Query Processing & Tracking and Database Updates Online Course
May 9 - May 29
The vast majority of the clinical data manager's time is spent in data clarification, verification and validation. This foundational course will focus on these processes, and contribute to the data manager's ability to identify discrepant data and effectively address data clarification needs. Knowledge from this course can be applied to EDC or paper processes.
Click here for additional information and to register .
SCDM 2010 Annual Conference
Is Your Company Looking for Ways to Gain Exposure?
Become a 2010 Annual Conference exhibitor or sponsor. Packages available to fit all marketing budgets and guaranteed to increase your potential client base. Exhibit booths at the conference begin at $2,800. For even more exposure, SCDM has sponsorship packages available beginning as low as $2,000.
The exhibit hall is open for three days - Sunday, Monday and Tuesday. All meal functions during hall hours are held within the hall, including Sunday night's networking reception.
Increase your company's exposure by submitting an entry for the 2010 Data Driven Innovation Award. All exhibiting or sponsoring companies are invited to submit a product or service developed to benefit the discipline of CDM. For more information, guidelines and an application, click here.
Click here for applications and further information on the 2010 Annual Conference exhibiting and sponsoring opportunities.
Questions? Contact Jean Wenzel at 414.226.0362 or jwenzel@scdm.org.
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.
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| 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 | |
| Data Management Plans | May 20 |
| Overall Clinical Trials Process, Roles and Responsibilities | June 17 & 24 |
| Vendor Management | July 15 |
| Protocol Review | August 12 & 19 |
| Touch Point/Hand Offs (with SAE Reconciliation) | September 16 & 23 |
| CDISC | November 11 & 18 |
Certification Taskforce Volunteers Needed
SCDM is in need of a few dedicated CCDM members to serve on its Certification Taskforce.
Responsibilities
Volunteers are encouraged to participate in a monthly conference call scheduled for the second Monday of each month at 10:30 am CDT / 11:30 am ET and some individual/small group work.
Purpose of the Taskforce
- To ensure that standard criteria and requirements for professional CDM certification reflect industry needs
- To guard against obsolescence in knowledge of clinical data management skills and competencies
- To educate membership and their customers on the value of certification and engage their support
Benefits
Professional Development SCDM taskforces are a great opportunity to gain leadership experience and build your resume.
Networking Work alongside CDM professionals with shared interests. Make new professional connections and lifelong friends.
Make an Impact Taskforces work on focused, short-term projects. Your input and ideas shape the programs we offer.
If you are a CCDM and are interested in volunteering or would like more information, please contact Sue Abrahms, education coordinator, at sabrahms@scdm.org or 414.226.0362.
Please remember, these volunteer opportunities are open to members only. Not a member? It's easy to join.
Calling All CCDMs!
Join the next group of Item Writers for the CCDM exam
CCDMs are needed to write questions for the CCDM exam and other projects like the self-assessment exam and the practice exam. Work will commence with a mid-May virtual orientation presented by a representative of Prometric Testing Service. This will be followed by small groups collaborating to write domain-specific items. The duration of the project will be approximately six weeks including the orientation.
If you wish to join this exciting effort, please send your request no later than May 7 to Sharon Kayne Chaplock at schaplock@scdm.org and include the following: your CV, domain area(s) of interest, and a short paragraph detailing why you are interested and your relevant experience.
Call for Online Course Content Developers
Do you love to teach? Have you been told you're a natural born educator? Is training part of your job? Do you have areas of CDM expertise? Would you like to give back to the CDM profession?
If you answered "yes" to any of these questions, we invite you to join the following Content Development Teams for new SCDM online courses. Active development time when most meetings will occur is included beside each course.
| SAE Reconciliation Safety Review & Coding | April 12 - June 14 |
| Managing Lab Data | July 7 - August 30 |
| Database Lock & Randomization | August 30 - October 1 |
Work includes drafting a course outline, identifying content resources, creating slide decks, drafting discussion questions, and creating assessment items. You will be guided by an experienced instructional designer. As an added benefit, you will learn about the process of creating online courses and be rewarded with participation credits that count toward renewal of your CCDM.
To apply, please send the following to schaplock@scdm.org:
- short paragraph outlining why you want to join the team
- your qualifications
- the course you'd like to work on
- a copy of your resume or CV.
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.
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.
SMEs are eligible to receive participation credits, which can be used toward certification renewal.
