Project Management Institute

Global Operations Center

14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Name for correspondence from PMI

Prefix First Name Middle Name
Vikas
Last Name Suffix
Kumar
Preferred Phone Number Preferred Email Address
1 3439884222 vkuma014@uottawa.ca

Contact Information (Home)

Address Line 1
402
Address Line 2
7 biggin court
City State/Province/Territory Zip/Postal Code
Nort York ON M4A 1M3
Country
Canada

Person: 5669618/Application: 4568730 Page 1 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Name as it should appear on Certificate

Name on Certificate
Vikas Kumar

Attained Education
Highest level of education attained Year degree was awarded PMI Accredited?
Masters 2009 No
Name of High School, College or University
Punjabi University
Address Line 1
Punjabi University Campus
Address Line 2
Rajpura Road
City State/Province/Territory Zip/Postal Code
Patiala
Country

Field of Study
Other

Person: 5669618/Application: 4568730 Page 2 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Project Management Experiences

Clinical study of glioblastoma multiforme drug (EMA): Overview

Date Started Date Through

Aug 2011 Apr 2013
Project Role Primary Industry
Project Contributor Other

Clinical study of glioblastoma multiforme drug (EMA): Organization Details

Job Title
Senior Research Scientist
Organization Name
Fresenius Kabi Oncology
Address Line 1
Plot No 11 Echleon, Institutional Area, Sector 32, Gurugram, Haryana 122018, India
City State/Province/Territory Zip/Postal Code
Gurgaon
Country
India
Phone Number
91 1244885000
Contact Name
Vaibhav Choudhary
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
vaibhav.choudhary@fresenius-kabi.com 91 1244885000

Clinical study of glioblastoma multiforme drug (EMA): Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
60.00 80.00 350.00 Monitoring the Project 80.00
200.00
Project Role
Project Contributor
Description
"Objective: Clinical study of glioblastoma multiforme drug (EMA)

Person: 5669618/Application: 4568730 Page 3 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Outcome:Clinical study report.

Role: Senior Research Scientist/Contributor.

Responsibilities/Deliverable: - Initiation: Reviewed quotes from CROs; attended bid defence meeting- Planning: Feasibility of project, defined scope and
timelines - Execution: Kept stakeholders engaged, QC of project documents- Monitoring/Control: Weekly status reports, tracked resolution of changes
- Close-out: Entry into internal database; closing contracts"

Clinical study of glioblastoma multiforme drug (Brazil): Overview

Date Started Date Through

Aug 2011 Apr 2013
Project Role Primary Industry
Project Contributor Other

Clinical study of glioblastoma multiforme drug (Brazil): Organization Details

Job Title
Senior Research Scientist
Organization Name
Fresenius Kabi Oncology
Address Line 1
Plot No 11 Echleon, Institutional Area, Sector 32, Gurugram, Haryana 122018, India
City State/Province/Territory Zip/Postal Code
Gurgaon
Country
India
Phone Number
91 1244885000
Contact Name
Vaibhav Choudhary
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
vaibhav.choudhary@fresenius-kabi.com 91 1244885000

Clinical study of glioblastoma multiforme drug (Brazil): Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
60.00 80.00 350.00 Monitoring the Project 80.00
200.00

Person: 5669618/Application: 4568730 Page 4 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Project Role
Project Contributor
Description
"Objective: Clinical study of glioblastoma multiforme drug (Brazil)

Outcome:Clinical study report.

Role: Senior Research Scientist/Contributor.

