Prathibha Prabhakaran

As the Associate Director of Neuroscience Therapeutic Area Clinical Data Sciences in India for Eli Lilly, I lead a department of 43 employees, including first and second-level reports. I am dedicated to delivering timely, high-quality data for data sciences at the enterprise level. My key responsibilities include:

• Collaborating with clinical leaders and stakeholders across departments such as statistics, clinical development, medical operations, monitoring, and investigator engagement to provide strategic insights that enhance clinical data operations, accelerating submissions and aligning with business priorities.
• Offering leadership and guidance to managers and senior managers on areas like people development, resource planning, and portfolio delivery.
• Ensuring seamless collaboration among various data science departments, including study build and programming, clinical data management, eCOA, medical coding, adjudication, and decommissioning.
• Driving operational efficiency and continuous improvement in Data & Analytics operations.
• Developing next-level leaders to strengthen Lilly's portfolio delivery.
• Representing the data organization at internal and external events.
• Providing business leadership and direction during inspections and audits.
• Leading enterprise-wide projects and innovations to achieve efficiency gains.
• Overseeing recruitment, development, and retention of talent in alignment with business needs.
• Building an agile organization to adapt to evolving portfolio requirements.
• Supporting staff development in areas such as drug development, therapeutic area science, project management, and clinical data management.
• Promoting a high-performance culture that fosters innovation, inclusion, and diversity.
• Ensuring the completion of decommissioning operations for Lilly trials and systems in compliance with business and regulatory requirements.

Key Achievements:

• Successfully led data science operations, driving data delivery and accelerating submission for Kisunla Approval.
• Recipient of the 2024 Quality Pinnacle Award for Leadership & Impact, enhancing the quality of Lilly’s drug discovery and development.
• Winner of the Lilly Innovator Award for Q2, 2024.
• Established a high-performing, self-sufficient clinical data sciences team at Eli Lilly in Bangalore, India.
• Created and developed new business opportunities, such as the Data Strategist role in the Indian region.
• Established a fully functional, end-to-end clinical data sciences team in India.
• Held 1-1 interactions and business lunches with CEO Dave Ricks.
• Represented LCCI Clinical Data Sciences at the Integrating Women Leadership Conference in Indianapolis.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.

Enterprise Leadership on the following

• Risk Based Quality Management for Eli Lilly
• Enterprise level automated & Standard metrics projections for clinical trials in Lilly
• Query reduction project to facilitate faster data base locks
• Capacity Generations through AI mediated SAE reconciliation
• Promote Lilly as a preferred sponsor of choice for HCPs and sites by Simplified CRFs and Direct Data capture technology options and optimizing clinical data Standards for efficiency gain.
• Digital Libraries for Critical data and critical process
• PI signature compliance methodologies for EMEA regulations compliance.
• AI mediated External data reconciliation solutions
• Co-Chair for Leadership development for Supervisors through Supervisors Core Academy
• Certified EQO meter trainer for Clinical Data Sciences in Eli Lilly.
• Global sDnA magazine -YUGMA

As the leader of the neuroscience data operations team at Eli Lilly in Bangalore, my key responsibilities included:

• Overseeing the timely delivery of high-quality data for the Neuroscience therapeutic area.
• Supporting the Global Senior Director of Neuroscience TA in strategic planning and business prioritization.
• Fostering people development within the Data Sciences department at LCCI, Bangalore.
• Leading innovation and optimization projects from a business leadership perspective for Lilly.
• Facilitating cross-functional collaboration across various stakeholder teams within Lilly.
• Directing the data function in planning and executing inspections and audits.
• Ensuring the development of people leaders to drive business efficiency.

Key Achievements:

• Led and implemented global automated enterprise-level metrics projections for clinical trials at Lilly.
• Established a central team for system decommissioning and archival at LCCI, Bangalore.
• Recipient of the prestigious LRL President’s Award for 2022 for leadership in Alzheimer’s Compound data science operations.
• Winner of the WE-Lead (Women Leadership Forum) award for outstanding leadership.
• Developed a high-performing team at LCCI, Bangalore.

