Jai Ramakrishnan
Principal Clinical Data Science Lead
Chennai,Tamil Nadu
Summary
Strategic-thinking project manager with several years of experience in budgeting and forecasting and risk management. Observant and resourceful professional dedicated to delivering project objectives within stipulated time, resource and budget constraints. Outstanding collaborator comfortable working with others in executing projects to achieve company objectives.
Focused and driven team player practiced in leading multiple simultaneous projects leveraging proven project management tools.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Principal Clinical Data Science Lead
ICON Clinical Research Private Ltd.
Chennai
09.2023 - Current
- Managed a team of Data Scientists in executing projects, ensuring deadlines are met and quality standards are maintained.
- Enhanced process efficiency and accuracy by implementing risk-based monitoring techniques utilizing RACT (Risk Assessment Categorization Tool) and ORIM (Operational Risk and Issue Management) for effective identification and mitigation of risks.
- Analyzed Coherence QC results, partnering with Quality Review team to identify error rate and implement effective strategies for mitigation.
- Meticulously reviewed the Data Management Plan on a recurring basis to guarantee its accuracy and relevance.
- Performed periodic reviews to ensure study files were uploaded and QC'd according to the File Management Plan.
- Collaborated with the clinical System Lead to provide inputs into clinical system development activities to ensure a robust data collection methodology and change management.
- In collaboration with the Clinical Data Science Program manager(CDS PM) forecast resources required for data delivery and manages study finances to ensure delivery within budget.
- Maintained effective communication with contract analyst to coordinate updates of contracts and timely submission of change orders for sponsor review.
- Proactively monitoring risk by tracking project status, implementing interventions to mitigate risks, and promptly addressing any issues that arise.
- Delivers to ICON and client Key Performance Indicators(KPI) and Key Quality Indicators(KQI).
- Conducted exploratory analysis on large datasets to identify patterns and trends, then communicated findings to stakeholders.
- Took an active role in SCRUM meetings, offering insights and suggestions for enhancement.
- Periodically reviewed unit tracker to ensure units were not overburned and resources recorded hours accurately
- Conducted lessons learned sessions post successful study lock and audits.
- Established effective communication channels between stakeholders and Data Science teams in order ensure successful execution of projects.
Project Manager, Data Management
ICON Clinical Research Private Ltd.
Chennai
10.2021 - 09.2023
- Established effective communication channels between stakeholders and Data Science teams in order ensure successful execution of projects.
- Conducted exploratory analysis on large datasets to identify patterns and trends, then communicated findings to stakeholders.
- Maintained records of all documents related to each project, including specifications, change orders, and invoices.
- Implemented effective communication protocols between internal teams working on different aspects of a given project.
- Developed and maintained project plans, timelines, and budgets.
- Manage the forecast and revenue recognition process by continuous review of monthly files and incremental review of project analysis file to meet departmental objectives for profit and margins.
- Summarized and prepared reports on project progress for executive leadership team.
- Collaborated closely with senior management on long-term strategic planning initiatives related to projects in development or execution stages.
- Conducted regular status meetings with internal teams and external partners to track progress against established milestones.
- Successfully coordinated resources from various departments and teams to facilitate project completion.
- Analyzed survey data, audit interviews, and focus groups to improve project decision-making.
- Participated in cross-functional teams responsible for developing innovative solutions for complex problems.
- Presented findings from data analysis in a clear, concise manner that was easily understood by stakeholders at all levels of the organization.
- Actively sought out feedback from stakeholders throughout the duration of a project in order to identify areas needing improvement or adjustment.
- Identified risks associated with each project and developed strategies for mitigating those risks.
- Communicated effectively with stakeholders to ensure project goals are met on time and within budget.
- Forged strong partnerships with various teams, vendors, and contractors.
- Facilitated collaborative meetings with diverse stakeholders, including internal team members, sponsor, and vendors.
- Scheduled and monitored project timelines, personnel performance, and cost efficiency for improved forecasting.
- Developed, implemented, and administered change orders as well as various contractual modifications that influenced budget allocation and project timelines.
- Drove continuous improvement of the project delivery process by providing strong leadership.
- Developed solutions to project risks and issues, meeting quality and timeline goals and objectives.
