Curriculum Vitae

Mr.Swapnil Balasaheb Todmal

Flat No 45,B Wing ,3 Floor,Gulmohar Society,Khadaki Aundh Road, Bopodi
rd

Pune-411020
Email: swapniltodmal8@gmail.com

Tel: - +91-9730324230

Objective: An opportunity to work in a vibrant and exciting environment that hones

my skills and to contribute positively towards the growth and prosperity of
the company and also to secure a position in this ever-expanding field by
virtue of my sincerity and dedication.

Educational Qualification:-

Name of Exam. Year of Passing Board/University Percentage (%)

Final year B 67.83%
2006 Pune University
Pham.
H.S.C. 2002 Pune Divisional Board 69.00%

S.S.C. 2000 Pune Divisional Board 65.46%

Certifications:

 Certificate Course in Clinical Research from ‘Jehangir Centre for Learning’.

Work experience: -

1. Currently working for TransPerfect Life Science Pvt. Ltd as Senior Clinical Document
Lead, since 01 Mar 2020.
2. Worked for TransPerfect Life Science Pvt. Ltd as Clinical Document Lead, since 01
Mar 2018 to 28 Feb 2020.
3. Worked for TransPerfect Life Science Pvt. Ltd as Clinical Document Specialist III,
since Aug 2015 to 28 Feb 2018.
4. Worked for TransPerfect Life Science Pvt. Ltd as Clinical Trial Specialist since 15
JUL 2013 to 30 Jul 2015.
5. Worked for Jehangir Clinical Development Centre (J.C.D.C.) as Clinical Team Leader,
since 02 MAY 2012 to 12 JUL 2013.
6. Worked for Jehangir Clinical Development Centre (J.C.D.C.) as Clinical Research
Coordinator, since 10th MAY 2010 to 1 May 2012.
7. Worked for National AIDS Research Institute (N.A.R.I.) as Research Pharmacist,
since 2 Nov 2007 to 08 MAY10
ETMF Domain Experienced- Trail Interactive, Veeva Vault, Roche ETMF

I) Responsibility at TransPerfect Life Science as a Clinical Document Lead /

Senior
Clinical Document Lead (eTMF Management):-

 Performing Managerial Activity which includes assessment of Quality, Appraisals

assessment, conducting trainings, team coordination for positive environment
 Participate in the selection of New Team member
 Participate in the onboarding process for New Team member
 Assignments of Trainings, Tracking of Trainings status, Assessments
 Assignment of Project to team members
 Currently Study eTMF lead of 6 Clients with more than 20 studies.
 Review of TMF Completeness Report ,Missing Placeholder
 As a study lead primarily responsible for creation of TMF Processing plan, Action
Decision and Communication log per client and attending KOMs.
 Attending client meeting on weekly basis.
 Review of study email correspondence and mark them as relevant/non relevant in order
to file in eTMF.
 Collaboration & sharing data with client about review
 Uploading, Indexing and review of documents in eTMF as per DIA reference Model.
 As lead responsible for creating missing place folder.
 Coordination with coding team in order to ensure filing of documents as per DIA model
and Configuration Manual
 Attending Client Meetings, escalating coding related issues with possible solutions for
final client decision.
 Performing Internal Audits to maintain eTMF Quality
 Analysis of Study room (Room build QC )as per client approval before start indexing in
any new study
 Manages Q&As for assigned projects
 Coordinate with PMs for requirements of updates in system configurations or mapping
documents
 Assist the PMs in client meetings or provide them with required data on assigned projects
as needed by the clients
 Assist Senior TMF Quality Specialist in performing internal audits when needed
 Review audit plans before finalizing with the client and ensure the internal audits are
performed as per the audit plan
 Perform random QC checks on assigned projects to ensure eTMF quality
 Come up with valuable suggestions for improving the processes and performances of
fellow team members
 Be able to take up mentorship role for fellow team members as required
 Coordinate with team members across the globe and ensure that all the team’s function in
a similar way to ensure consistency across a project Respond to client requests for new
project initiatives. Collaborate with various members of the production and sales teams to
assess the scope of work and produce cost estimates.
 Take a proactive role in learning about clients’ industry, business needs and company
culture, educating the project team, identifying new business opportunities and providing
a high level of service.
 Set and fulfill client expectations.
 Perform other special projects or duties when required.
II) Responsibility at TransPerfect Life Science as a Clinical Document Specialist
III (eTMF Management) :

 Study Lead responsibility of 8 Clients with more than 20 studies.

