LIMS & Share point
Siddhesh Chavan
Lab Project Set up Manager
Mumbai,MH
Summary
Efficient, dynamic & result oriented professional with 18+ years of experience and a proven knowledge of case management, customer service and data collection & analysis. Seeking to contribute expertise in Power BI development and data analysis to a forward-thinking organization. Proficient in leveraging advanced analytics tools to transform raw data into actionable insights. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
18
18
years of professional experience
3
3
Certification
3
3
Language
3
3
years of post-secondary education
Work History
Lab Project Set-Up Manager
Q Square Lab Solution, IQVIA
Mumbai, MH
06.2021 - 10.2022
- Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization.
- Develop the database design requirements which include configuration definition for full protocols, protocol amendments and Sponsor study changes, developing and maintaining client design standards as applicable in accordance with the Clinical Protocol.
- Collaborate with other teams and communicate & coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.
- Collaborated with cross-functional teams to gather requirements and understand business needs.
- Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
- Lead in the development of sponsor specific standards and program- specific set-up procedures
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice
- Training and mentoring new hires.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Worked effectively in fast-paced environments.
- Proven ability to learn quickly and adapt to new situations.
- Skilled at working independently and collaboratively in a team environment.
Project Manager
Metropolis Healthcare Ltd
Mumbai, MH
04.2016 - 06.2021
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Functioned as key point of contact to client & focused on timely and successful completion of full lifecycles of assigned projects.
- Conferred with customers each day to maintain current understanding of needs and preferences, resolve issues, and promote brand loyalty.
- Introduced new methods, practices, and systems to reduce turnaround time
- Implemented process improvement to shape organizational culture, optimize procedures for higher efficiency and help company evolve and grow
- Researched emerging products and used researched information to update store's inventory
- Monitoring and reviewing of Data Transfer Set up and live subject data file
- Conducted data validation and quality assurance to ensure accuracy and reliability of analytical findings
- Analyzed large datasets to extract actionable insights and uncover trends using Excel and other analytical tools
- Initiate project set up activity, close monitoring of study execution and closed out activity.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Query resolution/escalation and closing of RCA & appropriate CAPA
- Monitored team members to enhance professional development and accountability in workplace.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
Team Lead
Metropolis Healthcare Ltd
Mumbai, MH
11.2010 - 03.2016
- Preparation study specific documents and get it approved by sponsor
- Close monitoring on tracking of clinical research samples
- Reviewing of investigation reports
- Maintain the track of deviation observed during the period of study tenure
- Query resolution/management
- Setting-up & preparation live subject Data Transfer File Conducted training and mentored team members to promote productivity and commitment to friendly service
- Served as a role model for the team by demonstrating commitment to excellence, professionalism, and adherence to company values at all times.
- Promoted a positive work environment by fostering teamwork, open communication, and employee recognition initiatives.
- Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
- Trained new team members by relaying information on company procedures and safety requirements.
Sr, Clinical Research Associate
Bombay Bioresearch Centre
Mumbai, MH
11.2007 - 03.2010
- Prepared/Reviewed the study related document like study protocol, ICF and CRF
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Counseling to study participant prior to screening and participate in the study
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion adherence with study protocol and applicable regulatory authority.
- Managed project risk by identifying, quantifying and monitoring potential threats.
Asst. Supervisor
Borosil Glass Work Ltd
Mumbai, MH
05.2004 - 09.2007
- Arranged and maintained of raw materials required for each machine, packing materials
- Worked out the ‘Machine Production Performance Reports' maintain it for audit
- Prepared and maintained the record of ‘Dispatched Clearance Reports'
- Certified the laboratory glass wares as per its quality and quantity and generate th certificate for each product having A grade.
- Worked closely with other supervisors to create a cohesive, high-performing team that consistently met or exceeded company objectives.
- Maintained clean and well-organized production areas to avoid violations or unnecessary work delays due to hazards or inefficient layouts.
- Coordinated with day shift supervisor to balance staffing as workloads changed.
- Ensured compliance with company policies and industry regulations by diligently monitoring operations and addressing issues proactively.
- Maintained safety records and accident reports for human resources.
- Maintained accurate inventory, working with purchasing department and logistics for resupply.
Education
Bachelor of Science - Chemistry
Mumbai University
06.2001 - 03.2004
Higher Secondary School Certificate - Science
Maharashtra Board
06.1999 - 02.2001
Skills
- Project Management, Team Management, Managing people, Communication, Process
- Quick learner, passionate to work with dedication, strong problem-solving skills
- Strong experience in excel (pivots, VLOOKUP’s, formulas, and charts)
- Excellent communication and collaboration ability
- SAS Base programming
- Currently pursing Data Science with SQL programming, Python, AI & ML
- Power BI includes DAX formulas and enterprise workspaces
- SAS Programming- SAS Base-SAS Advanced
- Key Performance Indicators (KPI)
- Timelines and Milestones
Certification
- PG MBA in Service Excellence conducted by Welingkar Institute of Management Studies, Mumbai, Maharashtra, India.
- PG Diploma in Clinical Research & Trails Management, conducted by Institute of Clinical Research India, Mumbai, Maharashtra, India.
- Executive PG Certification in Data Science & Artificial Intelligence conducted by iHUB DivyaSampark at Indian Institute of Technology Roorkee in Association with Department of Science & Technology.
- The Simplest Gide of SAS Programming - SAS Base-SAS Advanced conducted by UDEMY.
Timeline
Lab Project Set-Up Manager
Q Square Lab Solution, IQVIA
06.2021 - 10.2022
Project Manager
Metropolis Healthcare Ltd
04.2016 - 06.2021
Team Lead
Metropolis Healthcare Ltd
11.2010 - 03.2016
Sr, Clinical Research Associate
Bombay Bioresearch Centre
11.2007 - 03.2010
Asst. Supervisor
Borosil Glass Work Ltd
05.2004 - 09.2007
Bachelor of Science - Chemistry
Mumbai University
06.2001 - 03.2004
Higher Secondary School Certificate - Science
Maharashtra Board
06.1999 - 02.2001
Work Preference
Work Type
Full TimeWork Location
RemoteHybridOn-SiteImportant To Me
Company CultureWork-life balanceCareer advancementHealthcare benefitsPersonal development programsPaid sick leaveFlexible work hoursTeam Building / Company RetreatsPaid time offWork from home optionAccomplishments
- Collaborated with team of 10 in the development of clinical research projects.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Software
Outlook
MS team
SQL Base
SAS Base
Python, ML and Data Science
Power BI
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