2010 SCDM Leadership Forum
Industry Forecasting and Leadership Strategies for Tomorrow
March 14-16
San Antonio
Register online
This executive-level forum brings clinical data management leaders together for dynamic discussion on industry trends.
A special keynote session will look outside clinical research to explore how other industries have addressed the challenges of data privacy, security and regulation. Guest speakers from the financial industry will share lessons learned and strategies that can be applied to CDM.
Other discussion topics include managing risk, the impact of globalization and integrating new technology. Participants will provide input on a future whitepaper outlining the future direction of SCDM.
Attendance at this event is limited. Past years have sold out. Register early to guarantee your space.
Interested in becoming a sponsor? Visit http://www.scdm.org/sponsorship/leadership.asp or contact Marketing Director Jean Wenzel at jwenzel@scdm.org.
Preliminary Program:
Keynote
Hot Topics from an Outside Perspective
Data Privacy, Security and Regulation: Lessons Learned from the Financial Industry
Discussion Sessions
Is risk really such a bad thing?
- When to take a chance and when to play it safe
- How to protect yourself and your company from the potential fallout
Does globalization challenge the synergy of CDM?
- Preserving data quality in a fragmented environment
- Developing future leaders when entry-level work is outsourced
Does technology drive the industry or vice versa?
- Identifying which technologies are worth the investment
- Adapting breakthrough technology to influence its future
Call for Abstracts
Interested in sharing your expertise, best practices and insights on clinical data management? We encourage you to submit an abstract for consideration for the 2010 SCDM Annual Conference.
Watch your e-mail or check our website on January 25 for the Call for Abstracts information - including session topics and submission guidelines.
Abstracts must be received by March 29. Speaker candidates and abstracts will be evaluated and selected by the Annual Conference Taskforce. Accepted speakers will be notified by May 10.
The Annual conference is scheduled for October 17-20 in Minneapolis.
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| Data Management Plans | January 31 |
| CRF Design | March 28 |
| Query Processing and Tracking/Database Updates | May 9 |
| Metrics and Identifying Data Trends | June 13 |
| SAE Reconciliation, Safety Review and Coding | July 25 |
| Managing Lab Data | September 5 |
| Database Lock and Randomization | October 10 |
| Project Management for the Clinical Data Manager | November 7 |
| 2010 Webinar Schedule | |
| Database Updates Webinar | January 28 |
| Lab Data Webinar | February 25 |
| Coding | March 18 |
| Data Management Plans Webinar | April 22 |
| Managing Virtual Teams Webinar | May 20 |
| Overall Clinical Trials Process, Roles and Responsibilities Webinar | June 17 & 24 |
| Protocol Review Webinar | August 12 & 19 |
| Touch Point/Hand offs (with SAE Reconciliation) Webinar | September 16 |
| CDISC Webinar | November 11 & 18 |
On Demand Webinars
SCDM On Demand Webinars offer the convenience of viewing and listening to recordings of live events on your schedule. Click here for the most recent webinar recordings available.
Enjoy Reading Data Basics?
Now is Your Chance to Contribute to the Next Issue!
| Themes | Submission Deadline |
| Reaching Across the Organizational Divide | 2/2/2010 |
| Virtual Teams/Project Management | 5/4/2010 |
| Data Quality | 8/3/2010 |
| Pharmacogenics and Metibomics | 11/2/2010 |
This is your opportunity to earn SCDM participation credits toward certification renewal.
Please contact Sue Abrahms at sabrahms@scdm.org for submission requirements.
Resolve to Get Involved
2010 Call for Volunteers
We know you're busy. Still, we encourage you to get the most of your SCDM membership by participating in one of our many volunteer opportunities.
The success of SCDM relies on the input and expertise of members like you.
Volunteering on an SCDM taskforce is a valuable, rewarding experience. Build your resume and professional network - and leave a legacy. Your volunteer participation influences the future of SCDM and the industry.
Please note that these volunteer opportunities are available only to SCDM members.
Featured Opportunity
Marketing Taskforce Leader
SCDM is seeking the expertise of a leader to offer creative solutions and help guide implementation of the organization's marketing plan. Qualified candidates will have knowledge of marketing strategies and trends and ability to complete projects on deadline. Marketing or sales background helpful but not required.
Candidates will be evaluated and selected by the SCDM Marketing & Communications Committee.
If you are interested in applying for this position or would like to recommend a colleague, please e-mail volunteers@scdm.org.
Other Openings
Certification Taskforce
Analyze certification trends to suggest improvements and promotion opportunities of the CCDM program.
Publications Taskforce
Select issue themes, brainstorm article topics and edit content for accuracy. Writing and editing skills a plus!
Webinars Taskforce
Identify subjects, speakers and audiences for SCDM educational webinars. Monitor industry education trends and suggest improvements for SCDM offerings.
Online Course Taskforce
Identify subjects, instructors and audiences for SCDM online courses. Monitor industry education trends and suggest improvements for SCDM offerings.
