Summary
Overview
Work History
Education
Skills
Accomplishments
Key technical skills
Timeline
Generic

Swathi Enugala

Hyderabad

Summary

  • End to end operational excellence specialist with over 10 years of expertise in stakeholder management and project management, create a high performing team data driven insights. My work was acknowledged with multiple awards during my One decade of professional journey
  • Handled 8 Phase II/III clinical trails (11000 patients) in different therapeutic areas along with regulatory documents like IB, PSUR, DSUR. As a lead CSE, enabled new ways of working, increased efficiency in the team through reports automation and new data visualization apps which improved data quality and more productivity in the team, ultimately resulted in achieving the timelines early. Worked as Coach for new associates and enabled them as proficient CSE's in a short time. Also content developer and facilitator for MS Excel, Spotfire and Qliksense
  • Key player in the Business Process Re-engineering Project for re-designing the Spotfire tool for clinical data and analytics team in GDD. Supported and contributed along with other stakeholders CDD, CDDRA and CSE team in identifying the gaps in the existing process, redesigning and implementing the new process for the tool. Also, a coach and content developer for training modules in Up4Growth and in CSE team
  • Built new capabilities in MS teams to drive NOVOPEX (in collaboration with GDD India Learning and Regional Head) and GH-LAB (in collaboration with Global Program Head) site level initiatives, which enabled >500 associates to develop capabilities around new tools, technology and methodology to drive operational excellence & efficiency and to gain end to end knowledge in the clinical trial operations, including Yellow and Green lean Six Sigma Belt certifications during the COVID times 2020-21
  • Self-learnt Qliksense tool knowledge enabled me to address the unaddressed business problem in the team. Basic clinical data review app developed by me along with the SME team helped the studies which can't be onboarded on to Spotfire and studies which have different vendor databases. We are evolving and finding new Apps to address most of key needs in the team. Also, developed the GDD India Strategy Dashboard in collaboration with GDD India Strategy Head on Qliksense
  • As a consultant, I have managed multiple stakeholders of multifunctional teams from AAA organization to align with Novartis during the AAA transition project. I have played a key role in maintaining the project charter, regular meeting with key stakeholders for the updates and getting the work done as per timelines. Also been part of the impact assessment for few tasks which has missed the predefined timelines.
  • In the previous organization, I have been involved in lean the scientific writing team process through Six Sigma process. This process improved the efficiency and performance of the team based out in different locations in India and won the Best Team Award for the Quarter for the extraordinary performance

Overview

14
14
years of professional experience

Work History

Clinical Scientific Expert II

Novartis
09.2020 - Current
  • Currently supporting Renal Metabolic studies in IGAN, C3G and LN disease areas
  • Identified issues, analyzed information and provided solutions to problems.
  • Organized and detail-oriented with a strong work ethic.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Developed strong communication and organizational skills through working on group projects.
  • Passionate about learning and committed to continual improvement.
  • Demonstrated creativity and resourcefulness through the development of innovative solutions.
  • Got an opportunity to work like a CDD as team reformed (CDD, CDMD and GTD changed) just 2 months prior to the database lock and successfully locked the phase 2 study- CLNP023X2202 prior to the timeline. Implemented eNarratives technology for this study CSR
  • Collaborated with multifunctional teams for compilation of program level regulatory document-Investigator brochure, DSUR and PSUR and released prior to the timeline
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Contributed to synopsis, protocol development, informed consent forms, case report forms, Informed consent forms, End point management plan for adjudication, DTS, DQP for clinical sections, DQPM, PD specifications, CSR and CSR narratives
  • Developed materials and presented at Investigator meetings for two studies
  • Identified and aligned the team on all DM related activities and reviews; revised DQPM, DQP, ECS accordingly to avoid any overlaps in the data validation and reviews
  • Handled multiple deadlines for eight different studies from the time I have joined the CSE group with all deliverables being met on time without a compromise on quality and sometimes even before hand by close collaboration with data operations, safety, trial management, CRA’s and sites
  • Independently handled the entire clinical review as per DRP and protocol deviation review and the report archival for phase 2/3 studies of LCZ/LNP without any supervision from CDD for phase 2/3 studies of LCZ/LNP
  • Working on streamlining PD process for phase 2 LNP study in RaveX by conducting meetings with relevant stakeholders, identifying important vs non-important PD’s to adapt the new PD process and tools, implementing the new guidance’s for COVID 19 PD’s and training FM/CSM’s on new guidance in CO calls
  • Representing clinical function on SOP development for data validation and review, third party reconciliation
  • Serving as a SME for Spotfire and Excel for CSE group
  • Self learnt a new data visualization tool Qliksense and innovated an App for identifying clinical trends from trial data which is applicable for most of the Rave studies. Currently serving as a SME and re-designing robust App for interpreting trends and patterns