Responsibilities/Deliverable: - Initiation: Reviewed quotes from CROs; attended bid defence meeting- Planning: Feasibility of project, defined scope and
timelines - Execution: Kept stakeholders engaged, QC of project documents- Monitoring/Control: Weekly status reports, tracked resolution of changes
- Close-out: Entry into internal database; closing contracts"

Pilot Clinical Study of estrogen receptor antagonist in Healthy Subjects: Overview

Date Started Date Through

Sep 2014 Feb 2016
Project Role Primary Industry
Project Contributor Other

Pilot Clinical Study of estrogen receptor antagonist in Healthy Subjects: Organization Details

Job Title
Senior Research Scientist
Organization Name
Fresenius Kabi Oncology
Address Line 1
Plot No 11 Echleon, Institutional Area, Sector 32, Gurugram, Haryana 122018, India
City State/Province/Territory Zip/Postal Code
Gurgaon
Country
India
Phone Number
91 1244885000
Contact Name
Vaibhav Choudhary
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
vaibhav.choudhary@fresenius-kabi.com 91 1244885000

Person: 5669618/Application: 4568730 Page 5 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Pilot Clinical Study of estrogen receptor antagonist in Healthy Subjects: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
70.00 140.00 380.00 Monitoring the Project 40.00
150.00
Project Role
Project Contributor
Description
Objective: Pilot Clinical Study of estrogen receptor antagonist in Healthy Subjects

Outcome:Clinical study report.

Role: Senior Research Scientist/Contributor.

Responsibilities/Deliverable: - Initiation: Reviewed quotes from CROs; attended bid defence meeting- Planning: Feasibility of project, defined scope and
timelines - Execution: Kept stakeholders engaged, QC of project documents- Monitoring/Control: Weekly status reports, tracked resolution of changes
- Close-out: Entry into internal database; closing contracts

Monitoring visits for a clinical study with Anti-diabetic drug: Overview

Date Started Date Through

Jan 2018 Apr 2018
Project Role Primary Industry
Other: Auditor/Monitor Other

Monitoring visits for a clinical study with Anti-diabetic drug: Organization Details

Job Title
QA Associate/CRA
Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5
City State/Province/Territory Zip/Postal Code
Montreal PQ
Country
Canada
Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre

Person: 5669618/Application: 4568730 Page 6 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626

Monitoring visits for a clinical study with Anti-diabetic drug: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
10.00 20.00 50.00 Monitoring the Project 6.00
12.00
Project Role
Other: Auditor/Monitor
Description
Objective: Monitoring visits for a clinical study with Anti-diabetic drug

Outcome : Monitoring report.

Role: Auditor/Monitor.

Responsibilities/Deliverable: - Initiation: Review of similar completed projects- Planning: Writing audit plan/agenda; feasibility of project - Execution:
On-site audit conduct - Monitoring/Control: Follow up on the observations with client until complete resolution- Close-out: Deliverable to sponsor,
archiving

GAP Analysis for standard operating procedures (SOPs) of a Pharma Company: Overview

Date Started Date Through

Feb 2018 Feb 2018
Project Role Primary Industry
Consultant Other

GAP Analysis for standard operating procedures (SOPs) of a Pharma Company: Organization Details

Job Title
MedQualis Inc.
Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5
City State/Province/Territory Zip/Postal Code
Montreal PQ
Country
Canada

Person: 5669618/Application: 4568730 Page 7 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626
GAP Analysis for standard operating procedures (SOPs) of a Pharma Company: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
10.00 25.00 40.00 Monitoring the Project 6.00
8.00
Project Role
Consultant
Description
Objective: GAP Analysis for SOPs of a Pharmaceutical Company vs. Industry requirements to provide recommendations to client

Outcome:GAP analysis report.

Role: Consultant.

Responsibilities/Deliverable: - Initiation: Quote preparation and initial documents review - Planning: Feasibility of project - Execution: Visiting client
site, and reviewed their processes - Monitoring/Control:Follow up on the observations with client until complete resolution- Close-out: Deliverable to
sponsor, archiving

Monitoring of Estradiol clinical study under Fasting Conditions: Overview

Date Started Date Through

Mar 2018 Apr 2018
Project Role Primary Industry
Other: Auditor/Monitor Other

Monitoring of Estradiol clinical study under Fasting Conditions: Organization Details

Job Title
QA Associate/CRA
Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5

Person: 5669618/Application: 4568730 Page 8 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

City State/Province/Territory Zip/Postal Code

Montreal PQ
Country
Canada
Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626
Monitoring of Estradiol clinical study under Fasting Conditions: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
6.00 18.00 50.00 Monitoring the Project 8.00
8.00
Project Role
Other: Auditor/Monitor
Description
"Objective: Monitoring of Estradiol clinical study under Fasting Conditions

Outcome : Monitoring report.