- Submitted project deliverables to clients, consistently adhering to quality standards.
Senior Clinical Data Lead
ICON Clinical Research Private Ltd.
Chennai
04.2020 - 10.2021
- Monitored all study activities from start-up to closeout.
- Spearheaded the development of CRF specifications (ALS), edit check specifications, UAT plans and summary reports, in addition to data transfer and listing programming specifications during study initiation.
- Participated in user acceptance testing activities prior to implementation of new systems or processes.
- Provided guidance and support for other members of the Clinical Data Management team.
- Identified and addressed discrepancies between source documentation and clinical data sets.
- Tracked changes in regulations affecting the collection, storage, and use of clinical data.
- Collaborated with clinicians and research staff to develop processes for collecting high-quality clinical data.
- Ensured compliance with regulatory requirements pertaining to collection, storage, and use of clinical data.
- Generated dashboards to visualize trends in clinical trial results.
- Shared reports for statistical analysis on clinical trial results to assess safety and efficacy of treatments.
- Provided training sessions on best practices related to the management of electronic medical records.
- Reviewed study protocols for completeness, accuracy, consistency, and clarity.
- Developed and implemented a data transfer specification to extract required data, critical variables from the integrated system like IRT, and from vendor database like eCOA.
- Monitored progress against key performance indicators related to quality control measures for incoming datasets.
- Developed data management plans and reports, validation procedures, and CRF completion guidelines.
- Developed internal procedures for organizing and filing clinical data to enhance workflow efficiency.
Clinical Data Lead
ICON Clinical Research Private Ltd.
Chennai
07.2015 - 03.2020
- Lead Data Management point of contact for day-to-day activity on the study, overseeing and coordinating tasks delegated to the study team members, both locally and in other offices.
- Lead the development of specifications, implementation, testing of e-CRF or paper CRF edit checks and data review, overview listings.
- Leads development of Data Management Plan and Study Specific Procedures, including control of distribution and team training on SSPs.
- Ensure standard metrics and status reporting are set and maintained in the study.
- Set up and maintain DM files, ensuring they are audit ready.
Clinical Data Lead I
ICON Clinical Research Private Ltd.
Chennai
04.2014 - 06.2015
- Delivered Lesson Learned presentations on audit findings from ongoing projects.
- Created reports to track performance metrics and ensure compliance with internal policies.
- Lead the development of specifications, implementation, testing of e-CRF or paper CRF edit checks and data review, overview listings.
- Leads development of Data Management Plan and Study Specific Procedures, including control of distribution and team training on SSPs.
- Ensure standard metrics and status reporting are set and maintained in the study.
- Set up and maintain DM files, ensuring they are audit ready.
Associate Clinical Data Lead
ICON Clinical Research Private Ltd.
Chennai
11.2012 - 03.2014
- Assisted in developing data management plans for assigned studies, including database design specifications.
- Coordinated resolution of discrepancies identified during medical coding processes.
- Participated in user acceptance testing activities prior to the database lock process.
- Collaborated with internal teams, such as biostatistics, programming, and regulatory affairs, when necessary.
- Provided guidance to junior staff members on various aspects of clinical trial conduct and data management processes.
- Interfaced with external vendors to ensure successful transfer of files between sponsor, CRO sites, and vendor sites.
- Ensured that all queries related to missing or discrepant study data were addressed promptly and effectively.
- Conducted training sessions for new employees on various aspects of the clinical trial process.
- Reviewed and monitored clinical data for accuracy, completeness, and compliance with protocol requirements.
- Compiled data to enter necessary information into appropriate databases.
- Developed procedures for organizing and filing clinical data to enhance workflow efficiency.
Clinical Data Coordinator II
ICON Clinical Research Private Ltd.
Chennai
08.2010 - 11.2012
- Reviewed source documents for discrepancies between collected data and entered information into database.
- Prepared presentations outlining key findings from completed studies.
- Identified potential issues related to data accuracy and integrity.
- accurately and consistently apply data handling conventions to Case Report Forms, as necessary, in accordance with all applicable procedures.
- Perform Quality Reviews and appropriately address all issues.
- Compile and distribute necessary study documentation, and maintain accurate and complete study files in accordance with all applicable procedures.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual check/listings.
