Resume_11Feb16
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- The document provides a summary of the professional experience of Thanuja T, including over 10 years of experience in clinical data management and project management roles, primarily at Quintiles. Some of the key responsibilities and experiences mentioned include serving as a Data Team Lead for 4 oncology projects at Quintiles, managing a team of 7 members, involvement in clinical data management from study start up to database lock, and experience working with data standards and platforms like INFORM, RAVE, and OC/RDC.
Resume_11Feb16
- 1. THANUJA T AG04, Manar Elegance Apts, Somasundrapalya, HSR Layout Sector 2 BANGALORE- 560102. Email: thanuja2006@gmail.com Ph No:+919886033874 SUMMARY: With 10 years experience in clinical data management I have vast knowledge in clinical research. Currently working as Data Team Lead for 4 Oncology projects. As a DTL I handle the finance of the projects. Analyze the realization of the project monthly basis and work towards getting higher realization. Also do monthly invoice to the client. Preparing project plan and implementing the timelines per the plan. Client negotiations and risk management are my strength as project manager. I am doing a dual role in Quintiles as a DTL for 4 trials and Line manager for 6 people. Hence I take part in compensation, ranking and ratings for my team members. Involved in career growth and motivation of the team members. Team outings and team encouragement are a part of my role. Started career as Research Scientist at Jubilant Biosys Ltd from Aug 2005- Jul 2006 Worked as Certified data validator in Accenture from Jul 2006- Aug 2008 in Neuroscience therapeutic area in Accenture. Currently working in Quintiles as Associate Manager. Have 7.6 years experience in Oncology and 5 years experience in project management. Involved in end to end process in clinical data management. Worked in SDTM standards. People management experience of 2 years and currently handling 7 reports. Playing dual role of project management and people management. Good communications skills, team work and team management. Platforms worked: INFORM, RAVE, OC/RDC 1
- 2. WORK EXPERIENCE: SL.No Company Role Duration 1 Quintiles Pvt Ltd Associate Manager Oct 2015- Till date 2 Quintiles Pvt Ltd Assistant Manager Oct2013- Oct 2015 3 Quintiles Pvt Ltd Sr. Clinical Data Coordinator Oct2010-Oct2013 4 Quintiles Pvt Ltd Clinical Data Coordinator Aug 2008-Oct2010 5 Accenture Pvt Ltd Certified Data Validator Aug 2006- Aug 2008 6 Jubilant Biosys Pvt Ltd Research Scientist July 2005-Aug 2006 Role Wise Experience: 1. Associate Manager /Data Team Lead : working from Oct 15-till date PLACE:QUINTILES Role: Data Team Lead: Provide expert skills as part of a Clinical Data Management team to provide efficient, quality data management products that meet customer needs. Provide leadership to the team in the area of Project Management and viewed as an expert in data management. Will provide leadership to the team as Data Team Lead (DTL) and Subject Matter Expert for DOCs. Serve as Data Team Lead (DTL) on a program of global studies. Provide leadership to DM team. Manage DM customer relationship for DM project team to include leading (with minimal guidance) DM customer negotiations on complex timeline, budgetary and other issues. Provide marketing capabilities presentations and business development presentations. Role: People Management: Manage staff in accordance with organizations policies and applicable regulations. Responsibilities include planning, assigning, and directing work; 2
- 3. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. Current capacity of team members is 7 since I am handling 4 Oncology projects. 2. Associate Data Team Lead/Assistant Clinical Data Manager - from Oct 13-Oct 15 PLACE:QUINTILES Role: Data Team Lead: Serve as primary point of contact for customer on data management deliverables Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources Maintain strong customer relationships Ensure open communications with customer and Quintiles management to manage and meet contractual obligations Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders Support DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables Create and/or review and sign-off on all data management plan (DMP) documents Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW Implement proactive quality management plans across multiple projects/program. Track service performance and provide leadership to identify root causes of issues and implement remedial actions 3
- 4. Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organize and drive change across multiple projects/program (with minimal support) Ensure timely follow-up and resolution of compliance issues Serve as Subject Matter Expert (SME) -Provide leadership and expertise in a specific CDM task or technology Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff Maintain internal tracking databases and systems Financial Management/Business Development Support: Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW) Manage SOW/budget- Review financial reports on a monthly basis and participate in project reviews as requested - Identify out of scope tasks and track change orders to completion Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing Role: People Management: People management for a team consisting 7 members. Guide the every team member of their career goal. Help in individual improvement and expectations depending their role and experience of the team members. Conduct frequent team meetings and team outings. Involved in individual ratings and performance bonus. 3. Senior Clinical Data Coordinator- from Oct10- Oct13 PLACE:QUINTILES Serve as a Data Operations Coordinator (DOC) in leadership role in a specific area of process on Oncology studies. Conduct data review and training process for the team and groomed the team the team Write and resolve data clarifications Lead database audit team Develop and test databases and edit specifications 4