As one of the Poineering members of the Clinical Data Science department at Eli Lilly, my primary responsibilities included:

• Establishing the clinical data sciences function in Bangalore, India.
• Recruiting qualified candidates for various clinical data science roles.
• Transitioning clinical data operations for neuroscience trials from CROs to an in-house model.
• Adapting processes to align with the new in-sourced model of clinical data management.
• Managing the transition of decommissioning responsibilities from CROs to an in-house team and building a dedicated team for this purpose.
• Facilitating people and competency development to align with Lilly's corporate center data sciences unit in Indianapolis.

Achievements:

• Recipient of LRL Presidents Award from CEO for 2021
• Established the Clinical Data Sciences function at Lilly's Bangalore office (LCCI), growing the team to over 200 clinical data science professionals.
• Successfully insourced clinical data management for neuroscience trials, transitioning from the TPO to an in-house model.
• Established a dedicated unit for decommissioning and archival operations at LCCI, Bangalore.
• Shifted the business operation model for clinical data sciences from an outsourced to an in-house structure.

I managed a team of 12 individuals responsible for Trial Closure vendor management, DM deliverables for Module 5 in eCTD during global regulatory submissions, Clinical Study Report DM deliverables, and Site & Sponsor archives for all Novo Nordisk trials. Additionally, the team handled CRF design, creation of CRF standards for non-interventional trials, test plan creation for validation checks, and PRO questionnaire design in collaboration with the Health Economics team. My key responsibilities included:

• Overseeing project planning and associated tasks throughout the trial lifecycle (from trial outline to submission).
• Ensuring a robust quality management system and organizational effectiveness within the team and unit.
• Promoting people development and engagement within the team and data management unit.
• Facilitating knowledge exchange within Data Management and externally through participation in relevant national and international societies.
• Managing resource planning and allocation.
• Ensuring high-quality, on-time deliverables from team members.
• Fostering competency development within the team.
• Ensuring compliance with Novo Nordisk's Quality System and SOPs.
• Maintaining team engagement and motivation, contributing to a cooperative and collegial atmosphere within the department.
• Driving continuous improvement in workflows and processes.
• Leading recruitment, termination, and personnel transfer processes, providing input to the Head of Department/Director.
• Leading cross-department efficiency initiatives and fostering therapeutic domain knowledge.
• Ensuring the team’s readiness for inspections.
• Enhancing team performance and potential through feedback and coaching to meet departmental goals.
• Collaborating with the Head of Data Management/Director to identify relevant training and conferences (national and international) to enhance skills and capabilities.
• Assisting the Head of Department/Director in financial planning and budget estimation.
• Collaborating with HQ counterparts and CROs on key discussions, such as competency development, trial forecasting, and issue resolution.
• Hosting and contributing to best practice discussions within the department.

Achievements

• Developed the team to take over the post DBL process from end –to-end.
• Widened the scope of business within the team for submission readiness of CDISC deliverables.
• Responsible for multiple FDA/PMDA inspections for DM submission readiness.
• Responsible for DM deliverables for multiple BLA, MAA and 120 days safety updates to Authorities.
• Identified, mapped, executed and developed new business opportunities.
• Developed a Quality mid-set team.
• Steering committee member of global submission focus team.
• Project manager for Process improvements between Regulatory affairs and Data Management.
• Process expert for DM deliverables for regulatory submissions.
• Achieved a score of 100% in employee satisfaction survey for people managers.

