SAS Programming- SAS Base-SAS Advanced – Import and export raw data files Import and export raw data files (eg text, excel, csv, etc) Manipulate and transform data Manipulate and transform data Create and combine SAS data sets and various reports & Graphs Use SAS statements and procedures, Proc SQL, etc SAS Macroanced
Siddhesh Chavan
Lab Project Manager-Clinical Trials & SAS Programmer
Mumbai
Summary
Efficient professional with 18+ years of experience and a proven knowledge of case management, customer service and data collection & analysis.
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
17
17
years of professional experience
2
2
Certifications
1
1
Language
Work History
Lab Project Set-Up Manager
Q Square Lab Solution, IQVIA
Mumbai
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 team from Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
- Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
- Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
- Participate in external and internal audits as required
- Provide day to day guidance to more junior staff assigned to project or within a specific program area; may act as a mentor as well as assist in the training and development of more junior staff
- Lead in the development of sponsor specific standards and program-specific set-up procedures
- Participate in improvement projects as defined by the relevant process improvement management team
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice
- Training and mentoring to new hires.
Deputy Manager
Metropolis Healthcare Ltd
Mumbai
04.2019 - 05.2021
- Introduced new methods, practices, and systems to reduce turnaround time.
- Supervised and motivated staff employees.
- Assumed senior management workloads in absence of general manager to maintain operations continuity.
- Researched emerging products and used researched information to update store's inventory.
- Functioned as point of contact for project administrators and managers focused on timely and successful completion of full lifecycles of assigned projects.
- Implemented process improvement to shape organizational culture, optimize procedures for higher efficiency and help company evolve and grow.
- Conferred with customers each day to maintain current understanding of needs and preferences, resolve issues, and promote brand loyalty.
- Participate in study kick off meeting and monitor set up activity
- Reviewing of study documents
- Monitoring and reviewing of Data Transfer Set up and live subject data file.
- Study close out activity.
Assistant Manager
Metropolis Healthcare Ltd
Mumbai
04.2016 - 03.2019
- Initiate project set up activity when study get awarded
- Participate in Investigator Meeting organized by sponsor
- Query resolution/escalation and preparation of RCA & appropriate CAPA
- Monitor and provide study update/progress
- Monitor and control over all study activity and timeline
- Reviewing live data transfer files.
- Made hiring recommendations to increase company's productivity and profitability with quality workers.
- Mentored 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.
- Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
Team Lead
Metropolis Healthcare Ltd
Mumbai
04.2013 - 03.2016
- Preparation of SOPs.
- Preparation of study specific document and get it approved by sponsor
- Addressing and logging complaint in the logger
- 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.
- Worked with team to identify areas of improvement and devised solutions based on findings.
Associate Team Lead
Metropolis Healthcare Ltd
Mumbai
11.2010 - 03.2013
- Preparation of SOP
- Preparation of study specific document and get it approved by sponsor
- Addressing and logging complaint in the logger
- Close monitoring on tracking of clinical research samples
- Reviewing of investigation reports
- Maintaining the track of deviation observed during the period of study tenure.
Sr. Exe. Clinical Research Associate
Bombay Bioresearch Centre
Mumbai
04.2009 - 03.2010
- Review the study related document like study protocol, ICF and CRF
- Monitor study recruitment process
- Counseling to study participant prior to screening and participate in the study
- Monitor the clinical trials processes and each activity and ensure to be conducted adherence with study protocol and applicable regulatory authority
- Review SOP prepared by CRA
- Reviewing source document records during and post clinical trial
- Ensure accuracy and correctness of data recorded in ICF, CRF and source document.
- Worked well in a team setting, providing support and guidance.
Exe. Clinical Research Associate
Bombay Bioresearch Centre
Mumbai
11.2007 - 04.2009
- Preparation of study related document like study protocol, ICF and CRF
- Participate in study recruitment process.
- Participate in counseling process and assist to Sr. CRA to complete the consent process
- Participate in the clinical trials processes and each activity and ensure to be conducted adherence with study protocol and applicable regulatory authority
- Preparation of SOP
- Recoding data in source document on real time basis
- Ensure accuracy and correctness of data recorded in ICF, CRF and source document.
Asst. Supervisor
Borosil Glass Work Ltd
Mumbai
04.2005 - 09.2007
- Arrangement of raw materials required for each machine, packing materials for finished product
- Workout the ‘Machine Production Performance Reports’ maintain the record for audit purpose
- Prepare and maintain the record for ‘Dispatched Clearance Reports’ on daily/monthly basis and make it available for audit purpose
- Make inventory of raw material, packaging material and finished product on monthly basis.
- Maintained clean and well-organized production areas to avoid violations or unnecessary work delays due to hazards or inefficient layouts.
- Worked with management team to implement proper division of responsibilities.
- Coordinated with day shift supervisor to balance staffing as workloads changed.
Technical Officer
Borosil Glass Work Ltd
Mumbai
05.2004 - 03.2005
- Checking quality and quantity of scientific glass wares used in laboratory
- Certify the laboratory glass wares as per its quality and quantity and generate th certificate for each product having A grade
- Maintain the record of each certificate for with respective technician's name and identity code.
Education
B. Sc. - Chemistry
Mumbai University
Mumbai, MH 06.2021 - 03.2004
Higher Secondary School Certificate -
Maharashtra Board
Kankavali, Maharashtra. 06.2000 - 06.2001
Secondary School Certificate -
S.N.M. Vidyalaya, Kharepatan
Kankavali, Maharashtra, India 06.1998 - 03.1999
Skills
Team Management / Managing People / Communication / Quick Learnerundefined
Certification
MBA in Service Excellence, Welingkar Institute of Management Studies- Mar 2017
Software
References
- Ms. Sayli Rane:
Metropolis Healthcare Ltd
General Manager
sayli.rane@metropolisindia.com
98190 62814
- Ms. Mugdha Hule:
Metropolis Healthcare Ltd
Project Manager
mugdha.h@metropolisindia.com
9967007628
Timeline
B. Sc. - Chemistry
Mumbai University
06.2021 - 03.2004
Lab Project Set-Up Manager
Q Square Lab Solution, IQVIA
06.2021 - 10.2022
Deputy Manager
Metropolis Healthcare Ltd
04.2019 - 05.2021
Assistant Manager
Metropolis Healthcare Ltd
04.2016 - 03.2019
Team Lead
Metropolis Healthcare Ltd
04.2013 - 03.2016
Associate Team Lead
Metropolis Healthcare Ltd
11.2010 - 03.2013
Sr. Exe. Clinical Research Associate
Bombay Bioresearch Centre
04.2009 - 03.2010
Exe. Clinical Research Associate
Bombay Bioresearch Centre
11.2007 - 04.2009
Asst. Supervisor
Borosil Glass Work Ltd
04.2005 - 09.2007
Technical Officer
Borosil Glass Work Ltd
05.2004 - 03.2005
Higher Secondary School Certificate -
Maharashtra Board
06.2000 - 06.2001
Secondary School Certificate -
S.N.M. Vidyalaya, Kharepatan
06.1998 - 03.1999
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