Senior Associate-Clinical Data at Eli Lilly
Indianapolis, Indiana Area
- Current
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- Senior Associate-Clinical Data at Eli Lilly
- Past
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- Trial Data Associate at Eli Lilly
- Data Management Analyst - Study Set Up at Eli Lilly
- Research Associate at IUPUI School of Informatics
- Research Analyst at Indiana University School of Medicine
- Research Assistant at IUPUI School of Informatics
- Intern Scientist-Discovery Research at Dow AgroSciences
- Web Developer at Indiana University
- Software Engineer at CGI (formerly IMR Global)
- Education
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- Indiana University-Purdue University at Indianapolis
- Acharya N.G. Ranga Agricultural University
- C.R.S. Advanced Computer Education
- Connections
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64
connections
- Industry
- Pharmaceuticals
- Websites
SudhaRani Mamidipalli’s Experience
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Senior Associate-Clinical Data
Eli Lilly
(Public Company; LLY; Pharmaceuticals industry)
August 2009 — Present (4 months)
1. Deliverable Ownership and Vendor Management (50%)
- Define Lilly business requirements for the study for vendors to deliver.
- Ensure that data management deliverables are delivered to scope, cost and time objectives.
- Execute project monitoring and quality oversight of sourcing providers from study set up through trial execution through dataset delivery.
- Drives data flow design through consultation, review, and approval of vendor work.
- Approve key deliverables (i.e. Data quality Delivery Plan, Datalock Plan, Project Plan, database, and observed datasets).
- Define and approve data quality and submission deliverables.
2. Phase I/ Biopharm Clinical Trial Leadership (35%)
- Specifies the data collection tools and technology platforms for the trial/program.
- Drive standards decisions, implementation and compliance for the study/program.
- Facilitate/assimilate integration of disparate data sources into datasets for decision making.
- Utilize therapeutic knowledge and apply regulatory knowledge (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy) to data deliverables.
3. Process Improvement (10%)
4. Asset Protection (5%) -
Trial Data Associate
Eli Lilly
(Public Company; LLY; Pharmaceuticals industry)
November 2008 — July 2009 (9 months)
- Owner and Leader for clinical data deliverables at molecule/indication (group of trials) level.
- Create and manage study work orders (budgets and contracts) for US Early Phase Clinical Trials.
- Primary contact for Lilly team and Vendors for data strategy, planning, requirements, deliverables and solutions.
- Responsible for global consistency of medical data – structure, content, meaning, acquisition, storage, retrieval, interchange and representation.
-Execute project monitoring and quality oversight of sourcing providers for clincial data management activities from study set up through database lock.
- Represent Data Sciences processes in cross-functional initiatives.
- Effectively apply knowledge of internal, external and regulatory requirements to data deliverables. -
Data Management Analyst - Study Set Up
Eli Lilly
(Public Company; 10,001 or more employees; LLY; Pharmaceuticals industry)
October 2007 — October 2008 (1 year 1 month)
- Designed, developed, implemented and validated InForm-CIS-Clintrial (ICC) trials (Phase 2,3,4).
- Leveraged relationships and shared key learnings with ESPs (TCS, Phase Forward).
- Actively involved in Six Sigma team projects (Compound specific data collection strategy - Cialis) and Critical Chain project management methodology (GLP).
- Assumed additional responsibility to ensure quality deliverables i.e. Study Build Approvals by Study Build team of 16 members. -
Research Associate
IUPUI School of Informatics
(Educational Institution; 10,001 or more employees; Research industry)
June 2007 — October 2007 (5 months)
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Research Analyst
Indiana University School of Medicine
(Educational Institution; 10,001 or more employees; Research industry)
June 2006 — May 2007 (1 year )
1. Le-Niculescu et al (2008) Identifying Blood Biomarkers for Mood Disorders Using Convergent Functional Genomics. Molecular Psychiatry. Acknowledged for the precise work with database maintenance and data analysis.
2. Le-Niculescu et al (2007) Towards Understanding the Schizophrenia Code: An Expanded Convergent Functional Genomics Approach. Am Journal of Med Genetics Part B (Neuropsychiatric Gen) 9999:1-32. Acknowledged for the excellent help with Bioinformatics.