Marketing Taskforce
Shape strategies and provide feedback on SCDM marketing initiatives, including membership communications, meeting/program promotion and partnership opportunities.
If you're interested in any of these exciting opportunities, please contact SCDM at volunteers@scdm.org. For more information, you can also visit our volunteer page online. We look forward to hearing from you!
Item / Question Writers Wanted
WANTED! - SCDM Item Writers, Volunteers to Contribute to the Future of the CCDM Certification
SCDM is looking for 20 Subject Matter Experts (SME's) to write questions for the next version of the Certified Clinical Data Manager exam, and to support ongoing educational opportunities by writing questions for practice exams and online courses hosted by SCDM.
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 guidances
- Must have the available time needed to serve in the capacity of SME, estimated to be approximately 40 hours over the course of the assignment
- A collaborative attitude and a commitment to contribute to the development of the CDM profession
Work on the next version of the certification exam will begin in the first quarter of 2010 and continue until the test is ready for rollout in 2011. Item writing for online courses will be an ongoing activity. Appropriate training and access to reference materials will be provided.
If you are interested in becoming an Item Writer for any one of these activities, please prepare a half-page statement of interest in which you describe the GCDMP chapter(s) or topics for which you are qualified, and your experience that qualifies you as a Subject Matter Expert. Send your statement of interest and your CV to Sharon Kayne Chaplock at schaplock@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: Protocol Review, Safety Data Management and Reporting, Data Integration, Preparing For and Surviving an Audit, Data Storage and Detecting Fraud.
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 Amanda Knack at aknack@scdm.org.
BoT Update
Looking Back with Pride, Looking Forward with Anticipation
As I write this, 2009 is coming to a close. SCDM had a very productive year, despite the financial challenges faced by our industry, our companies and each of us as individuals. Here's a quick recap of some highlights:
- Annual Conference attendance, sponsorship and revenue surpassed all of our expectations.
- The Leadership Forum in March was also a success; a distinguished group of CDM leaders participated in discussions on emerging trends, risk management, and strategic leadership.
- The GCDMP committee revised several current chapters and developed five entirely new ones - Data Entry Processes, Data Management Standards in Clinical Research, Edit Check Design Principles, Laboratory Data Handling and Patient-Reported Outcomes. The resource is also being translated into Japanese, an effort that furthers our international reach.
- The number of people earning the Certified Clinical Data Manager designation continued to rise and we saw an uptick in the number of exam-takers from outside of the United States.
- We expanded our webinar offerings and launched a series of online learning programs. This will continue in 2010; the schedules are posted and our first participants have already signed up.
The Board of Trustees is currently preparing for our first board meeting of 2010, in mid-January. At this meeting, we will discuss trends we see from our individual perspectives and trends we pick up from the news or from others in the industry. We will approve the new year's budget, trying to ensure we meet the needs of our members, expand our services and maintain financial security. We will also review our current partnerships with related organizations and explore what partnerships may be appropriate in the future. We will discuss membership trends, our marketing plans and publication strategies. The end result is what we call our "strategic directions" - goals that we present to our committee chairs, via teleconference, at the end of the Board meeting. These serve as guidance for the projects the committees and taskforces will undertake in the coming year.
The individuals serving on our committees and taskforces are leaders in our Society. Throughout the year, our Nominating Committee will be on the lookout for members to recommend for enhanced roles in our organization. Please feel free to contact any of us for more information about becoming actively involved in your Society. It is a unique opportunity to develop your skills across the industry, rather than just in your own company, and to make the most of your membership in SCDM.
Susan K. Howard, Trustee SCDM
Therapeutic Program Manager
Oncology Data Management
GlaxoSmithKline
Get to Know the CCDM®
SCDM is proud to introduce Sagar Kalantre, CCDM, as a recipient of the Certified Clinical Data Manager designation. Sagar is a Clinical Data Associate with Kendle International in Ahmedabad, Gujrat, India.
| Q: | Why did you become certified? |
| A: | This industry-wide certification helped me attest my CDM knowledge base.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | The biggest challenge was to go through all the materials gathered from various sources. The second challenge was to get myself acquainted with areas to which I had not been exposed earlier.
|
| Q: | How has being certified benefited you? |
| A: | The process of getting certified was very valuable. I can see a significant increase in my CDM knowledge base. As for the certification, I have already received accolades from even the senior management at my company. It is too early to assess other benefits.
|
| Q: | What materials did you use to study for the exam? |
| A: |
Lots. Apart from the sources listed on the SCDM Web site, material gathered from a few other Web sites served as good sources of information. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Plan early and go through all the resources you can. CCDM® will just be a side effect…
|
| Q: | Any additional comments you would like to provide? |
| A: |
a. Get trained in or read about as many cross-functional areas as possible. b. They say GCDMP is The Bible. Definitely use the GCDMP as a guideline but make sure you read other material as well. To all those who are taking the exam: All the Best !! |
Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to Sue Abrahms at sabrahms@scdm.org.
