This document contains the resume of Nidhi Rai. It summarizes her educational background including an M.Sc. in Clinical Research from ICRI Bangalore and B.Sc. in Biotechnology. Her work experience includes over 5 years of experience as a Clinical Research Associate and Centralized Monitoring Lead at Quintiles Pvt Ltd, Karmic Lifesciences LLP, CliniRx Pvt Ltd, and Panacea Biotech Pvt Ltd. Her therapeutic areas of experience include psychiatry, endocrinology, vaccines, and cardiovascular disease. She has experience in monitoring visits, source data verification, query resolution, regulatory submissions, and study management.

1. Nidhi Rai
C 211, Ganga Ocean Park, Katraj Pune.
India
+ 91 7776840337
Email- nidhi.rai094@gmail.com
Career Objective:
To continuemy career with an organization thatwill utilizemy management, supervision and administrativeskills
to benefit mutual growth and success.
Educational Qualification:
• M.Sc. (Clinical Research) (2007-2009) fromICRI Bangalore,(Cranfield University UK)
• B.Sc. (Biotechnology) (2004-2007) from Jiwaji University,Gwalior
Employment History
Quintiles Pvt Ltd.
Date of Employment: 01/2015 - Present
Job Title: Centralized MonitoringLead (Global)
Key Responsibilities:
 Leading team of total 15 CRA, Clinical Analystand Clinical AnalystSupport.
 Managing the execution of the assigned medium to largemulti regionally-based clinical study(ies) per
Contract, from initiation through to closeout. Also ensuring that all clinical study management and project
deliverables arecompleted to the Sponsor’s satisfaction,ensuringquality deliverables on time and within
budget and in accordancewith SOPs,policies and practices.
 Managing the study startup in collaboration with PMand Regulatory Lead.
 PreparingMonitoringPlan.
 Modifyingvisitreports accordingstudy specificrequirements
 Oversightof CTMS updates.
 Coaches/mentors CRA team.
 Develops project-specific trainingmaterialsfor team.
 Assists and supports web based trainingmaterial preparation.Assists when needed in the preparation of
company and scientific/medical presentations to potential clients and atInvestigators’meetings
 Lead in department merging (Centralized clinical operation). Exchanging knowledge, presentation, giving
trainings to other department.
 Develop study management plans,together with team assignments and accountabilities and oversightof
databasemaintenance.
 Protocol deviation documentation, trackingand escalation.
 Report reviewing.
 Develop patient recruitment and retention plans.
 Lead problem solvingand resolution efforts to includemanagement of risk,contingencies and issues.
Develop proactivecontingency plans to mitigate clinical risk.

2.  Identify quality issues within thestudy through regular review of sitecommunications,monitoringvisit
reports, data flow information and quality assuranceauditfindings to implement appropriatecorrective
action plans.Escalatefindings and action plansto appropriateparties .
 Provideinput to linemanagers of their project team members’ performance relativeto project tasks.
Recommend team members’ further professional development. Support staff development.
Karmic Lifesciences LLP (Sep 2014-Dec 2014)
 Clinical Research Associate II
Key Responsibilities:
• Site qualification activities.
• Facilitation of EC submissions.
• Preparingpre-study documentation
• Site Initiation activities
• Drug & material accountability
• CaseReport Form development
• Clinical TrialsSupplies Management
• Tracking& review of completed CRFs
• Monitoringactivities
• Adverse event & serious adverseevent reporting.
• Site Closureactivities
• GCP compliance
• Query Resolution
CliniRx Pvt Ltd. (Oct 2012-May 2013)
 Clinical Research Associate II
Key Responsibilities:
• Site qualification activities.
• Facilitation of EC submissions.
• Preparingpre-study documentation
• Site Initiation activities
• Drug & material accountability
• CaseReport Form development
• Clinical TrialsSupplies Management
• Tracking& review of completed CRFs
• Monitoringactivities
• Adverse event & serious adverseevent reporting.
• Site Closureactivities
• GCP compliance
• Query Resolution

3. Panacea Biotech Pvt Ltd (Feb 2011-April 2012)
 Clinical Research Associate
Key Responsibilities:
Same as above
St.John's Research Institute (Oct 2009-Feb 2011)
 Research Assistant
Key Responsibilities:
Same as above
Therapeutic Area:
 Psychiatry (Schizophrenia,MDD, Bipolar disorder)
 Endocrinology (Diabetes Mellitus Type 2)
 Vaccines (Pneumococcal,OPV)
 Cardiovascular Disease(Hypertension, Coronary artery disease)
Department Specific Experience
Department: Clinical
Category Experience
OC-RDC, 1-2
EDC-Other Inform, Rave 1-2
On-Site MonitoringExperience: ≥5 Years Yes
Audits and/or Regulatory Inspection Yes
ClosureVisits Yes
Collection and Review of Regulatory Packages Yes
Conducting CRA Training Yes
Conducting GCP Training Yes
Drug Accountability Yes
Feasibilities Yes

4. Category Experience
ICF/Study Document Development Yes
Initiation Visits Yes
Investigator Meeting Attendance Yes
Management of SAEs Yes
MonitoringVisits & Source Data Verification Yes
Query Resolution Yes
Reg Body and/or Ethics Comm Submissions Yes
Re-labelingand/or IP Recall Process Yes
Site Selection Visits Yes
Study Files Maintenance Yes
Language(s)
Language Speaking Reading Writing
English Fluent Fluent Fluent
Hindi Fluent Fluent Fluent
References:
1. Dr. Manish Harsh:AssociateDirector Clinical GDN; Quintiles Research PvtLtd 09986013862
2. Mr. Sudip Sinha:Functional Head Novartis Hyderabad 09100989996
3. Dr. Alben Sigamani:Head Narayana Health:9886646986
4. Mr. Ajith Madanan:Clinical ProjectManager,Karmic Lifesciences +91-9619313202