3. Le-Niculescu H, McFarland MJ, Mamidipalli S et al (2007). Convergent Functional Genomics of bipolar disorder: from animal model pharmacogenomics to human genetics and biomarkers. Neurosci Biobehav Rev;31(6):897-903.
4. M.J.McFarland, H.Le-Niculescu, Y.Balaraman, C.Ogden, J.Tan, S.Patel, M.Rich, S.Mamidipalli et al (2007) Mice Lacking the Circadian Clock Gene DBP: A Stress-Reactive Animal Model for Bipolar (Manic-Depressive) Disorder and Co-Morbid Alcohol Abuse. IPR 50th Anniversary Symposium. -
Research Assistant
IUPUI School of Informatics
(Educational Institution; Higher Education industry)
August 2004 — January 2006 (1 year 6 months)
1. HAPPI: an Online Database of Comprehensive Human Annotated and Predicted Protein Interactions (2009) J. Y. Chen, S. Mamidipalli, T. Huan. BMC Genomics, Vol. 10, Supplement 1, S16
2. Identification of genetic variants in the human indoleamine 2,3-dioxygenase (IDO1) gene, which have altered enzyme activity (2009) M.Arefayene, S.Philips, D.Cao, S.Mamidipalli, Z.Desta, D.A.Flockhart, D.S. Wilkes, T.C.Skaar. Pharmacogenetics and Genomics: June 2009, Vol. 19, Issue 6, pp 464-476
3.Current Topics in Human Genetics: Studies in Complex Diseases (2007) S. Mamidipalli, J.Y.Chen Protein-Protein Interactions: Concepts, Databases, Software tools, and Biomedical Implications 539 (24). ISBN-13: 9789812704726. Publisher: World Scientific Pub Co Inc.
4. OligoMatcher: Analysis and Selection of Specific Oligonucleotide Sequences for Gene Silencing by Antisense or siRNA (2006) S.Mamidipalli, M.Palakal, S.Li Applied Bioinformatics, Volume 5, Number 2, pp. 121-124(4), PMID: 16722778
5. HAPPI: A Bioinformatics Database Platform Enabling Network Biology Studies (2006) S.Mamidipalli IUPUI Digital Archive Informatics Graduate Thesis -
Intern Scientist-Discovery Research
Dow AgroSciences
(Public Company; DOW; Chemicals industry)
May 2005 — August 2005 (4 months)
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Web Developer
Indiana University
(Educational Institution; 10,001 or more employees; Higher Education industry)
May 2004 — August 2004 (4 months)
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Software Engineer
CGI (formerly IMR Global)
(Public Company; GIB; Information Technology and Services industry)
1997 — 2000 (3 years )
SudhaRani Mamidipalli’s Education
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Indiana University-Purdue University at Indianapolis
M.S. , Bioinformatics , 2004 — 2006
Algorithms in Bioinformatics, Informatics Data Management, Introduction to Informatics, Seminar in Bioinformatics, Data Mining, Independent Study, Database Systems
- Activities and Societies:
- • Indiana University-Purdue University Indianapolis Graduate Student Fellowship, 2004 - 2006
• Outstanding Graduate Student Award , IUPUI, 2006.
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Acharya N.G. Ranga Agricultural University
B.S. , Agriculture
Agronomy, Plant Physiology, Genetics and Plant Breeding, Statistics and Mathematics, Agricultural Economics, Entomology, Plant Pathology, Agriculture Extension, Horticulture, Soil Science, BioChemistry
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C.R.S. Advanced Computer Education
PostGraduate Diploma , Computer Applications
Additional Information
SudhaRani Mamidipalli’s Websites:
SudhaRani Mamidipalli’s Groups:
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Indiana University Alumni Network -
India Leadership Network -
Clinical Research Professionals -
Life Science Professionals -
Linking Indiana -
Lilly Employees -
IU Informatics -
Informatics Career Services Office, Indianapolis
SudhaRani Mamidipalli’s Honors:
- Nominated by Dean’s Office in Informatics to be featured as a top graduate from School of Informatics at the IUPUI Commencement ceremony, May 2006.
- Reviewer, Bioinformatics Track. ACM Symposium on Applied Computing (SAC 2006, 2007).
SudhaRani Mamidipalli’s Contact Settings
Interested In:
- career opportunities
- consulting offers
- new ventures
- job inquiries
- expertise requests
- business deals
- reference requests
- getting back in touch
