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Hi, I’m
Harshavardhan Lad
Senior Manager, Study Design and Programming
Mumbai,MH
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Summary
Versatile Senior Manager specializing in Clinical Study Design and Programming and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
19
years of professional experience
3
Certifications
3
Languages
Work History
Fortrea (Formerly known as Labcorp Pvt Ltd)
Sr. Manager, Programming
10.2021 - Current
Job overview
- Manage and mentor team of Lead EDC programmers on Early Clinical and Late Phase process
- Contribute to SME pool, Author/Contribute/Maintain process improvement plans, Author/Contribute/Maintain SOP/WI process
- Author/Contribute/Maintain Study and Process metrics
- Supervise, mentor, evaluate and aid in staff development, career development, interpersonal skills, achievement of competency standards
- Maintain quality and productivity standards of the team
- Assisting in development and execution of training programs for team and maintain compliance
- Lead/Support recruitment process
- Manage utilization and bill-ability of staff, planning for resource allocation
- Study Budget review/scrutiny/Analysis/ Participate in scope creation/update
- Oversee/Handle Quality events/CAPA actions for the department
- Closely work with Quality Assurance team on study Audits
- Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
- Implemented and developed operational standards, policies and procedures.
- Provided strong leadership to enhance team productivity and morale.
Labcorp Pvt Ltd
Manager, Study Design & Programming
01.2020 - 09.2021
Job overview
- To actively monitor staff projects quality, timelines and budgets to foresee and correct issues and ensure project expectations are met
- To work closely with lead designers and other programming staff to ensure efficient resource allocation and utilization
- Proactively lead, review, and amend departmental processes and documentation
- Facilitate technical expertise, share knowledge at department meetings, peer meetings, mentorship programs
- Handle Line management responsibilities
- Performance management, Conflict management, Cost management
- Encourage team for career growth and development
- Provides designer programming support and technical support to team members
- Lead/Participate in talent acquisition, job interview, Campus interview programs/workshops
- Lead/Oversee internship programs.
Covance Pvt Ltd
Sr. Clinical Applications Programmer
04.2019 - 12.2019
Job overview
- Working as a Tech Lead/SME for study designer team to standardized build and change control process
- Hands on expertise of building database, programming of dynamics and simple/Complex edit checks for both Veeva and Medidata Rave Responsibility of preparing the study setup related documents as per Company SOP’s such as eCRF specification and edit check specification
- Responsibility of coordinating with the Lead data managers for the discussion of timelines and study specific requirements
- Responsibility for configuration and implementation of EDC services within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data
- Follow CDASH compliance and Standard SOPs to deliver most accurate database structure Conduct Peer Review/Quality Control of study design for assigned projects
- Provide training to project staff on Project Specific/Global/Standardized processes and participate in internal and external training seminars and review literature and research technologies/procedures for improving global data management practices
- Work as a Trainer and provide process and study build training to new joiner, Conduct and lead knowledge sharing sessions.
Covance Pvt Ltd
Lead Programmer Analyst
10.2017 - 03.2019
Job overview
- Perform role of Lead Database Programmer/SME on a study Adherence to CDISC standards, work as Global Library standard specialist, SAE standard specialist, QC of clinical databases/eCRFs
- Contribute in SDS/DVS creation and review, Oversee Lab administration, Oversee Edit check programming, testing and maintenance, Custom function programming, testing and maintenance.
Chiltern Pvt Ltd
Sr. Programmer Analyst
03.2016 - 09.2017
Job overview
- Perform role of Lead Database Programmer, Custom function programming, eDiary/Lab/IvRS integrations review, testing and implementation via Batch Uploader
- Vendor coordination and management, Study Migrations, BOXI Report creation and maintenance, Sas listing/Checks/report testing/review/runs
- Database lock and unlock, Database Audit (Programming lead), Contribute in kick-off/eCRF/DVG review meeting
Chiltern Pvt Ltd
Programmer Analyst 2
01.2014 - 03.2016
Job overview
- Perform role of Lead Database Programmer (Medidata Rave), Close working relationship with study team especially Lead Data Manager and Project Manager, Designing clinical databases/eCRFs
- Testing, maintenance of clinical databases, Creation of annotated/blank CRFs, Edit check programming, testing and maintenance, Custom function programming
- SAS listing specification review and testing.
Chiltern Pvt Ltd
Programmer Analyst 1
10.2011 - 01.2014
Job overview
- Setting up clinical databases/eCRFs, Testing, maintenance of clinical databases, Creation of annotated/blank CRFs and Visit Casebook, Edit check programming, testing and maintenance BOXI Reports creation and maintenance, Creating data import / export and cleaning listing, Facilitate DM in database lock and unlock, archival, decommissioning
- Contribute in SDS/DVS creation and review.
Chiltern Pvt Ltd
Sr. Clinical Data Associate
07.2008 - 10.2011
Job overview
- Provide input and assistance in the production of Case Report Forms (CRFs) design in paper as well as EDC (Electronic Data Capture) studies
- Oversee in preparation of data entry guidelines, data management and cleaning plan, data cleaning listings
- Perform and lead discrepancy management in clinical database system
- Oversee and Facilitate Clinial Database testing activities, vendor management and vendor system testing activities
- Mentoring of CDAs within the department, Project co-ordination and management, Resource allocation/management.
