2009 SCDM Annual Conference Don't Let Procrastination Cost You: Early Registration Discounts end July 17
Please join us for the clinical data management industry's premier education event, the 2009 SCDM Annual Conference, October 4-6 in Seattle, WA.
A registration form and preliminary program are now available online.
This year's meeting will provide CDM professionals of all levels with exceptional professional development opportunities. Our schedule of educational sessions is divided into two tracks, so you can attend the presentations that are of most interest and most relevance to your work responsibilities.
Two exciting keynote speakers will share years of experience and insider tips to help you add value to your company and improve your work performance:
- Diane Jorkasky, former Pfizer executive, discusses the importance of leadership in clinical data management
- "Productivity Pro" Laura Stack, a professional speaker and time-management expert, will provide strategies for increasing productivity at your workplace.
Our second annual SCDM-FDA Forum will update conference attendees on the latest government initiatives and regulations impacting clinical data management.
Be sure to attend session VIA, where a representative of the Metrics Champion Consortium will share the MCC's initiatives to standardize data measurement.
And you won't want to miss the Data Driven Innovation Award reception at the Experience Music Project, an interactive music museum. The Data Driven Award honors the best advancements in clinical data management technology or service. Submit your entry online through July 24.
If your company hasn't signed on as a sponsor or exhibitor yet, there are still limited opportunities available. Contact Marketing Director Jean Wenzel at 414.226.0362 or jwenzel@scdm.org to reserve your space today.
We look forward to seeing you in Seattle!
Board of Trustee Nomination Period Closes July 20
Impact the future of SCDM and the industry. Submit your nominations today.
The success of SCDM depends on leaders who are committed to improving the organization and the industry.
SCDM is currently seeking nominations for election to the Board of Trustees. There are three openings for terms running from 2010-2012.
If you are interested in serving on the Board of Trustees or would like to recommend a colleague, please complete a brief application and submit it to Executive Director Eloiza Altoro-Acevedo at ealtoro@scdm.org no later than Monday, July 20. You can also apply through the Members Only section of the SCDM Website.
Here are some questions to consider during this nomination period:
- Do you want to share and discuss ideas for improving the discipline of clinical data management?
- Do you want to influence the strategic direction of SCDM?
- Do you enjoy serving in leadership roles?
- Do you know someone who would be a great candidate for SCDM's Board of Trustees?
If the answer to any of these questions is "yes," please submit your nomination.
Eligibility and Process
All SCDM members are eligible to serve on the Board of Trustees. Members may nominate themselves or another SCDM member as candidates. All nominees will be required to complete an application.
Applications will be reviewed and approved by the Nominating Committee prior to announcement of the final slate of candidates Monday, August 3.
Virtual voting will open Monday, August 3, and close Friday, August 21, via the Members Only section of the SCDM Web site.
The new Board of Trustees will be announced during the 2009 Annual Conference Business Meeting, Monday, October 5.
All new Board members are required to attend four face-to-face meetings per year, two of which coincide with SCDM events (Leadership Forum and Annual Conference). They will also be invited to attend a Board orientation and the Board meeting held at the 2009 Annual Conference on Saturday, October 3.
For more detailed information about the SCDM Board and Trustee responsibilities, please review the Board of Trustees Fact Sheet and the SCDM strategic goals and priorities.
New Career Center: Don't Let Opportunity Pass You By
The SCDM Career Center provides the tools to make your employment search efficient and effective - whether you're actively seeking a new position or just keeping your options open.
Create an automatic Job Alert to receive e-mail notifications when new jobs are posted. You set the criteria - job title, industry or location.
Sign up today at careers.scdm.org and never miss new job opportunities again!
The Career Center is designed to connect top-notch employees with quality companies. In June, the Career Center averaged more than 150 job views per day. Dozens of job seekers have created accounts and posted their resumes.