Role: Auditor/Monitor.

Responsibilities/Deliverable: - Initiation: Review of similar completed projects- Planning: Writing audit plan/agenda; feasibility of project - Execution:
On-site audit conduct - Monitoring/Control: Follow up on the observations with client until complete resolution- Close-out: Deliverable to sponsor,
archiving"

Monitoring of Omeprazole clinical study under Fasting Conditions 0209-18: Overview

Date Started Date Through

Apr 2018 Apr 2018
Project Role Primary Industry
Other: Auditor/Monitor Other

Monitoring of Omeprazole clinical study under Fasting Conditions 0209-18: Organization Details

Job Title
QA Associate/CRA

Person: 5669618/Application: 4568730 Page 9 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5
City State/Province/Territory Zip/Postal Code
Montreal PQ
Country
Canada
Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626
Monitoring of Omeprazole clinical study under Fasting Conditions 0209-18: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
8.00 28.00 60.00 Monitoring the Project 8.00
12.00
Project Role
Other: Auditor/Monitor
Description
"Objective: Monitoring of Omeprazole clinical study under Fasting Conditions 0209-18

Outcome : Monitoring report.

Role: Auditor/Monitor.

Responsibilities/Deliverable: - Initiation: Review of similar completed projects- Planning: Writing audit plan/agenda; feasibility of project - Execution:
On-site audit conduct - Monitoring/Control: Follow up on the observations with client until complete resolution- Close-out: Deliverable to sponsor,
archiving"

Auditing of a CRO for Qualification purpose and auditing of three studies : Overview

Date Started Date Through

May 2018 May 2018
Project Role Primary Industry
Other: Auditor/Monitor Other

Person: 5669618/Application: 4568730 Page 10 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Auditing of a CRO for Qualification purpose and auditing of three studies : Organization Details

Job Title
QA Associate/CRA
Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5
City State/Province/Territory Zip/Postal Code
Montreal PQ
Country
Canada
Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626

Auditing of a CRO for Qualification purpose and auditing of three studies : Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
4.00 16.00 30.00 Monitoring the Project 6.00
8.00
Project Role
Other: Auditor/Monitor
Description
"Objective: Auditing of a Contract Research Organisation (CRO) for Qualification purpose as well as auditing of three clinical studies data (Project with
defined scope of multiple tasks)

Outcome : Audit report.

Role: Auditor/Monitor.

Responsibilities/Deliverable: - Initiation: Review of similar completed projects- Planning: Writing audit plan/agenda; feasibility of project - Execution:
On-site audit conduct - Monitoring/Control: Follow up on the observations with client until complete resolution- Close-out: Deliverable to sponsor,
archiving"

Clinical Study of Alectinib under fasting conditions.: Overview

Person: 5669618/Application: 4568730 Page 11 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Date Started Date Through

May 2018 Mar 2019
Project Role Primary Industry
Project Manager Other

Clinical Study of Alectinib under fasting conditions.: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Clinical Study of Alectinib under fasting conditions.: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
30.00 40.00 60.00 Monitoring the Project 30.00
100.00
Project Role
Project Manager
Description
Objective: Clinical Study of Alectinib under fasting conditions.

Outcome:Clinical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting-

Person: 5669618/Application: 4568730 Page 12 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Planning: Assisted team in slotting the project; feasibility of project - Execution: hosting audits, directing team about timelines - Monitoring/Control:
Weekly status reports, tracked resolution of changes - Close-out: Deliverable to sponsor, archiving

Clinical Study of Alectinib under fed conditions: Overview

Date Started Date Through

May 2018 Mar 2019
Project Role Primary Industry
Project Manager Other

Clinical Study of Alectinib under fed conditions: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Clinical Study of Alectinib under fed conditions: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
30.00 40.00 60.00 Monitoring the Project 30.00
100.00
Project Role
Project Manager
Description
Objective: Clinical Study of Alectinib under fed conditions.