 Responsible for QC2 and review of study documentation for Trial Master File
(TMF) quality for sponsor and/or CRO studies
 Perform study lead responsibilities, be responsible for the assigned studies, and
ensure that the project runs smoothly from start to end
 Keep project mappings up-to-date, coordinate with Project Managers (PMs) to
ensure required changes are made both in the mapping document and in Trial
Interactive (TI)
 Communicate with PMs and the team to ensure the project timelines are met and a
good quality TMF is maintained
 Participate in trainings for new team members and re-training activities
 Attending Client Meetings, escalating coding related issues with possible solutions
for final client decision.
 Performing Internal Audits to maintain eTMF Quality
 Analysis of Study room (Room build QC )as per client approval before start
indexing in any new study
 Manages Q&As for assigned projects
 Coordinate with PMs for requirements of updates in system configurations or
mapping documents
 Assist the PMs in client meetings or provide them with required data on assigned
projects as needed by the clients
 Assist Senior TMF Quality Specialist in performing internal audits when needed
 Review audit plans before finalizing with the client and ensure the internal audits are
performed as per the audit plan
 Perform random QC checks on assigned projects to ensure eTMF quality
 Come up with valuable suggestions for improving the processes and performances of
fellow team members
 Respond to client requests for new project initiatives; collaborate with various
members of the Production and Sales teams to assess the scope of work and produce
cost estimates
 Take a proactive role in learning about clients’ industry, business needs and
company culture, educating the Project Team, identifying new business
opportunities, and providing a high level of service
 Set and fulfill client expectations
 Perform other special projects or duties when require

III) Responsibility at TransPerfect Life Science as a Clinical Trial Specialist (eTMF

Management) :-
  Responsible for QC and review of study documentation for e-Trial Master File (e-
TMF) quality for sponsor and/or CRO studies.
 Coding of documentation in Trial Interactive (English, Non- English document).
 Periodic audits of client TMFs when contracted as well as internal TMF audits.
 Participate and become an expert in the TMF Reference Model and stay current on
regulatory changes.
 Become an expert in Trial Interactive features, functionality, and work with Life
Sciences Solutions, Project Management and Development to recommend new
features and functionality to improve the product and reduce manual activities.
 Take a proactive role in learning about clients’ industry, business needs and
company culture, educating the project team, identifying new business
Opportunities and providing a high level of service.
 Set and fulfill client expectations.
 Perform other special projects or duties when required.
 Attending project meetings/ international teleconferences with clients
 Motivating the team to achieve high standards and uniformity in work to fulfill the
client’s requirements.
 Guiding the team members regarding document query.
 To train new team member on the process

IV) Trials Experience at Jehangir Clinical Development Centre (J.C.D.C.):-

Total number of Trials handled 12

Sr.No. Indication Phase

1 Advanced Stage Non-small Cell Lung Cancer III
2 Stage IIIB/IV or recurrent non small cell lung cancer III
3 Von Will Brand III
4 Early-Stage Breast Cancer III
5 Metastatic Soft-Tissue or Bone Sarcomas. III
6 Advanced Refractory Malignancies I
7 Hemophilia A IV
8 Ovarian Cancer (Unblinded Team) III
9 Hemophillia B III
10 Diabetes II and Nephorpathy II
11 Chronic Lymphocytic Leukemia III
12 Epithelial Ovarian,Primary Peritoneal or Fallopian III
Tube Cancers