- Appropriately address responses to data queries, and accurately update the clinical data as necessary.
- Identify and accurately resolve all workflow or clinical data discrepant issues.
- Assist with the development, review, and update of relevant data management study-specific procedures.
- Accurately perform Serious Adverse Event reconciliation. In accordance with all applicable procedures.
Clinical Data Coordinator I
ICON Clinical Research Private Ltd.
Chennai
07.2008 - 08.2010
- Accurately and consistently apply data handling conventions to Case Report Forms, as necessary, in accordance with all applicable procedures.
- Perform Quality Reviews and appropriately address all issues.
- Compile and distribute necessary study documentation, and maintain accurate and complete study files in accordance with all applicable procedures.
- Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual check/listings.
- Appropriately address responses to data queries, and accurately update the clinical data as necessary.
- Identify and accurately resolve all workflow or clinical data discrepant issues.
- Assist with the development, review, and update of relevant data management study-specific procedures.
- Accurately perform Serious Adverse Event reconciliation. In accordance with all applicable procedures.
Query Quality Assessor
Accenture Services Private Ltd
Chennai
11.2007 - 06.2008
- Coordinate with Team Leads to identify the patients for which quality check is performed.
- Perform quality reviews for all data entry and data cleaning resources, and document findings. Submit the findings to respective Team Leads, and Quality Compliance Lead for follow-up.
- Oversee the coordination of data management operations and project deliverables, ensuring productivity and quality are in line with overall functional expectation.
- Facilitate and present topics at internal meetings.
- Accurately estimate time needed to complete tasks within project timelines.
- Coordinate work among team members and liaise with internal and external contacts.
- Implementation of OPEX and various quality improvement processes.
- Provides interpretation of GCP regulation, guidelines, policies, and procedures, and provides sound guidance to team members.
Clinical Data Associate
Accenture Services Private Ltd
Chennai
02.2007 - 10.2007
- Provided technical guidance and training on EDC system usage within team members.
- Collaborated with research staff to develop case report forms.
- Provided support for electronic data capture systems.
- Participated in user acceptance testing sessions for EDC system upgrades.
- Tracked key performance indicators, such as enrollment rate and site activation time, for assigned studies.
- Maintained up-to-date knowledge on relevant regulatory requirements pertaining to clinical trial conduct and documentation standards.
- Facilitated communication between internal teams regarding clinical trial design and implementation strategies.
- Assisted in developing processes to improve efficiency of data collection, entry, review, and reporting.
- Ensured compliance with applicable regulations and guidelines in all aspects of clinical data management.
- Retrieved historical records from archives as needed for research purposes.
- Developed and maintained databases for the collection, storage, retrieval, analysis, and reporting of clinical trial information.
- Generated queries related to discrepancies in protocol deviations, or missing and incorrect values in the database.
- Coordinated with external vendors providing services related to clinical trial activities.
ISO Executive
Value Added Corporate Services Private Ltd.
Chennai
06.2006 - 01.2007
- Organized and facilitated regular meetings with senior management teams.
- Led initiatives to improve customer service levels throughout organization.
- Created and maintained relationships with key stakeholders.
- Created reports summarizing progress against organizational goals and objectives.
- Developed and implemented strategies to increase executive efficiency.
- Delegated work to staff, setting priorities and goals.
- Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
- Improved productivity initiatives, managing budgets and accounts, coordinating itinerary and scheduling appointments.
- Created effective business plans to focus strategic decisions on long-term objectives.
- Used excellent verbal skills to engage customers in conversation and effectively determine needs and requirements.
- Reviewed QMS documents such as Quality Manuals, Procedures, Process Flowcharts, for accuracy and completeness.
- Assisted in the development of action plans to address deficiencies found during internal audits.
- Evaluated effectiveness of risk management measures taken by the organization.
- Documented audit results in accordance with established standards and procedures.
- Identified areas of improvement within the organization's quality management system.
- Performed detailed audits of management systems and identified any potential risks or issues.
- Maintained a database of records related to ISO certifications and audits conducted.
- Developed internal audit plans and schedules for all departments.
- Provided training sessions on topics related to ISO standards for staff members.
- Ensured that all company personnel were adhering to applicable laws, regulations, codes of practice, standards, policies and procedures.