SCDM Online Course - Project Management for Clinical Data Managers
September 7 - October 2, 2009
Course Description
The course will deepen your knowledge of project management concepts and tools especially geared to the Clinical Data Manager, and put this knowledge into practice during course exercises based on real-world scenarios. 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 as they relate to clinical data management. The course also includes how to successfully manage projects with remote and virtual teams.
Course Instructor
Josephine Scrofani, CPLP, Vice President of Training, eClinical Solutions, a division of Eliassen Group; co-author and SME for the GCDMP Project Management chapter.
Online courses fill fast. Take advantage of the early registration discount today!
For further information and registration visit: http://portal.scdm.org/?q=node/290
EDC Today and Tomorrow: 3-part Webinar Series
This ever-popular series returns with important updates regarding the eClinical space and EHR.
EDC Today and Tomorrow
July 9, 23 and 30
11 a.m. - 12:30 p.m. CDT
* Please note that there is no webinar on July 16
Whether you're already working EDC studies or preparing to convert, this webinar will arm you with the latest information on successful use of this emerging technology.
Our expert panelists will share best practices to help you learn to successfully start up, maintain and closeout an EDC study. You'll also gain understanding of the trends and future direction of EDC and the eClinical space - with a focus on how standards and complementary data sources, such as electronic health records, will influence the EDC environment.
2009 Webinar Schedule
For more information and registration, please click on the webinar title below.
| Date | Title | Sequence |
| July 9, 23 & 30 | EDC Today and Tomorrow | Certification Sequence |
| August 13 & 20 | Patient Reported Outcomes | Career Development Sequence |
| September 10 & 17 | Database Validation and Surviving an Audit | Certification Sequence |
| November 5, 12 & 19 | Project Management Toolbox | Certification Sequence |
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 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: Data Acquisition, Database Closure, Metrics for Clinical Trials, 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
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.
- Tolerex
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 is finalizing the agenda for our upcoming face-to-face meeting. This will be held in Milwaukee at the EDI offices July 16-17. It's a great opportunity for us to meet all of the SCDM staff prior to the Annual Conference.
One of the primary items of business involves the future leadership of SCDM. The Nominating Committee will share the names of SCDM members who have expressed interest in running for election to the Board. Those of us already serving must decide if we want to be considered for the Executive Committee, which is elected by the Board at the Fall meeting. If you're interested in nominating yourself or a colleague for the Board, please complete an application.
As part of our quarterly meetings, we receive updates from the committees. It has worked well for us to hear from the chairs about their committees' challenges and successes. We are able to ensure that the work done by SCDM and its volunteers is coordinated and not completed in silos in different committees. All our committees are interrelated, with common goals to advance the Society. Updates to the GCDMP need to be consistent with the certification test and the education committee may want to develop an online course or a webinar on the topic.
Our Board members who serve as committee liaisons help to facilitate this process and keep the full Board informed when significant input is required, decisions need to be made or some communication may be important in our future planning.
At each Board meeting, we are looking at our long term strategy and the current state of the industry. We want to anticipate the needs of our membership to continue to provide you with a valuable professional resource.
I hope you have seen the changes to our Web site. It is more interactive and has more of a professional look. In addition, SCDM has established a presence on Facebook, Twitter and LinkedIn. This is all part of staying current and connecting our membership in various ways. I hope you are taking advantage of these opportunities.
We also felt that it was time to enhance our job posting service. If you haven't seen the new Career Center, I encourage you log on to see the changes. It is just another way we are striving to meet your needs.
As always, feel free to contact us with your suggestions and feedback.
Making Waves - Members in the News
Jonathan Andrus, CCDM, SCDM past chair and vice president, data and study operations, for BioClinica, Inc., has been elected as the Drug Information Association's North American Special Interest Area Community eClinical chair. His term began July 1.
Lori Brix, president of Silent Partners, Inc., presented "Open Source - Open Dialog - Open Cooperation: A Chronicle of Collaboration" at the Drug Information Association's Annual Meeting in June. The presentation included examples of successful collaborations including SCDM's Good Clinical Data Management Practices. Lori identified five keys to success, including broad recruiting for subject matter experts, frequent status reports to Society leaders, and development of a formal project plan.