- 5. Understands and comply with core operation procedures and working instructions Perform other duties and directed by the Functional Manager Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team and the clients. Manage delivery of projects through full data management study life-cycle (with minimal guidance). Manage project timelines and quality; determine resource needs; identify out- of scope work. Independently bring project solutions to the CDM team Solve issues through using the global issue escalation/communication plan. Consult with Standards Group for process issues; communicate ideas for process improvement. 4. Clinical Data Coordinator working from Aug 08- Oct10 PLACE:QUINTILES Lead for 2 oncology studies as a Data operations Coordinator. Involved directly with sponsor and other stakeholder to design and coordinate startup, conduct and DB lock activities. Working in the Clinical Research Organization. Exposed to end to end solution for the data management and validation of the studies. Worked in the start up of the study. Validated and worked on the checks and conditions required for the start up of the study. Also, have experience on the conduct phase of the study that requires constant follow up and current on data. Learned the local lab value checks and its relative activities. Worked on back end checks and frontend checks. Worked on INFORM platform and RAVE platform. Some of the tasks I have excelled in: UAT of backend edit checks UAT of frontend data Ecrf frontend validation 5
- 6. Discrepancy review and query management Lab review both local and central labs Handling medical queries Expert in protocol deviations and reporting of deviations Hands on experience on some of the paper based study review. Well-versed with various backend tools Worked on coding queries and sending appropriate feedback. Trained and mentored the new members of the team. I have been the single point of contact for the clients and the team members for various updates in the study. Taken up tasks of team management and work allocation being the SPOC. Maintained a calm and good rapport with all the team mates that helped to face the extreme pressure during database lock. 5. Worked as Certified data validation associate Accenture Pvt Ltd, from Jul 06 to Aug 08 (2 years) PLACE: ACCENTURE PVT LTD Have handled 2 studies on clinical drug test on patients till database lock in therapeutic area neuroscience. Got a clear-cut knowledge of the clinical trials and worked on it. Have good knowledge about lab data and medical terms that are need to be standard for the clinical database. Written guidelines and improvised on data cleaning through various tools like Oracle database and OC. 6. Worked as Research Scientist at Jubilant Biosys Ltd, since August 2005 in PathArt project from Aug 05 to Jul 06(11 months) PLACE : JUBILANT BIOSYS LTD 6
- 7. PROJECT: PathArt PathArt is a comprehensive collection of manually curate data on more than 1000 signaling and metabolic pathways taken from literature as well as public domain databases. I have worked on diseased pathways like Stomach Cancer and physiological pathways like Thrombopoiesis, Myogenesis, Monopoiesis, Neurogenesis, where I was involved in data mining, annotation and curation of the pathways and application of skills in database creation. My expertise lies in identification disease pathways and the critical disease genes, pathway crosstalk, comparison of pathways across physiologies, diseases, and organisms. Education Qualification M.Sc Biochemistry from Bangalore University: 2003-2005 B.Sc Biochemistry, Genetics from Bangalore University: 2000-2003 Seminars and Symposiums: Presented on the following topics: Diabetes Mellitus: an overall summary of biochemical changes in body during Diabetes and brief note on causes, diagnosis, effects and cure to the disease. Amphipathic Peptides and Drug Delivery: a review article on cell penetrating amphipathic peptides having a wide application in gene therapy and drug delivery. This article is based on the principle that hydrophobic and hydrophilic residues of the peptides interact with the plasma membrane facilitating the peptide delivery. Novel Monoclonal Antibodies Demonstrate Biochemical Variation OF Brain Parkin with Age: a research article dealing with the production of antibodies for protein called Parkin which modified in Parkinsons disease. Presented overview and data management review for the study project I worked in Quintiles. Attended: Bioneers a three day symposium conducted by Jain Group Of Institution 7
- 8. Seminar on Auto- antibodies by Dr Srinivas Kaveri, Pasteur Institute. Seminar on polyviral disease by Dr H.S Savitri, Professor of Department of Biochemistry IISC. Project: Undergone training in EROS PHARMA LTD in the areas of Quality Control of Pharmaceuticals with a focus on HPLC methods of analysis for 15 days. This project has given an exposure to handle instruments like FTIR, Polarimeter, K.F titremeter, and spectrophotometer, HPLC. References: Available upon request. 8