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®
I am pleased to tell you that our committees and taskforces continue to make excellent progress towards their goals for 2010. Here's a look at the accomplishments of these volunteers:
Education
SCDM has hosted four webinars so far this year. They are categorized as either Career Development or Certification in order to meet the specific educational needs of attendees. We have also completed two online courses, with a third beginning this month.
Please take a look at the website for further details on the offerings for 2010.
Membership/Certification
As of April 2, there were 1,775 SCDM members, 373 of which were new. This is the start of our new membership year and these figures will continue to grow as we receive renewals and new applications every day. In addition, there are currently 531 CCDMs, with another 43 people who have applied to take the exam.
Marketing & Communications
SCDM has 1,435 followers on LinkedIn, 405 Facebook fans, and 126 Tweeters so far. If you have not connected with one of these social media, I suggest you look in to it. Again this year, there will be live Tweets from the Annual Conference.
Annual Conference
The Annual Conference Taskforce is very busy with the plans for this year's event. The Marketing team is securing sponsors. The Data Driven Innovation Awards reception is being planned. October seems like a long way off, but I know for the Annual Conference Taskforce it does not. I think we all are waiting to see what presentations we will see at the 2010 Conference.
GCDMP
The GCDMP Taskforce continues to be busy rewriting chapters and developing new chapters. Watch for new chapters such as Systems Validation and Project Management for Data Managers. Chapter rewrites include Assuring Data Quality, Vendor Selection & Management as well as Metrics in CDM.
If you are not yet actively involved in SCDM, consider joining a committee or taskforce. I can guarantee that you will learn new skills, gain new information and build your resume. It is a great way to develop yourself outside of your organization. Visit http://www.scdm.org/volunteer for information on the variety of volunteer opportunities available.
Susan K. Howard
Secretary
SCDM Board of Trustees
Get to Know the CCDM®
SCDM is proud to introduce Janine Del Vecchio, CCDM, as a recipient of the Certified Clinical Data Manager designation. Janine is an Associate Director, Clinical Data, with i3 Statprobe in Basking Ridge, NJ.
| Q: | Why did you become certified? |
| A: | I have come to recognize the value of the CCDM designation throughout our industry. It is an undisputed proficiency that can be offered to our clients. It was a logical goal for me to pursue this due to my many years of experience in the field. It was also a goal I established for myself in my personal development objectives.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | I was concerned about the proper way to prepare for the exam, as well as the time commitment for studying for the exam. |
| Q: | How has being certified benefited you? |
| A: | I join many others within my organization who are certified. The certification is an acknowledged strong point for us as leaders and experts within the field. The distinction is highly regarded within my organization. I can pass along this benefit to my clients.
|
| Q: | What materials did you use to study for the exam? |
| A: |
We implemented study groups within our department to review and present the various chapters within the GCDMP. I also had familiarity with the GCDMP as a chapter reviewer, and finally, my extensive career experience. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
The exam spans all aspects within the scope of data management so be sure your knowledge or review covers this. From my perspective, significant experience is a real plus. While sitting for the exam, approach the questions with a clear head, and do pay attention to the wording of both the questions and available responses to make the appropriate selection.
|
| Q: | Any additional comments you would like to provide? |
| A: |
I am pleased to join the great number of people already certified.
|
Looking for a step up in your career?
Why not become a Certified Clinical Data Manager?
For more information visit www.scdm.org/certification
At the recently held Association for Clinical Data Management annual conference, Sagar Kalantre, CCDM, won the JC Amos award for CDM innovation. To compete he had to submit a poster on the conference theme of "Driving Success". Kalantre's poster was titled "Driving Success: A Clinical Data Managers view".
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 March 2010!
