Lakshmi Ramachandra
Bangalore
Summary
Dynamic Associate Manager at Fortrea with a proven track record in resource allocation and team building. Expert in data analysis and performance management, I have successfully led initiatives that improved process efficiency and enhanced staff training programs, fostering a high-performing team culture. Committed to delivering quality results in clinical data management.
Overview
18
18
years of professional experience
Work History
Associate Manager
Fortrea (Formerly Labcorp)
Bangalore
05.2021 - Current
- Responsible for the line-management of Data Management staff. Manage direct reports to ensure staff training records are up to date and utilization targets are met or exceeded, per job grade, and manage performance reviews and issues of direct reports.
- Be an active member of the Data Management Leadership team and cascade relevant information from internal and external meetings to direct reports and appropriate colleagues.
- Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.)
- In conjunction with the Lead Data Manager, provide input into assessment of resource requirements on a regular basis.
- Maintain a comprehensive understanding of Covance Data Management SOPs, Work Instructions (WI) and guidance documents, possess knowledge of all other CDS procedural documents that impact Data Management and assist with the generation and review of SOPs, WIs, etc., when required.
- Accountable for selection, training, development, and performance management of employees and interns.
- Accountable for resource and utilization management, budget spend and delivery aligned to project scope.
- Provided line management and technical support to assigned project leaders.
- Line management responsibilities for the training, development, and performance review of assigned staff. Drives the assignment of staff to understand and perform consistently according to defined operational, financial, and quality performance and process standards.
- Provided mentorship to more junior colleagues to nurture professional growth.
- Leading internship program, which involve interviewing college final year students and selecting best among them who exhibits adaptivity to corporate culture, hire them, prepare robust training plan, train them and support them until they are onboarded.
- Assesses project management competencies for assigned staff in order to create developmental plans that will increase competencies and close performance gaps.
- Lead initiatives like DMR process improvement, quality process improvement
- Build and maintain good Data Management relationships across functional units.
- Demonstrate role specific Competencies and company Values on consistent basis.
- Financial authority as it relates to personnel and projects.
- Accountable for developing high performing employees, ensuring employee and teams meet, core role, project and customer delivery directives and standards
- Heading fun committee from India location.
Associate Clinical Data Manager
Labcorp
Bangalore
11.2018 - 05.2021
- Review clinical trials data in accordance with [Global] Data Management Plans and applicable standardized data management processes (standard operating procedures, work instructions) to identify erroneous, missing, incomplete, or implausible data and run ancillary programs (example: special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- Generate, resolve, and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database. Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
- Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third-party vendor data (electronic case report form, electronic diary, specialty laboratory) and aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance), and/or data inconsistencies that require further investigation.
- Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved. Serve as a reviewer of project documents such as protocols, Case Report Forms (or electronic case report forms and electronic diary), monitoring conventions, Case Report Forms (electronic case report forms) completion guidelines.
- Assist with the development of [Global] Data Management Plans and Quality Management Plans that will deliver accurate, timely, consistent, and quality clinical data.
- Assist in the development of the clinical data model and/or database design and annotate the Case Report Form (electronic case report forms) according to these specifications, the creation of data acquisition conventions and data review guidelines / edit check specifications consistent with the clinical data model, [statistical] analysis plans, and case report forms (electronic case report forms) completion / monitoring conventions and the development and testing of data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities
- Interact and collaborate with other project and specialty team members (clinical, programming, statistics, clinical data management, technical support, drug safety, et cetera) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Support the training of project staff on project-specific, global, standardized data management processes, maintain technical data management competencies via participation in internal and external training seminars and review literature and research technologies/procedures for improving global data management practices and perform other duties assigned by management.
Sr. Clinical Data Coordinator
Icon Clinical Research Docs Global
Bangalore
07.2017 - 11.2018
- Acted as lead for project and carried out activities providing management about the status of the study and was involved in analyzing the case report form inflow and resource management of study.
- Mentored study team members performed quality check on team members activity.