- Conducted gap analysis to identify areas of non-conformance with ISO standards.
- Provided guidance and recommendations on corrective actions needed to comply with ISO requirements.
- Attended external audit reviews and provided support whenever required.
- Monitored progress against corrective action plans as part of follow up activities.
- Collaborated with other stakeholders to ensure that corrective actions are implemented effectively.
- Participated in meetings with department heads to discuss findings from internal audit reports.
- Reviewed and analyzed processes, procedures, policies, and documentation related to ISO compliance.
- Verified that processes were being followed according to documented procedures.
- Assisted senior auditors in conducting special investigations into suspected violations or frauds.
- Analyzed data gathered during internal audits and prepared comprehensive reports detailing observations, conclusions, and recommendations.
- Performed audits of operational and financial areas to check compliance.
- Collaborated with external partners to complete audits.
- Coordinated project materials and schedules, facilitated communication and prepared reports.
- Liaised with auditors to complete annual audits and maintain compliance with local, state and federal requirements.
Education
Master of Science - Biotechnology
SRM Institute of Science & Technology
Chennai04-2005
Bachelor of Science - Microbiology
Alpha Arts And Science College.
Chennai03-2002
Skills
- Project Planning
- Procedure Development
- Inventory Control
- Compliance Monitoring
- Work flow planning
- Vendor Sourcing
- Resource Allocation
- Productivity Improvement
- Document Management
- Schedule Management
- Financial Administration
- Project Management
- Risk Management
- Contract Management
- Agile Methodology
- Root Cause Analysis
- Data Analysis
- Project tracking
- Project development
- Client Relations
- Quality Management Systems
- KPI Tracking
- Contract Administration
- Operational Excellence
- Team Training
- Internal Auditing
Therapeutic Area Exposure
Neoplasms Benign, Malignant and Unspecified - Breast Cancer Phase III Study, Brain Metastases from Lung Cancer Phase III Study, Lung Cancer Phase III Study.
Endocrinology - Type 2 Diabetes Phase IV & Phase III Study.
Central Nervous System - Epilepsy Phase III Study.
GIT - GERD Phase III Study.
Cardiovascular - BPH Phase III Study.
EDC Database Experience.
Oracle Clinical, Medidata Rave, InForm & Clintrial
Languages
Tamil
First Language
English
Proficient (C2)
C2
Accomplishments
- Received many awards for successful completion of Database lock, prior to the scheduled timelines.
- Awarded for demonstrating leadership qualities.
- Recognized for mentoring and training the batch of new resources
Affiliations
- Active member of Neer Vanam initiative to restore lakes and regularly participate in the tree walk organized by Nizhal (NGO).
Certification
- Oracle9i-SQL&PL/SQL at NIIT.
- Trained in Operation excellence (OPEX).
- Completed Jira Application training and Agile project management courses in Coursera.
Timeline
Principal Clinical Data Science Lead
ICON Clinical Research Private Ltd.
09.2023 - Current
Project Manager, Data Management
ICON Clinical Research Private Ltd.
10.2021 - 09.2023
Senior Clinical Data Lead
ICON Clinical Research Private Ltd.
04.2020 - 10.2021
Clinical Data Lead
ICON Clinical Research Private Ltd.
07.2015 - 03.2020
Clinical Data Lead I
ICON Clinical Research Private Ltd.
04.2014 - 06.2015
Associate Clinical Data Lead
ICON Clinical Research Private Ltd.
11.2012 - 03.2014
Clinical Data Coordinator II
ICON Clinical Research Private Ltd.
08.2010 - 11.2012
Clinical Data Coordinator I
ICON Clinical Research Private Ltd.
07.2008 - 08.2010
Query Quality Assessor
Accenture Services Private Ltd
11.2007 - 06.2008
Clinical Data Associate
Accenture Services Private Ltd
02.2007 - 10.2007
ISO Executive
Value Added Corporate Services Private Ltd.
06.2006 - 01.2007
Master of Science - Biotechnology
SRM Institute of Science & Technology
Bachelor of Science - Microbiology
Alpha Arts And Science College.
- Oracle9i-SQL&PL/SQL at NIIT.
- Trained in Operation excellence (OPEX).
- Completed Jira Application training and Agile project management courses in Coursera.
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