Wednesday, December 13, 2017
The webinar will run twice:
7 AM CT / 8 AM EST / 2 PM CET / 6:30 PM IST / 8 PM CST
10 AM CT / 11 AM EST / 5 PM CET / 9:30 PM IST / 11 PM CST
The goal of a data management plan is to consider the many aspects of data management and analysis before the project begins, to ensure that data are well-managed throughout the course of the study, and prepared for preservation in the future. While the style and format of data management plans differs across organizations, this webinar will identify the essential components of a data management plan. The components will be described in detail discussing the elements of each component. The participants in this webinar will be provided with a general template for a data management plan. This webinar will provide the skills and knowledge to create a data management plan to ensure compliance with good clinical data management practices.
• Discuss and define the essential components of a data management plan.
• Define the elements for each component.
• Discuss on the difference of style and format across organizations.
• Provide the skills and knowledge to create a data management plan to ensure compliance with good clinical data management practices.
Poulamee is a Biotechnologist with more than 10 years of experience in Healthcare/Pharmaceutical Industry with considerable experience in managing studies as a Lead data manager and handling line management activities as an Associate manager with 23 people reporting to her including study leads. She has been a part of starting up and ramping a Full Service Project as a manager. As a Study Matter Expert and trainer for CDM processes, Poulamee has trained Sites/CRAs on eDC systems at Investigator meetings. She carries a good knowledge on GCP, ICH and other regulatory guidelines and has been handling study budgets and resource management as a lead. She is currently working as an Associate Manager at Clintec International, and volunteer in the effort to update the GCDMP standards chapter as an author and SME for SCDM.
Poulamee's experience spans across all phases of data management life cycle from Database build to Database lock to budget and resource management, till final documents submission. With hands on experience in drafting KPIs, RFPs; preparing Proposals, participating in Bid Defense, Client management, SLAs, Appraisal Management, Gap analysis, operational excellence etc, she has participated in cross functional/Client meetings for project planning, kick off and close out. She has also been driving the studies (including submission studies) as Lead and have locked them successfully.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
*Please note that a group should be constituted of max. 10 people who will be allowed to take the assessment questions after the webinar. Different members of one group will be able to log in from different regions of the world.