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 has locked them successfully.