- Responsible for discrepancy management, providing study metrics and data reconciliation across electronic data capture tool.
- Raise manual queries in the system and ensure timely closure within turnaround time.
- Utilize logic and reasoning to identify misfiring edit checks which are not working and troubleshooting them and solve data related issues.
- Identifying issues/trends and communicating with study team, ensured assigned studies achieve deliverables.
- Execute Data Management activities (Data cleaning, Executing Manual & System Checks, Update relevant trackers).
- Adherence to Data review plan and client standard operating procedures, complete all mandatory training courses as applicable.
- Contribute significantly to process innovation and new initiatives, ensure zero client escalations.
CDAIII
PPD
Bangalore
04.2016 - 07.2017
- Performed all aspects of the data cleaning process, with minimal supervision and in accordance with good clinical practices and standard operating procedures.
- Key responsibilities are data listing reviews, reconciliation of Serious Adverse Events and third-party vendor data.
- Supported the Lead Data Manager by performing activities such as case report forms design, database design and Data Validation Manual creation.
- Performed initial review of data discrepancies and database updates.
CDAII
PPD
Bangalore
09.2014 - 03.2016
- Performed advanced aspects of the data cleaning process, with a high degree of accuracy and in accordance with good clinical practices and standard operating procedures.
- Key responsibilities were to perform initial review of data discrepancies and database updates, freezing, locking, user acceptance test, data listing reviews, lab normal ranges entry, preparation of memo to sites, preparation of Report Program Specification (RPS), reconciliation of Serious Adverse Events and third-party vendor data.
- Worked as a back-up CHARMED metrics preparation, importing, and exporting on Ds Navigator for all coded Takeda studies.
- Metrics preparation based on sponsor requirements.
- Worked on Inform (4.6, 5.5), Rave platforms.
Clinical Data Coordinator
IQVIA
Bangalore
03.2014 - 09.2014
- Performed all aspects of the data cleaning process, with minimal supervision and in accordance with good clinical practices and standard operating procedures.
- Key responsibilities are data listing reviews, reconciliation of Serious Adverse Events and third-party vendor data.
- Supported the Lead Data Manager by performing activities such as case report forms design, database design and Data Validation Manual creation.
- Performed initial review of data discrepancies and database updates.
- Worked as a Data Operations Coordinator (DOC) for multiple protocols, leadership role in multiple therapeutic area or process on a large study, served in the role of back-up to a Data Team Lead.
- Preparation of Data management plan documents, serious adverse event recon guideline and specifications, electronic case report, completion guidelines, EDIT spec updation
- Developed and tested databases and edit specifications, quality control of Resource activities.
- Guidelines and specifications related to studies, serious adverse event reconciliation, working on listings and updating log and coordinating according to sponsor specifications
- Metrics preparation based on sponsor requirements.
- Leading team member for handling team internal audits.
- Carrying out check on productivity utilization updates updated by team members.
- Key member of mentor team and handling DM mentoring activities for DOC/CDC and coordinating with study team members and proving deliverables on time
- External Vendor data reconciliation, working on vendor listings and updation of vendor log and raising queries wherever necessary, working on listings discrepant data identification, and issuing queries wherever necessary as per edit spec, query Management and maintaining action decisions log.
- Handled transfer validation activities for around 10 studies with 100% accuracy.
- Worked on Inform (Architect, 4.6, 5.5), Rave platforms.
Associate Clinical Data Coordinator
IQVIA
Bangalore
03.2013 - 03.2014
- Worked as a Data Operations Coordinator (DOC) for multiple protocols, leadership role in multiple therapeutic area or process on a large study, served in the role of back-up to a Data Team Lead.
- Served in the role of back-up to a Data Team Lead.
- Preparation of Data management plan documents serious adverse event recon guideline and specifications, electronic case report form completion guidelines, EDIT spec updating
- Developed and tested databases and edit specifications, QC of Resource activities.
- Worked on listings as per edit spec.