Minisabbatical In GDD India Strategy Team

Novartis
05.2020 - 03.2021
  • Written summary of the various functions in the GDD team in collaboration with the LT and senior LT members for SEIS
  • Designed GDD India Strategy Dashboard App on Qliksense for GDD associates. This includes all site level initiatives in GDD
  • Maintained timely data refresh of the initiatives in collaboration with leads
  • Planned and implemented Novopex initiative in collaboration with GDD India
  • Strategy head and GDD India Learning and Regional Head, for upskilling GDD associates with project management tools and methodologies. This initiative was very successful and over hundreds of associates benefited from this
  • Cultivated interpersonal skills by building positive relationships with others.
  • Supported as a PMO partner for AAA integration project
  • Maintained AAA project charter on MS projects and collaborated with different cross functional teams through regular Working meeting on project updates and deliverables
  • Proven ability to learn quickly and adapt to new situations.
  • Proved successful working within tight deadlines and a fast-paced environment.

Clinical Scientific Expert I

Novartis
10.2015 - 08.2020
  • Performed high quality clinical data review and identified clinical data insights through patient level review and trends analysis through Qliksense, Excel and Spotfire, supported Interim Analysis, DMC, Database and Post Lock activities and facilitated resolution of clinical data issues
  • Collaborated with different stakeholders of cross functional teams to enhance quality of data review with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
  • Led the CSR narrative activity from clinical until it’s finalization for phase 2 LCZ/LNP studies
  • Handling the activity independently without any supervision from the kickoff meeting
  • Worked extensively along with data management from ICON to meet study DBL being a liaison between clinical and DM
  • Addressed and provided resolution to several issues with erudite DM knowledge and experience in regular DRT and CTT meetings
  • Implemented strategy to create a positive competitive spirit among sites for 100% data entry and quality, this increased the productivity and aided to accomplish the study milestone database lock for LCZ/LNP studies
  • Identified trends with questionnaires data and the learnings were implemented in phase 2 to avoid reoccurrence of similar issues
  • Mentored a new joiner with a different background to CSE role. The initial resilience was overcome by being more adaptable to his style of learning and flexible, which helped him in developing core competencies and understand the nuances of CSE role
  • As a lead CSE, transformed the team culture, re-established the team dynamics, implemented the processes and strategies efficiently, through leadership and collaboration with multifunctional stakeholders I enabled the team for more productivity which led the team to lock the database early
  • Self-motivated, with a strong sense of personal responsibility.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Innovated program report which includes key critical information from different clinical study domains in a single workbook in Excel, which reduced significant amount of time invested for the report generation and this report strategy was subsequently implemented as global reports which are now applicable for all clinical studies

Research Analyst (Scientific, Writer)

Thomson Reuter
02.2012 - 09.2015
  • Worked as a scientific writer, which included content development for abstracts and manuscripts for drugs, biologics and medical devices using > 175 Worldwide conferences data within timelines adhering to quality.
  • Applied effective time management techniques to meet tight deadlines.
  • Accountable for analyzing, interpreting, and reporting key information from clinical and preclinical study reports and data regarding early-stage chemical molecules
  • Represent the Thomson Reuters in scientific conferences and write overnight reports on recent developments on the drugs/new chemical entities/technologies and ensures the information availability in the Cortellis database within 24 h of the conference finish
  • Prepare clinical trial documents which include protocol summary, description, eligibility (inclusion and exclusion criteria), treatment summary, outcome data (safety, efficacy, pharmacokinetics, and pharmacodynamics) and locations/contacts using the company house style guidelines
  • Provide complete information of drugs and their safety profiles to the companies on the request
  • Perform in depth Pipeline Analysis of products in Research & development and contacting the companies for the same
  • Generate competitive intelligence reports on various products in preclinical and clinical stages
  • Prepare and analyze reports for different pharmaceutical companies which include R&D and marketed products portfolio
  • Data retrieval from scientific databases like clinicaltrials.gov, Science Direct, PubMed, Medline, BIOSIS
  • Managed a team of 8 members based in Hyderabad and Chennai. Responsible for the overall performance of the team
  • Mentored 5 new joiners and trained them in the databases and core writing skills
  • Developed and maintained courteous and effective working relationships.
  • Demonstrated respect, friendliness and willingness to help wherever needed.