Chiltern Pvt Ltd
Clinical Data Associate II
07.2006 - 07.2008
Job overview
- Track study progress for the relevant milestones and produce and evaluation monitoring, data clearing reports in the capacity of Clinical Data Manager Clinical data management and QC, Database testing and documentation, Archival and eTMF management Quality Control of specification and work performed by subordinates.
Siro Clinpharm Pvt Ltd
Associate Biometrician
01.2006 - 07.2006
Job overview
- Contribute to the design, maintenance, evaluation and implementation of study design through Clinial Database system in Oracle RDC systems
- Contribute to the program, maintenance, evaluation and implementation of edit checks through Clinial Database system in Oracle RDC systems
- Participate in review of various specifications used in the development of Clinical Database systems and also vendor systems.
Siro Clinpharm Pvt Ltd
Data Acquisition Specialist
01.2005 - 01.2006
Job overview
- Accountable for the clinical database set-up for electronic clinical data loading, and the timely, seamless integration of the electronic data into the database Accountable for the compliant and consistent implementation of lab and electronic data handling requirements as specified in the protocol
- Creates study specific electronic data format and handling specifications and documents and coordinates review and implementation of these documents with the SMT and data providers.
Education
CMC Ltd.Mumbai, Maharashtra
Diploma from Advanced Software Technology
Catalyst Clinical Research InstituteMumbai, Maharashtra
Diploma from Professional Diploma in Clinical Research
Medidata University – OnlineMumbai, Maharashtra
Medidata Rave Certified Study Builder
Medidata University – OnlineMumbai, Maharashtra
Medidata Certified Study Administrator
University of MumbaiMumbai, Maharashtra
Bachelor of Science (B. Sc) from Physics
Skills
Active Listening
undefinedDepartment
Study Design and Programming
Maritalstatus
Married
Company
Fortrea Pvt Ltd
Personal Information
- Date of Birth: 12/02/1979
- Nationality: Indian
Certification
Medidata Rave Certified Study Builder
Interests
Drive
Draw
Write
Spirituality
Accomplishments
Established team of Lead EDC Designers (Medidata Rave) in the organisation.
Authored and reviewed crucial SOP and WIs in the SOP revision of year 2023/24.
Established team of Lead EDC Designers (Veeva CDMS)
Devised budgeting and scope estimate strategy in the department.
Lead mentorship program in developing the first line of technical and process SMEs
Lead internship program and successfully acquired three interns in the candidate cases within the organisation.
Successfully maintained 0% attrition rate and 90% promotion rate with in the team for three straight years including Covid scenario.
Deliverable quality maintain in the range of 95%+ and utilisation of 85%+ through out.
Worked with CDM team to establish a common training philosofy for them and study design team together.
Consistent positive customer feedback and accolades from CDM adn sponsor teams for projects handled within the span.
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
HybridRemoteOn-SiteImportant To Me
Company CultureWork-life balanceCareer advancementHealthcare benefitsTeam Building / Company RetreatsFlexible work hoursWork from home optionStock Options / Equity / Profit SharingPersonal development programsSoftware
Medidata rave
Veeva CDMS
Veeva TMF
Veeva QMS
MS Project
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Marathi
Advanced (C1)
Timeline
Sr. Manager, Programming
Fortrea (Formerly known as Labcorp Pvt Ltd)
10.2021 - Current
Veeva Vault CDMS
08-2020
Manager, Study Design & Programming
Labcorp Pvt Ltd
01.2020 - 09.2021
Sr. Clinical Applications Programmer
Covance Pvt Ltd
04.2019 - 12.2019
Lead Programmer Analyst
Covance Pvt Ltd
10.2017 - 03.2019
Sr. Programmer Analyst
Chiltern Pvt Ltd
03.2016 - 09.2017
Programmer Analyst 2
Chiltern Pvt Ltd
01.2014 - 03.2016
Programmer Analyst 1
Chiltern Pvt Ltd
10.2011 - 01.2014
Medidata Rave Certified Study Builder
02-2011
Medidata Rave Certified Study Administrator
02-2011
Sr. Clinical Data Associate
Chiltern Pvt Ltd
07.2008 - 10.2011
Clinical Data Associate II
Chiltern Pvt Ltd
07.2006 - 07.2008
Associate Biometrician
Siro Clinpharm Pvt Ltd
01.2006 - 07.2006
Data Acquisition Specialist
Siro Clinpharm Pvt Ltd
01.2005 - 01.2006
CMC Ltd.
Diploma from Advanced Software Technology
05.2002
Catalyst Clinical Research Institute
Diploma from Professional Diploma in Clinical Research
05.2012
Medidata University – Online
Medidata Rave Certified Study Builder
05.2011
Medidata University – Online
Medidata Certified Study Administrator
05.2011
University of Mumbai
Bachelor of Science (B. Sc) from Physics
05.2000
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