- 8+ years of experience in Clinical Data Management with handling paper studies and EDC studies
- Additional responsibility as Training Coordinator for the team.
- Overall knowledge of Clinical Research, Good Clinical Practice, ICH and Regulatory activities.
- Overall knowledge of various therapeutic areas.
- Knowledge of drug development process.
- Good Knowledge is discrepancy management of clinical data.
- Hands on Experience in Electronic Data Capture Tools like RAVE & OCRDC.
- Trained as Validation lead with good knowledge in document writing, SOPs, SWIs etc.
- Possesses innovative thinking and Good Communication Skills.
- CDISC & SDTM basic proficiency.
Global Clinical Data Manager for Janssen Pharmaceuticals
Since September 2015
- Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations - Is the liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s) - Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation - Is a member of SMT and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock) - Participates in Kelly OCG continuous improvement initiatives and training/coaching sessions
Clinical Data Lead
November 2012 --- July 2015
Take part in study kick (internal) off meeting along with the DMPM/PL Read, ensure understanding and adhere to the study contract and scope of work for all tasks during set up, maintenance and close out of the study. Support/Lead the development of specifications for the ECRFs or paper CRF. Lead the development of specifications for the edit checks and data review and oversight listings (DVS). Support development of DMP and Study Specific Procedures. Perform User Acceptance Testing of database, procedures and checks. Support Study Lead with metrics and status reporting on the study. Lead development of specifications for custom reporting on the study. Organize and lead as required regular internal data management team meetings. Attend cross functional study team meeting both internally and with the sponsor. Maintain and track meeting minutes, issues and decision logs, and escalations. Provide regular study status update to the DMPM/Associate DMPM. Support the DMPM/ADMPM in the delivery of study specific training to all team members, ensuring that the training is documented and documentation filed in the DM study files. Assess the training needs of study team members on an on-going basis. Provide refresher training to team members as required. Provide feedback to the DMPM/ADMPM on issues with study team member performance.
September 2011 --- November 2012
• Worked as a Team Lead and handling a team of 8 members • Taking care of Due Diligence and Transition of Projects • Data validation • Mentoring the team whenever necessary. • Preparing metrics and reports required to analyze the team performance.
January 2008 --- September 2011
•Review and action queries on an ongoing basis and update database based on the query resolutions. •Develop eCRF Review Manual and eCRF Instructions (for EDC studies). •Develop CRF Review Manual and Instructions for the Investigator (for paper studies). •Review EDC-Core Configuration against study requirements and assess need for any amendments. •Create and maintain study CRF data standard document. •Perform UAT according to Validation Plan of all applicable Data Management systems. •Maintain Data Management related operational data flows. •Review reports and take actions as defined in the DMP or eCRF review manual. •Provide listings for review to study team (i.e. Client) as per the timelines defined in the Data Management Plan (DMP) and process discrepancies found from reviews. •Perform ongoing and final consistency checks, review protocol deviation handling document and data listings to ensure that all data have been handled appropriately according to the DMP and eCRF Review Manual. •Perform updates post database lock if any.
AdaptabilityApproachabilityAuthenticityAttention to detailAssertivenessCoordinationDependabilityDiligenceIndependenceInterest in knowledgeKindnessOptimismTrustStriving
Skills and Expertise
Build and manage the Trial Master File (TMF) Control data Design case record forms Guide students Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdministrative supportAdverse event reportingClinical data collectionCoach and provide guidance to clinical staff.CoordinationCreate clinical documentsDesign study documentsDesign study
M.Sc in Bioinformatics from Stella Maris College in 2007
B.Sc. in Microbiology from MGR Janaki College For Women in 2005