Responsibility At Jehangir Clinical Development Centre As a Team Leader

Total Team Member-12

 Developing SOPs and Work Instruction for the various processes involved in Clinical
Research and Site.
 Supervising all the documentation related to clinical research.
 Coordination of QA- QC of all Documentations including SMF, Source Document,SAE
Form
 Attending project meetings/ international teleconferences with sponsors and Protocol
specialists and training sessions.
 Suggesting, initiation, recommendation and/or providing solutions as appropriate
 Guiding the team members and motivating them to stay focused.
 Motivating the team to achieve high standards
 Dealing with and resolving problems and issues which arise
 Arranging & chairing weekly team meetings, focusing on targets & achievements
 Implementing new initiatives.

Responsibility At Jehangir Clinical Development Centre As a CRC

.
 Assisting PI in patient recruitment.
 ICF process and Source documentation.
 Updating of SMF
 IP Management - Study drug accountability.
 Screening and Enrollment of study subjects and Patient care.
 eCRF and paper CRF completion.
 Interactive Voice Respond System (IVRS) calling.
 Sample labeling and dispatching.
 SAE & AE monitoring, reporting and follow up of study.
 IEC/IRB correspondence including SAE submission, all essential documents.
 Managing all trial activities including site initiation, sponsor visit, auditor visit etc.

Successfully faced following Sponsor Audit without any Major and Minor Finding at JCDC

Sr.No. Indication Phase Year of Audit

1 Hemophillia A III MAR 2011
2 Advanced Refractory I FEB 2011
Malignancies
3 Ovarian Cancer III MAR 2012
(Unblinded Team)

Successfully faced following US FDA Audit without any Major and Minor Finding at JCDC

Sr.No. Indication Phase Year of Audit

1 Hemophillia B III SEP 2012

IV) Trials Experience at National AIDS Research Institute (N.A.R.I.):-

Sr.No. Indication Phase

1. HIV 1 in Serodiscordant couples III
2. HIV 1 IV

Responsibilities in NARI
 Developing SOPs for the various processes involved in Clinical Research.
 Supervising all the documentation related to clinical research.
 Coordination of QA- QC of all Documentations.
 Handling site-monitoring audits.
 Telephonic coordination with sites, sub-sites and site monitors
 Attending project meetings/ international teleconferences with sponsors and Protocol
specialists and training sessions.
 Identifying and recording quality problems and monitoring-related issues across sites.
 Suggesting, initiation, recommendation and/or providing solutions as appropriate.
 Perform other study related tasks as assigned by Head, Clinical Trial Operations, and
Principal Investigators.

My Strengths

1. Optimistic attitude.
2. Good interpersonal skills.
3. Can get the work done from others.
4. Can work with team or take initiative.
5. Can work under pressure.
6. Good understanding of Clinical Research associated processes and procedures.
7. Practical and methodical approach in completing tasks.
8. Well-organized and detail-oriented.
9. Always seeking to learn and grow.
10. Multitasking

Computer Skills:
Tools: Computer Basics (MS Word, Power Point, Excel)

Industrial Training
Successfully completed one month in plant training at LIBRA DRUG, Mangalwar Pet, and Pune.

Project Done During the Course of B. Pharmacy

1) Paper Presentation at Symposium 2006 arranged at
Chopada on Memory Enhancing Herbal Drug
‘BRAHMI’
2) Experimental Project on Extraction of Starch from
‘Amaranth Seed’ in 2004

Personal Information
Date of Birth : 8th Jan 1984
Sex : Male.
Languages Known : English, Hindi and Marathi
Hobbies : Reading, Swimming, Traveling, Cooking

References of Current Organization: -

1) Nikita Ratnaparkhi
Associate Director, Transperfect Life Sciences Solutions
Cell +91 9922992968, +1(747) 2824839

2) Lipsa Panigrahi
Clinical Document Team Manager, Transperfect Life Sciences Solutions
Cell +91 7875205388

Place:
Date: / / (Swapnil B.Todmal)