- Working on listings discrepant data identification and issuing queries wherever necessary as per edit spec, query Management and maintaining action decisions log.
- Mentored interns with DM activities.
- Worked on Inform (Architect, 4.6, 5.5), Rave platforms.
- Guidelines and specifications related to studies serious adverse event reconciliation working on listings and updating log and coordinating according to sponsor specifications, external Vendor data reconciliation working on vendor listings and updating of vendor log and raising queries wherever necessary.
Junior Associate
The Larvol Group
Bangalore
03.2010 - 05.2011
- Prepared MIR (Market Intelligence Report) for various indications like epilepsy, pain and oncology, inflammation for various clients.
- Individually handled MIR project for anti-cytokine for chronic autoimmune and inflammatory disorders such as rheumatoid arthritis (RA), Crohn’s Disease (CD) and psoriasis.
- Prepared FAM reports for oncology, pain, diabetes, and pipeline projects. Screening other FAM reports.
- Well versed with Clinicaltrials.gov, and other general sites that provide public information related to various indications.
Scientist
Connexios Life Science Pvt Ltd
Bangalore
10.2007 - 08.2009
- Well versed with Discover platform, PubMed, NCBI, Discover (tool used for analysis), LITMINER (tool used for selecting abstracts), MED (Tool used for understanding reactions between entities).
- Utilized translational biology as a platform and gained understanding of molecular network mechanisms underlying disease pathology and drug action.
- Conducted Metabolic and proteomic analysis of tissue samples obtained from clinical studies that helped to select targets, biomarkers & assays associated with clinical indications.
- Analyzed Diabetic conditions in mice and human samples through micro array data & developed conclusions on the dysregulated process.
Lecturer
Bangalore university
Bangalore
02.2007 - 10.2007
- Handled theory topics related to Immunology and hematology, Biotechnology and practical’s related to Biotechnological techniques, molecular biology, microbiological techniques.
Education
Master of Science (MSc) - Biotechnology
Bangalore University
Bangalore, Karnataka, IndiaBachelor of Science (BSc) -
Bangalore University
Bangalore, Karnataka, IndiaPost Graduate Diploma - PGDIPR
NLSIU
Bangalore, Karnataka, IndiaPost Graduate Diploma - Clinical Research
ICBio
Bangalore, Karnataka, IndiaSkills
- Resource allocation
- Team building
- Client communication
- Mentorship
- Process improvement
- Risk assessment
- Workload prioritization
- Data analysis
- Project management
- Employee training
- Quality control
- Performance management
- Staff management
Languages
English - ILR 3 (Professional Working Prof), Hindi - ILR 3 (Professional Working Prof), Kannada - ILR 3 (Professional Working Prof)
Therapeutic Experience
- Cardiology: Cardiovascular Coronary Artery Disease Coronary Artery Disease (CAD)-Phase III
- Oncology: Bone Cancer Bone-Phase IV Observational
- Human health: Obstetrics/Gynecology Gynecology/Women's Health Menstrual Disorder-Phase III
Timeline
Associate Manager
Fortrea (Formerly Labcorp)
05.2021 - Current
Associate Clinical Data Manager
Labcorp
11.2018 - 05.2021
Sr. Clinical Data Coordinator
Icon Clinical Research Docs Global
07.2017 - 11.2018
CDAIII
PPD
04.2016 - 07.2017
CDAII
PPD
09.2014 - 03.2016
Clinical Data Coordinator
IQVIA
03.2014 - 09.2014
Associate Clinical Data Coordinator
IQVIA
03.2013 - 03.2014
Junior Associate
The Larvol Group
03.2010 - 05.2011
Scientist
Connexios Life Science Pvt Ltd
10.2007 - 08.2009
Lecturer
Bangalore university
02.2007 - 10.2007
Master of Science (MSc) - Biotechnology
Bangalore University
Bachelor of Science (BSc) -
Bangalore University
Post Graduate Diploma - PGDIPR
NLSIU
Post Graduate Diploma - Clinical Research
ICBio
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