|
Constantin F. Aliferis, MD, PhD Jennifer N. Andringa Nancy Bates Roman Berndt Hari Prasad Bharla, PgD Ping Chen Courtney N. Cole Scott Cooley Françoise Couturier Briana K. Davis Grace E. De La Rosa, R.Ph Brice Dubois, MS Karin Duerrstein Sylvester E. N. Ebaye, MB, BS Shirley M. Ellis Denise R. Esposito Pushkala Ganesh Deborah J. Gundberg Lidong S. Huang, MS Maryann Q. Huffert Roberta A. Iskra Carey Jackson Rani Johnson Lucie Jouie, BS Corey C. Keehn Masato Kobayashi, MS Camelia Kouki Robert Lavin Gill Lawrence Jing Li Yanhong Liu Jason Lones Mark G. Mazzie Rachel McGratty Audrey N. Miller |
Sibbie Montgomery, BS Juan Morgan Xicao Niu Lisa B. Olayon Brent Phillippi Carolyn Powers Laszlo Rak Sasivimol Rattanasiri, PhD Lisa Riesselmann, MS Elizabeth Rouse, CCDM Nicholas J. Sardine Teri Schmidt Caola Schonberg, BS Charles B. Servis Andrea N. Seyberth Anna Shaffer Jinato Shi Serena M. Smith, MS, CCDM Michelle B. Starkey Elisabeth A. Steiger Ola Strandberg Weixing Tao Visanu Thamlikitkul, MD Danny Thomas, CDBM Ashley W. Tuck Manoj Kumar V Yanhua Wang Yi Wang June Wheeler Cheryl Whyte Li You Jill Zacios Hui Zhang Janice Zwolshen, BS |
SCDM congratulates the following members for entering
their 5th year of membership in March 2010!
|
Johanna Bronner Catherine Covert Jayne I. Gerega Mary A. Hiller Monte Jarvis Linda King Lyne Lavoie |
Erika T. Miller, CCDM, BA Kirti Pandit Adela Pau Thomas C. Ruflin Sandy Spiro Nicole Wallin Veronique Wilson |
SCDM congratulates the following members for entering
their 10th year of membership in March 2010!
Lee Ann Collins
Kathy Haag, CCDM
Clinical Data Management 2010
June 23-24
Hotel Maritim Berlin
The evidence of the results of research on the efficacy and safety of medicines and medical devices and the acceptance of these findings by regulatory agencies are critically dependent on the quality and validity of the data. In this situation, it is essential for manufacturers to obtain the highest quality, working cost and time efficiently along the entire information chain.
This two-day conference offers the opportunity for top-class professionals of pharmaceutical and medical industries, science and administration to critically deliberate about the presence of clinical data management and to discuss its future. The topics reflect the critical framework in the field of clinical data management and related areas within clinical trials.
5th Trial Design Innovation
July 13, 2010 - July 14, 2010
Sheraton National Hotel, Arlington, VA
ExL's 2006 Trial Design Innovation Conference was the first conference facilitating discussion on the benefits of deviating from standard drug development and outlining strategies for integrating adaptive designs into your current projects to decrease risk and increase the probability of success. Even though multiple events have since emerged on this topic, ExL continues to distinguish itself as the leader by consistently delivering relevant research-driven topics and the highest caliber of speakers.
The trend continues in 2010 with ExL's 5th Trial Design Innovation Conference. This year the conference aims to discuss strategies for innovative new approaches to adaptive trial design incorporating new technology to best utilize resources while weighing the impact of recent FDA Draft Guidance in the field.
2nd Effective Business Development for Clinical Trial Service Providers
July 13, 2010 - July 14, 2010
Sheraton National Hotel, Arlington, VA
Attend this premier conference to
- Understand your clients' needs and provide novel solutions that meet or exceed expectations
- Provide or supplement industry-specific business development training
- Access pharma/biotech decision makers who provide honest insights into how to best serve them
- Promote proactive and prevent "reactive" business development planning in a challenging market
- Get BD strategies whether proposing a fee-for-service, preferred provider, FSP or strategic relationship
Exploit a unique opportunity for internal team building in an intimate, non-tradeshow environment
mHealth Conference
September 14-15
Dubai, UAE
If you want to meet over 200 mHealth project leaders at an event explicitly designed to help them select technology partners, then you need to join us at the inaugural Global mHealth Conference & Expo September 14-15 in Dubai, in The Mövenpick Hotel Jumeirah Beach.
Join hundreds of others to take advantage of this unique event
- First ever truly global mHealth conference with presentations and attendees spanning from Japan to Peru
- Ecosystem: Meet all of the key stakeholders in mHealth: mobile operators, systems integrators, devise manufactures, healthcare professionals, governments, NGOs, application and software developers
- Dynamic: less formal presentations with more interactive panel discussions, Q&A sessions, and a live application shoot-out
- Independent: Your hosts, Clarion Conferences don't represent mobile network operators, hospitals, software or any other stakeholder. We have no software of consultancy services to sell
With over 200 attendees, global case studies, key decision makers, innovative formats and built-in networking time, this is a conference that you cannot afford to miss!
