoring the financial status of this organization and making appropriate decisions based on the information.
We engaged in a status update on our three year plan which we felt is on target at this time. In addition, we began discussing our longer term goals in advance of our October meeting.
We had our regular teleconference with the Committee Chairs. It was exciting to hear about all of the work that is being done by the committees and taskforces and the engagement of our volunteers. Membership is holding steady. The Annual Conference pre-registration is consistent with last year. Certification is doing well with SCDM celebrating the 400th person certified. SCDM is staying up to date by utilizing electronic media. We are on Facebook and Twitter and have connections through LinkedIn. Please visit us there. Our educational opportunities are expanding between our conferences, online learning program and our webinars. Our GCDMP is constantly being updated and new chapters are being written. Articles are being shared in Data Basics. There is also a Strategic Directions Committee that seeks out early information on industry trends so we can adjust our planning and goals.
SCDM has a wide range of new candidates for the Board of Trustees' three open positions. Voting begins today and I am sure we will all have tough decisions to make with the excellent candidate pool.
All in all, very exciting times for SCDM and hopefully for you.
Susan K. Howard, Trustee SCDM
Therapeutic Program Manager
Oncology Data Management
GlaxoSmithKline
Members in the News
Making Waves
SCDM Member News
Jonathan Andrus, CCDM, will be presenting the EDC/ePRO Tutorial along with Bryan McDowell at the 3rd Annual Clinical Forum in Nice, France, October 19-21 at the Nice Acropolis Congress Centre.
Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to Sue Abrahms at sabrahms@scdm.org.
Get to Know the CCDM®
SCDM is proud to introduce Erika T. Miller, CCDM, as a recipient of the Certified Clinical Data Manager designation. Erika is a certified pharmacy technician with i3 Statprobe in Indianapolis, IN.
| Q: | Why did you become certified? |
| A: | I became a CCDM® to challenge myself professionally and intellectually as well as make myself marketable in a highly competitive industry.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | The challenges I faced studying were making time outside of work to prepare for the exam and reviewing the GCDMP in its entirety. The challenges I had taking the exam were making sure I read and understood all of the questions and answers. And not over thinking my responses when answering the test questions. |
| Q: | How has being certified benefited you? |
| A: | It has given me more confidence at work and when applying for other positions. |
| Q: | What materials did you use to study for the exam? |
| A: |
SCDM GCDMP; ICH Guidelines; Guidance for Industry Computerized Systems Used in Clinical Trials; Guidance for Industry Part II, Electronic Records; Electronic Signature - Scope and Application |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Study focus group will be a good idea to get you familiarized with all competency areas listed for the exam. Also doing extra research studies in those areas where your day-to-day job activities do not revolve around, will contribute to your success on the exam. |
| Q: | Any additional comments you would like to provide? |
| A: |
When taking the exam, take your time and relate each question back to the GCDMP document. |
SCDM welcomed these NEW members in June 2009!
|
Leslie Armstrong Toni Avery Ramona Bosley Julie Brothers Amanda Brown Anton Grunberg David Carlin Jaime Ceja Christoph Coch Nel Collado Melissa Collins Britt Cruz Teresa DeVincentis Michele Ehlman Nicole Fayuler Kisha Fong Yee Stephanie Gallaway-Young Lorna Gillepie Thomas Grundstrom Agneta Hedlund Victoria Holloway Xiaoming Hou Margaret Hurley Olgica Huskic |
Mindy Isaacs Elizabeth Jennings Karen Jones Wendy Joyner Leon Kalbfleisch Jun Kim Lisa Kleinkopf Xiaomei Liu Jamie Lindeman Laura Lundy Laura Mann Mark Marchan Cindy Martin Anna Mattsson Elizabeth McCormick John McGettrick Rajeev Naithani Venkatesh Nathilvar Motohide Nishi Gail OBrien Henrik Olsson KT Oxford Tina Pagos Ryan Palmer |
Gregory Pavlov Anthony Pellegrino Teneisha Podczervinski Harish Rajamannar Cherry Rallonza Ryad Ramda Anne Robakowski Susan Schwarzwalder Chris Scott Laura Seward April Shubert Phillipa Smith Lisa Smotherman Jeff Sonas Cornelia Spiekermann Margarita Strand Brendan Townley Jennifer Tran Brian Vidal Fang Wang Michael Williams Sara Yopp Ji Yu |
SCDM congratulates the following member for entering
her 5th year of membership in June 2009!
Elisa Priest