Nimita Limaye, CCDM, SCDM board member and vice president, clinical data management and medical writing, SIRO Clinpharm, was interviewed on the international growth of CDM in a recent issue of Express Pharma. Read the interview at http://www.expresspharmaonline.com/20090531/pharmalife02.shtml
Linda Talley, global manager-biopharmaceutics, Eli Lilly and Company, will be presenting "Certification for Data Managers - How High is the Bar?" at the 3rd Annual Clinical Forum in Nice, France, October 19-21 at the Nice Acropolis Congress Centre. Linda will also be participating as panelist for the CDM Focus on the Future session at this meeting.
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 Samson O. Adesola, CCDM, as a recent recipient of the Certified Clinical Data Manager designation. Samson is a clinical data specialist with BLCPro LLC in New London, CT.
| Q: | Why did you become certified? |
| A: | To demonstrate my level of proficiency and commitment to the clinical data management profession.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | Finding time to study was a big challenge. |
| Q: | How has being certified benefited you? |
| A: | It made me feel good and increased my confidence in my day-to-day job functions. I strongly believe the long-term dividend will include promotion with good incentives. |
| Q: | What materials did you use to study for the exam? |
| A: |
GCDMP and ICH Guidelines formed the basis; Practical Guide to Clinical Data Management by Susanne Prokscha was also good reading text. However, experience serves as the best teacher. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Study focus group are a good idea to get you familiarized with all competency areas listed for the exam. Also doing extra research studies in those areas that 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: |
I believe having CCDM after your name adds more value to your experience in the profession. It also shows the global world your level of competency and ability to perform a good job in the field of CDM. Therefore, go for CCDM! |
SCDM welcomed these NEW members in May 2009!
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Elly Atuhumuza, BSC Kirti Agrawal, BS Ekaette Akpan Cindy Arlaud, PhD Mary Bancroft Smita Bijoor Sherri Bloomer, MS Christina Bordick Shandra R. Bryant, BS Nicole Burchardi, PhD Laura Burden Karyn Cassello Syam Prasad Chandrala, MS Chris Corral Kymme J. Courtney-Vega, MS Sudhamsh Dandamraj Gale DeHaven, MA Maria Elena Delgado Herrero, BS Scott DeMell Philippe Deram, MD David C. Evans, MA Meredith Fantasia Julie Gatti Eunice Gunneson, PA-C, MBA Beth Hasenauer, RN, MS, CPON |
Andrea Hochheiser Lisa Gail Hogg, BS Marin Hsuan, BS Malin Jakobsson, MSc Pharm Steven Jong Abhishek V. Kadam, BHMS Robin Kearns Fred Kerr Ekaterina Kholodkova, MS Ji-Hyun Kim, PhD M. Susan Korah Sanjay Singh Kushwaha, BPharm Betsy Leung Frank Leus Steve Littlefield, BSEE Lori Littleford Kristina Liu, PhD Thomas Malone Melissa Mau, BS, MS, CCRA Jeff Mexicotte Vanchi Nathan Mike Olds, MA Mary R. Opel Sandra Oyola, MT |
Disia Page Sheryl Pause, BS Antoine Perier Kim Pusey James A. Robinsin Ary Sarkar, MBA Maria Schroeder, MPH Ingrid Shieh, MS Sridevi M. Sridhar Smita Subramanian, MS Mary Szakacs, BS Reiko Takada David Tappe, MS Ellen Tsan, MPH Lynn Vandertie, BSN, MS Mike Vigil Karen Walton-Bowen, MSc, CStat Darlene Watson Nancy K. West, BSN, RN, CCRP Dina Willis Charlotte Wood Shuling Wu, MS Masahiro Yamashita, MS Kyvanc Yuksel, MS |
SCDM congratulates the following members for entering
their 5th year of membership in May 2009!
Robert Bergann
Lutz Hoffmann
Jack Salvo
SCDM congratulates the following member for entering
her 10th year of membership in May 2009!
Barbara Westerfield