As a team leader I handled a team of 12-16 people who are responsible for CRF Designing, DM deliverables for module 5 in eCTD during global regulatory submissions, Clinical Study report DM deliverables and Sponsor archives for all Novo Nordisk trials. My main responsibilities were

• Manage the team according to the Novo Nordisk policies and develop employees and the team to meet Novo Nordisk business needs.
• Resource allocation and resourcing keys
• Manage the unit/ team according to the Novo Nordisk Way to meet the team as well as DM dept. and Novo Nordisk’ business needs.
• Ensure quality deliverables for coding, CRF Design and regulatory submissions.
• Ensure continuous improvement and quality mind set with focus on compliance
• Set targets for the team according to the overall strategies for DM department.
• Follow up on team deliverables ensuring timely, high quality and cost-effective outcome.
• Ensure optimal and flexible use of resources in the team, timely identification of resourcing gaps and the consequences, identify possible solutions.
• Support recruitment, termination and warning process, and transferral of personnel to other departments.
• Planning and making contributions to department meetings and contribute to the general information flow within the department.
• Provide input to department budget e.g. travel and courses.
• Provide input to outsourcing requirements for data management.
• Ensure excellent quality management system within team.
• Ensure people development and people engagement within team.
• Feedback & performance management for employees.
• Provide process support and guidance to the team.
• Develop and maintain Novo Nordisk culture and values in the team.

• End to end project management for large clinical trials.
• Project planning in collaboration with Trial Management team.
• Training of Investigators and Monitors.
• Risk analysis and management.
• Represent Data Management in Investigators & Monitors, International Study Group Meetings.
• Ensure that the timelines of all the deliverables are met, keeping quality as a priority.
• workload projections and resource management
• Provide technical assistance to team members for study issues
• Understand and meet stakeholder requirement
• Ensuring quality of data and processes within and across projects.
• Planning and execution of DM timelines during startup, conduct, close-out starting from trial outline to CTR.
• Handle escalations, perform root cause analysis and provide corrective and preventive actions.
• Chairing Data Quality Review meetings and Data Base Lock Meetings.
• Alignment of processes across the clinical trials within Projects.
• Vendor Management.
• Contract Reviews.
• Global project team management.
• Ensuring Audit/inspection readiness of the project team
• Ensuring the project/trial level documentations are up to date
• Trainings for Data Management Department.
• Review of standard operation procedures (SOPs).
• Preparation/review of key data management Documents like Blinding plan, Data Handling protocols (DHP/DMP), mock eCRF, eCRF Specification, edit check specification, UAT Plan, Interface Mapping Documents, Lab Specifications and Annotations, Trial Validation Plan, Data Flow Plan, Data Handling Decisions, QC Documents, Data Base Lock Minutes etc.

Achievements

• Project manager for multiple large-scale complex trials.
• Successfully handled one of the most complex trials in the organization.
• Part of the global team defining blinding requirements for clinical trials for Novo Nordisk.
• Reviewer for multiple DM SOPs and guidelines and Data Management Standards.
• EDC super user for Inform platform for Data Management representing Indian data management operations.
• Data Management representative for GCP audits for multiple projects.
• Mentored many new joiners on Data management practices and NN way of working.
• Represented DM in multiple international meetings.
• Successfully trained monitors and investigators across the globe on project specific DM set up and conduct of trials.
• Global committee member for implementation of CDISC standards in novoNordisk.

• Project Management
• Vendor Management
• Global project team management
• Project planning.
• Trial Planning during trial conduct and trial Closure
• Co-ordination of clinical data with various departments in clinical trial.
• Project related documentation for auditing.
• Review and preparation of project/trial specific documents and contracts in start-up, conduct and close-out period.
• Training investigators and monitors in data management aspect of the trial.
• Risk Assessment.
• Work allocation for resources.
• Data Base lock.
• Discrepancy management.
• Mentoring team members.
• Managing the trial team.
• End to end planning to ensure a smooth study process till CTR finalization.
• Responsible as face of DM AUDITEE during an audit for the allocated studies.