Project Work

Hetero
01.2012 - 07.2012
  • Worked on the project entitled “Formulation and Evaluation of Extended-Release Matrix Tablets of Donepezil Hydrochloride by Wet Granulation Technique”, at Hetero Drugs, Jeedimetla from Jan 2012 to Jul 2012 under the guidance of Dr. Kamalakar Reddy, formulation R&D head, Hetero Drugs, Jeedimetla.
  • Adhered to industry practices, company standards and safety protocols in work.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Coordinated daily activity and flow of projects through multiple departments to verify on-time product delivery.
  • Modeled management and organizational skills and multi-tasked and prioritized in deadline-driven environment.

Project Work

Dr Reddy's
09.2009 - 10.2009
  • Worked on the project entitled “Qualitative and Quantitative Techniques for Drug Analysis” from Sep 2009 to Oct 2009 at Dr. Reddy’s Laboratory, Jeedimetla
  • Adhered to industry practices, company standards and safety protocols in work.
  • Verified quality of deliverables and conformance to specifications before submitting to clients.
  • Restocked inventory, completed cycle counts and assisted with full audits.
  • Completed assignments ahead of deadline.

Education

MBA - Healthcare Management

Indian School of Business
Hyderabad
06.2020

Master’s - pharmacy

JNTU University
Hyderabad
12.2012

Bachelor’s - pharmacy

Gokaraju Rangaraju College of Pharmacy
Hyderabad
06.2010

Skills

    Microsoft Project Expert

  • Subject Matter Expert
  • Scientific Writing
  • Critical Thinking
  • Collaborator
  • Innovation
  • Strategic
  • Empathetic
  • Curious
  • Decision making
  • Leadership

Accomplishments

  • Completed mini sabbatical in GDD India Strategy team.
  • Received Star awards for meeting the LCZ/LNP study timelines early, nominated by the CDD
  • Received applause awards and team awards for LNP study for various activities and achievements, nominated by CDD, CDMD and operational manager
  • Received Star awards for facilitating many CSE on Excel, Spotfire and Qliksense, nominated by peers
  • Trained > 100 CSE’s/CDD’s on Excel, Spotfire and Qliksense
  • Received Star award for leading and facilitating the GH-LAB site level initiative for Hyderabad, GV and Mumbai associates
  • Received keep glowing points from peers for designing the GDD India Strategy Dashboard on Qliksense
  • Enabled >500 associates to certify through GH-LAB and NOVOPEX initiatives
  • Written > 1000 scientific abstracts and 20 manuscripts from Worldwide conferences data
  • Received many star awards while working in Thomson Reuters for various activities
  • Received Best Team Award for the Quarter for the extraordinary performance of the team managed by me
  • Represented Thomson Reuters in "3rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials" held on October 27 to 29 2014 in HICC, Hyderabad and published a report in Cortellis
  • Published a paper on “Formulation and Evaluation of Rapidly Dissolving Buccal Patches” in International Journal of Pharmacy & Industrial Research under the guidance of Dr. Narasimha Rao, Principal, Holy Mary College of Pharmacy
  • Received academic award for being topper of the college in post-graduation.
  • Successfully organized Pulse technical fest during graduation
  • Won prizes in National level Students Technical Symposium for paper presentation

Key technical skills

  

  • Skilled in EDC tools-Novartis OC-RDC and RaveX
  • Knowledge in Argus and MedDRA
  • Skilled in Novartis CAT and ComPLeaT tools
  • Proficient in Microsoft office (Excel, PowerPoint, MS Projects and Access
  • Proficient in Data visualization tools like Jreview, Qliksense and Spotfire.

Timeline

Clinical Scientific Expert II

Novartis
09.2020 - Current

Minisabbatical In GDD India Strategy Team

Novartis
05.2020 - 03.2021

Clinical Scientific Expert I

Novartis
10.2015 - 08.2020

Research Analyst (Scientific, Writer)

Thomson Reuter
02.2012 - 09.2015

Project Work

Hetero
01.2012 - 07.2012

Project Work

Dr Reddy's
09.2009 - 10.2009

MBA - Healthcare Management

Indian School of Business

Master’s - pharmacy

JNTU University

Bachelor’s - pharmacy

Gokaraju Rangaraju College of Pharmacy

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Swathi Enugala