Person: 5669618/Application: 4568730 Page 13 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Outcome:Clinical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting- Planning: Assisted
team in slotting the project; feasibility of project - Execution: hosting audits, directing team about timelines - Monitoring/Control: Weekly status
reports, tracked resolution of changes - Close-out: Deliverable to sponsor, archiving

Bio-analytical Analysis for plasma samples from Crisaborole Clinical Study: Overview
Date Started Date Through
Aug 2018 Dec 2018
Project Role Primary Industry
Project Manager Other

Bio-analytical Analysis for plasma samples from Crisaborole Clinical Study: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Bio-analytical Analysis for plasma samples from Crisaborole Clinical Study: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
15.00 15.00 20.00 Monitoring the Project 20.00
50.00

Person: 5669618/Application: 4568730 Page 14 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Project Role
Project Manager
Description
Objective: Conduct Analysis for plasma samples from Criasborole clinical studyOutcome: Bioanalytical study report

Role: Project Manager

Responsibilities/Deliverable: - Initiation: Quotes for approval of sponsor/internal members- Planning: Feasibility- Execution: Directing team about
timelines - Monitoring/Control: Weekly status , tracked resolution of changes - Closeout: Deliverable to sponsor

Clinical Study of Pomalidomide Prodrug under fasting conditions.: Overview

Date Started Date Through

Aug 2018 Mar 2019
Project Role Primary Industry
Project Manager Other

Clinical Study of Pomalidomide Prodrug under fasting conditions.: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Clinical Study of Pomalidomide Prodrug under fasting conditions.: Project Details

Initiating the Project

Person: 5669618/Application: 4568730 Page 15 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

30.00 Planning the Project Executing the Project Controlling and Closing the Project
30.00 0.00 Monitoring the Project 0.00
0.00
Project Role
Project Manager
Description
"Objective: Conduct bio-equivalence study of Pomalidomide

Outcome: Project is still ongoing, final outcome would be clinical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting- Planning: Assisted
team in slotting the project; feasibility of project - Execution: execution not yet started - Monitoring/Control: execution not yet started- Close-out:
Project ongoing"

Bio-analytical Analysis for plasma samples from Sumatriptan Clinical Study: Overview

Date Started Date Through

Sep 2018 Apr 2019
Project Role Primary Industry
Project Manager Other

Bio-analytical Analysis for plasma samples from Sumatriptan Clinical Study: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director

Person: 5669618/Application: 4568730 Page 16 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Contact E-mail Contact Phone Number

Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Bio-analytical Analysis for plasma samples from Sumatriptan Clinical Study: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
15.00 15.00 20.00 Monitoring the Project 10.00
30.00
Project Role
Project Manager
Description
Objective: Conduct Analysis for plasma samples from Sumatriptan Clinical studyOutcome: Bioanalytical study report

Role: Project Manager

Responsibilities/Deliverable: - Initiation: Quotes for approval of sponsor/internal members- Planning: Feasibility- Execution: Directing team about
timelines - Monitoring/Control: Weekly status , tracked resolution of changes - Closeout: Deliverable to sponsor

Monitoring of Omeprazole clinical study under Fed Conditions: Overview

Date Started Date Through

Nov 2018 Dec 2018
Project Role Primary Industry
Other: Auditor/Monitor Other

Monitoring of Omeprazole clinical study under Fed Conditions: Organization Details

Job Title
QA Associate/CRA
Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5
City State/Province/Territory Zip/Postal Code
Montreal PQ
Country
Canada
Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre

Person: 5669618/Application: 4568730 Page 17 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626

Monitoring of Omeprazole clinical study under Fed Conditions: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
8.00 28.00 60.00 Monitoring the Project 8.00
12.00
Project Role
Other: Auditor/Monitor
Description
"Objective: Monitoring of Omeprazole clinical study under Fasting Conditions 0103-17

Outcome : Monitoring report.