• Project Management
• Perform trial planning, trial set up and trial execution on DM issues on a level that secures data is collected and validated in the clinical database before data analysis in a timely manner and to the right quality level.
• Co-ordination of clinical data with various departments in clinical trial
• Project related documentation for auditing.
• Preparation of project related documents.
• Co-ordination with external vendors for data transfer.
• Preparation of data management plan (Data flow Plan)
• Communication with monitors
• Training investigators and monitors in data management aspect of the trial.
• Risk Assessment.
• Mentoring new joiners.
• Knowledge sharing through share better practice sessions
• Discrepancy Management
• Preparation of Edit check specification.

Achievements

• Single handedly performed data management activities for many trials.
• Represented Data Management team in international investigators and Monitors meetings.
• Reviewer for multiple DM SOPs.

• Co-ordination of clinical data with various departments in clinical trial
• Discrepancy Management
• Project related documentation for auditing.
• Preparation of project related documents.
• Co-ordination with external vendors for data transfer.
• Preparation of data management plan (Data flow Plan)
• Communication with monitors
• Training investigators and monitors in data management aspect of the trial.
• Operational Specialist (May 2011 to Oct 2011)

Special Projects:

• Member of CRF standardization group for Inflammation therapeutic area in NovoNordisk. (2011-2013)
• Member of reference group for cross functional area project –for standardization of EDC UAT in NovoNordisk. (2011-2013)
• Member of CDISC international implementation Group for Novo Nordisk.(2014-2017)
• Member of global Blinding committee for Novo Nordisk (2015-2016)
• Core committee member for Novo Culture focus group (2019-Till Date)

Quintiles is a pharmaceutical service provider headquartered out of North California, USA and is one of the largest pharmaceutical service provider, which has operations in more than 60 countries.

• Serve in the role of back-up to a Data Operations Coordinator or Data Team Lead.
• Resource management and work allocation within the team
• Trial start up processes like
• eCRF design,
• Front end build
• User acceptance testing
• UAT documentation
• Local lab building (LNMT)
• Identifying DQRs
• writing test conditions and edit check specifications
• Providing specifications for listings and user acceptance testing in SQL developer.
• Trial Conduct processes which includes
• Discrepancy management in eCRf data
• ECG Data review
• DNA Data review
• Pharmacokinetic/Pharmacodynamic Data review
• Protocol deviation review
• IVRS Data review
• Lab review
• M-Protein Data Review.
• Mentoring team-members for an observed increase in performance
• Overall planning for project timelines and deliverables.
• Preparation and submission of documents for audit trial.

Key Achievements:

• Promoted to Clinical data coordinator with in 1.5 years based on consistent performance
• Two Years of extensive work experience with prestigious pharmaceutical clients.
• Extra effort Award for constantly meeting time-lines with 100% quality
• Applause award for outstanding performance.
• Appreciation from Internal & External clients
• Part of the team for 3 Successful data base locks in which one drug has been commercially launched in market and 2 are under FDA submission.
• Part of the team for 2 Interim data base lock for oncology studies.
• Single handedly built a data library for oncology (lymphoma and multiple myloma) studies to help the clinical data managers with data review.
• Single Point of contact for the entire project related matters for the client.
• Special achievement award for outstanding performance.

• Visiting lecturer of Human Genetics

Jubilant Biosys is an integrated discovery collaborator to major pharmaceutical and biotech companies, accelerating global discovery efforts across multiple therapeutic areas. Jubilant Biosys engages in a range of functional discovery services and shared risk collaborations with multiple global partners.Globally leveraged, Jubilant offers an integrated and collaborative platform of drug discovery and development services to the global pharmaceutical industry.

Role & Responsibilities:

• Overlooking the curation and quality check done by designated persons.
• Quality Check of papers that came out of curation.
• Delivery of the product in UNIX format.
• Uploading of mined data to the ftp site of CAS.
• Training of new joiners in the field of cancer research, biotechnology, pharmacology, microbiology, biocomputing, bioinformatics and also in the aspect of curation and GLCV