SCDM welcomed these NEW members in November 2009!
|
Laura Adamson, BSN, OCN, CCRC Marjorie Andrada, BS Pamela Andreyko Tania Araujo, MPH April Balousek, BSN. OCN, CCRP Erin Beaman, RHIA Nancy Bithell Kelly Boelter, BS Linda Boudreau, ABS Bhupinder S. Brar, BAMS Rachel Chae, PharmD Douglas Christian, BA Shawna Cote, BS Tammy Davis, BS Qian Ding, PhD Irenee Domkam Kammogne, MS Kathryn Donald, CCRP Joan Dupont, PhD Peter Durrer, PhD Deborah Dusi, RN John W. Dyba, BS Stephanie Finn, MS, MBA Jenny Fung Jalina George Diane M. Gosik, RN, BS Jitendra Gowda Narasimham Gubbala Kendra Harris Amanda Hickman, BS Lucinda Hopewell, BS Gail L. Hoshiko-Reed, BS Joe K. Hulsmann, MA Jacqueline Hummel Amanda Idan, Bsc Katharina Jakaitis, BS Wendy Kramer Holley Kvetko, BSN Judy LaJoie, BSN, RN Christopher Lamplugh, MBA Lori Leung Tiffany Lewis, BS |
Lynda Luttrell, BS, BA Bindu Malkan, BSc, DMLT, PGDCDM Tracie Maurice Pierre Mayeur, MS Alejandra Miranda Gene Moldavchuk, MS Marcus Moore III, BS Cecilia Moresino, MS Mary Morris, BSN, MS Mildred Mortillo, BS Soumya Nandy, MBA Rachel Neff, BS, MPH Ngan Nguyen, BA Erin O'Connor, BS Nearl Phillips, PhD Lauren Queler, BS Amy Suzanne Ricker Cynthia Rosewicz, MS Shuvodev Roy, MS Pooja Sadarangani, BS Satender Sajwan, MPhil (CS) Nagarajan Sangeetha, MCA Vindu Seal, MA Adnan Shawkat, BS Socorro R. Sisneros Kelli A. Skovira, BSN, OCN Michelle Smerek, BS Stephanie Sproule, BSc, MMath Melanie A. Stein, BBA Marni Tierno, PhD, RN Vicki Tipton, BS Padma Tirumalai, PhD Penelope Valentik, MEd, CHES, RRT Caroline Wagle Marion Wagner Ashley R. Waldrep, BS Narinder Walia, BS James Welcher, MA, RAC Lynne M. Weston, BS Anne Wilks, MS Jennifer Zimmerer, MS, RD, CCRP |
SCDM congratulates the following members for entering
their 5th year of membership in November 2009!
|
Miya Beeler-Garaway Andrea Black, CCDM Carrie Loebertmann Francis McDonald Hanzal Muhusin |
Andrea Priewe Herminio Sinoy Diane Stasser, CCDM Jennie Tedrow Ha Tran, CCDM |
SCDM congratulates the following member for entering
her 10th year of membership in November 2009!
Mary-Lou Keating
SCDM and IIR Offer Registration Savings to Central Labs West
Through a partnership with the Institute for International Research, SCDM members receive 25% off the cost of registration to the Central Labs West conference, February 3-5 at the Grand Hyatt in San Francisco.
Register online and enter code XPSCDM to receive the discounted registration rate. Only SCDM members qualify for this special rate.
About Central Labs West
This event brings together the world's premier pharmaceutical and biotech clinical research, data management and outsourcing executives to share best practices, establish standards and leverage novel scientific laboratory techniques to improve the efficiency and quality of global clinical trials. With an outstanding speaking faculty and access to leading central labs, ECG core labs, imaging core labs, specialty labs and couriers and other small, medium and large pharmaceutical sponsors, this event will add critical business value now. Prepare your company for more streamlined and compliant drug development with solutions to handle day-to-day outsourcing, procurement, operations and data management. Visit www.centrallabswest.com for more information, or read the IIR blog or follow IIR on Twitter.
SCDM Members Receive Discount on ExL Pharma's Site Selection, Activation and Communication Conference
SCDM members qualify for 15% off the cost of registration to ExL Pharma's Site Selection, Activation and Communication conference, February 1-2 in Washington, DC.
When registering, enter code SCDM to receive this special rate.
About Site Selection, Activation and Communication
The selection and evaluation of clinical sites and investigators is critical for the successful completion of clinical trials within budget and timelines. The site selection process and the sponsor-site-investigator relationship are key areas of opportunity in accelerating the drug development process while generating high quality data.
While most conferences remain focused on only one or two aspects of sponsor and site relationships, this conference takes an in-depth look at specific steps and a critical analysis of existing practices, challenges and opportunity to formulate a more solid partnership between sponsors, sites and investigators.
For more information or to register, please visit www.exlpharma.com/siteselection.