Role: Auditor/Monitor.

Responsibilities/Deliverable: - Initiation: Review of similar completed projects- Planning: Writing audit plan/agenda; feasibility of project - Execution:
On-site audit conduct - Monitoring/Control: Follow up on the observations with client until complete resolution- Close-out: Deliverable to sponsor,
archiving"

Monitoring of Omeprazole clinical study under Fasting Conditions 0102-17: Overview

Date Started Date Through

Nov 2018 Dec 2018
Project Role Primary Industry
Other: Auditor/Monitor Other

Monitoring of Omeprazole clinical study under Fasting Conditions 0102-17: Organization Details

Job Title
QA Associate/CRA
Organization Name
MedQualis Inc.
Address Line 1
1240 Beaumont Ave, Montreal, QC H3N 1W5
City State/Province/Territory Zip/Postal Code
Montreal PQ
Country
Canada

Person: 5669618/Application: 4568730 Page 18 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Phone Number
1 5145260626
Contact Name
Brigitte Marcheterre
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
bmarcheterre@medqualis.com 1 5145260626
Monitoring of Omeprazole clinical study under Fasting Conditions 0102-17: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
8.00 28.00 60.00 Monitoring the Project 8.00
12.00
Project Role
Other: Auditor/Monitor
Description
"Objective: Monitoring of Omeprazole clinical study under Fasting Conditions 0102-17

Outcome : Monitoring report.

Role: Auditor/Monitor.

Responsibilities/Deliverable: - Initiation: Review of similar completed projects- Planning: Writing audit plan/agenda; feasibility of project - Execution:
On-site audit conduct - Monitoring/Control: Follow up on the observations with client until complete resolution- Close-out: Deliverable to sponsor,
archiving"

Clinical study of Medroxyprogesterone under fasting conditions : Overview

Date Started Date Through

Nov 2018 Mar 2019
Project Role Primary Industry
Project Manager Other

Clinical study of Medroxyprogesterone under fasting conditions : Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road

Person: 5669618/Application: 4568730 Page 19 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

City State/Province/Territory Zip/Postal Code

Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@Lambdacanada-cro.com 1 4167523636 x371
Clinical study of Medroxyprogesterone under fasting conditions : Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
30.00 30.00 50.00 Monitoring the Project 0.00
110.00
Project Role
Project Manager
Description
Objective: Conduct bio-equivalence study of Medroxyprogesterone

Outcome: The project is still ongoing, the outcome of project would be clinical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting- Planning: Assisted
team in slotting the project; feasibility of project - Execution: hosting audits, directing team about timelines - Monitoring/Control: Weekly status
reports, tracked resolution of changes - Close-out: Project ongoing

Clinical study of Methylprednisolone (Multi dose vial) under fasting conditions : Overview

Date Started Date Through

Nov 2018 Mar 2019
Project Role Primary Industry
Project Manager Other

Clinical study of Methylprednisolone (Multi dose vial) under fasting conditions : Organization Details

Job Title
Project Manager

Person: 5669618/Application: 4568730 Page 20 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371
Clinical study of Methylprednisolone (Multi dose vial) under fasting conditions : Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
30.00 30.00 50.00 Monitoring the Project 0.00
110.00
Project Role
Project Manager
Description
Objective: Conduct bio-equivalence study of Methylprednisolone (Multi-dose)

Outcome: Project is still ongoing, final outcome would be clinical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting- Planning: Assisted
team in slotting the project; feasibility of project - Execution: hosting audits, directing team about timelines - Monitoring/Control: Weekly status
reports, tracked resolution of changes - Close-out: Project ongoing

Bio-analytical Analysis for plasma samples from Enrofloxacin Pre-clinical study: Overview

Date Started Date Through

Nov 2018 Mar 2019
Project Role Primary Industry
Project Manager Other

Person: 5669618/Application: 4568730 Page 21 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Bio-analytical Analysis for plasma samples from Enrofloxacin Pre-clinical study: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Bio-analytical Analysis for plasma samples from Enrofloxacin Pre-clinical study: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
15.00 25.00 0.00 Monitoring the Project 0.00
0.00
Project Role
Project Manager
Description
Objective: Conduct Bio-analytical Analysis for plasma samples from Enrofloxacin Pre-clinical StudyOutcome: Project shelved after planning stage

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting- Planning: Assisted
team in slotting the project; feasibility of project - Execution: Project shelved after planning - Monitoring/Control: Project shelved after planning -
Close-out:Project shelved after planning

Bio-analytical Analysis For plasma samples from Ganaxolone Pre-clinical samples: Overview

Date Started

Person: 5669618/Application: 4568730 Page 22 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Feb 2019 Date Through

Mar 2019
Project Role Primary Industry
Project Manager Other

Bio-analytical Analysis For plasma samples from Ganaxolone Pre-clinical samples: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Bio-analytical Analysis For plasma samples from Ganaxolone Pre-clinical samples: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
15.00 15.00 0.00 Monitoring the Project 0.00
0.00
Project Role
Project Manager
Description
Objective: Conduct Bio-analytical Analysis for plasma samples from Ganaxolone Pre-clinical StudyOutcome: Project is still ongoing, final outcome
would be bioanalytical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting-

Person: 5669618/Application: 4568730 Page 23 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Planning: Assisted team in slotting the project; feasibility of project - Execution: execution not yet started - Monitoring/Control: execution not yet
started- Close-out: Project ongoing

Clinical study of Methylprednisolone (single dose vial) under fasting conditions: Overview

Date Started Date Through

Apr 2019 Apr 2019
Project Role Primary Industry
Project Manager Other

Clinical study of Methylprednisolone (single dose vial) under fasting conditions: Organization Details

Job Title
Project Manager
Organization Name
Lambda Therapeutic Research Inc.
Address Line 1
460 Comstock Road
City State/Province/Territory Zip/Postal Code
Toronto ON
Country
Canada
Phone Number
1 4167523636 x371
Contact Name
Dr. Netal Desai
Contact Relationship
Manager/Director
Contact E-mail Contact Phone Number
Netal.Desai@lambdacanada-cro.com 1 4167523636 x371

Clinical study of Methylprednisolone (single dose vial) under fasting conditions: Project Details

Initiating the Project Planning the Project Executing the Project Controlling and Closing the Project
30.00 30.00 50.00 Monitoring the Project 0.00
110.00
Project Role
Project Manager
Description
Objective: Conduct bio-equivalence study of Methylprednisolone (Single-dose)

Person: 5669618/Application: 4568730 Page 24 of 25 Generated: Apr 13, 2019 12:02 PM

 Project Management Institute
Global Operations Center
14 Campus Blvd., Newtown Square, PA 19073-3299 USA
Tel: +1 610-356-4600, Fax: +1 610-482-9971
E-mail: CustomerCare@pmi.org, Internet: www.pmi.org

Outcome: Project is still ongoing, final outcome would be clinical study report.

Role: Project Manager.

Responsibilities/Deliverable: - Initiation: Prepared quotes for approval of sponsor/internal members; attended bid defence meeting- Planning: Assisted
team in slotting the project; feasibility of project - Execution: hosting audits, directing team about timelines - Monitoring/Control: Weekly status
reports, tracked resolution of changes - Close-out: Project ongoing

Project Management Education

Project Management I: Education Course

Title
Project Management I
Institution
University of Ottawa
Date Started Date Ended Hours
Jan 2017 Feb 2017 18.00

Project Management II: Education Course

Title
Project Management II
Institution
University of Ottawa
Date Started Date Ended Hours
Mar 2017 Apr 2017 18.00

Person: 5669618/Application: 4568730 Page 25 of 25 Generated: Apr 13, 2019 12:02 PM