Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Information
Timeline
Generic
Pratiksha Sharma

Pratiksha Sharma

Associate Project Manager
Bengaluru

Summary

Results-driven Clinical Research Professional with over 8 years of progressive experience in clinical operations, project coordination, and stakeholder management. Currently an Associate Project Manager, leading cross-functional teams and ensuring successful execution of clinical trials across multiple phases. Adept at managing timelines, budgets, and regulatory compliance while maintaining high standards of quality and patient safety. Well-versed in Cardiology, Nephrology, Vaccine, Infectious, Oncology, endocrinology trials. Skilled at quickly learning new procedures. Offers advanced planning, problem-solving, and communication skills honed through years of clinical research success. Ready to bring expertise in project logistics and handling patient and investigator selection duties to a challenging new role. Eager to contribute to team success through hard work, attention to detail, and excellent organizational skills with a clear understanding of clinical trials and expertise in training peers. Motivated to learn, grow, and excel in an organization that values interpersonal skills, time management, and problem-solving abilities.

Overview

11
11
years of professional experience
13
13
years of post-secondary education
2
2
Languages

Work History

Associate Project Manager

Novo Nordisk India Pvt Ltd
10.2023 - Current
  • Monitored progress of projects through regular status updates, identifying potential issues and taking corrective actions when necessary.
  • Lead and manage end-to-end clinical trial operations for global studies across multiple therapeutic areas.
  • Collaborate with cross-functional teams including data management, PV, Vendor Management and regulatory affairs.
  • Monitor project timelines, budgets, and deliverables to ensure alignment with client expectations.
  • Identify and mitigate project risks, ensuring proactive issue resolution.
  • Conducted risk assessments to mitigate potential obstacles in the project lifecycle, ensuring smooth transitions between phases.
  • Supported senior project managers in executing complex initiatives by performing research, data analysis, and presentation preparation tasks as needed.
  • Evaluated team members'' performance throughout the duration of projects, providing constructive feedback for professional growth opportunities.
  • Participated in continuous improvement efforts within the organization by contributing ideas for process enhancements based on lessons learned from previous projects.
  • Served as the primary point of contact for clients during the entire course of assigned projects, addressing concerns and providing updates on progress.
  • Coordinated cross-functional teams to successfully achieve project milestones and objectives.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Analyzed project performance data to identify areas of improvement.
  • Monitored project progress, identified risks and took corrective action as needed.
  • Partnered with project team members to identify and quickly address problems.
  • Planned, monitored and analyzed project costs to meet financial goals.

Senior Clinical Research Associate

Novo Nordisk India Pvt Ltd
03.2023 - 10.2023
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Ensured compliance with protocol, ICH-GCP, and applicable regulatory requirements.
  • Mentored junior CRAs and supported training initiatives.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
  • Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
  • Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Prepared and maintained regulatory documents for clinical trial submissions.

Short Term Assignment-Associate Project Manager

Novo Nordisk India Pvt Ltd
02.2023 - 10.2023
  • Supported senior managers and department leaders by completing projects and problem resolution under tight budgets and schedule demands.
  • Delivered high level of service to clients to both maintain and extend relationship for future business opportunities.
  • Partnered with project team members to identify and quickly address problems.
  • Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets.
  • Devised and implemented attainable schedules, timelines and milestones for on-track projects.
  • Led team meetings to assess project progress and plan appropriately to meet delivery targets.
  • Mentored and guided staff to enhance performance and exceed customer expectations.
  • Negotiated contracts and agreements with vendors for constructive supplier relations.
  • Documented project progress to fulfill project requirements and establish traceability.
  • Developed and maintained project documentation for reliable records.
  • Generated weekly and monthly status reports for helpful progress tracking.
  • Recruited and oversaw personnel to achieve performance and quality targets.

Clinical Research Associate

Novo Nordisk India Pvt Ltd
04.2021 - 03.2023


  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Performed 80+ Monitoring Visit and traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
  • Followed drug storage procedures to comply with protocols and SOP requirements. Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
  • Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.



Clinical Research Associate-Consultant

Clinical Development Services Agency-ICMR
01.2020 - 03.2021
  • Experienced in conducting Site feasibility visit, Pre-Initiation Site visit, Site Initiation visit and site interim visit and site close out visit.
  • Complete 80+ Monitoring Visit.
  • Working for ongoing ICMR-ITRC TB Vaccine Trial at National Tuberculosis Institute, Bangalore as regional CRA
  • Verify data from CRFs to eCRF, monitor the participants schedules, file and collate trial documentation and reports; achieve study documentation and correspondence
  • Skilled in the preparation of follow up letters and Monitoring visit letters
  • Proactively involved in the training activities for the study site staff
  • Submission of the SAE documents to DCGI within the stipulated timelines
  • Involved in timely monitoring of Site Master File
  • Monitoring of essential documents pack
  • Support site for the translation of ICFs in the regional languages and for the IEC submission
  • Prepared the dossier for the IEC submission for the site initiation
  • Closely working with sites for the query and action items resolution and closure
  • Closely follow-up with the site for the timely submission of the documents to IEC as per the sponsor SOPs or IEC SOPs like site progress report, site annual renewal letters, reported protocol deviation/violation, amendment in the protocols, ICF or other study relevant documents
  • Experienced in monitoring the Drug accountability log, Site Training log, GCP Training certificates, CVs, MRCs and Site Delegation log and other site relevant documents

Clinical Research Associate-II

iProcess Clinical Research Organisation Pvt. Ltd
09.2018 - 01.2020
  • Experienced in monitoring multiple site locations, clinical site evaluation, initiation, maintenance and closeout visits in accordance with GCP and company SOPs while ensuring the integrity of study data and following study timelines
  • Conducted more than 150+ Site monitoring visits
  • Actively involved for the site feasibility for the RSV Vaccine project for US, UK and European sites
  • Verify data on CRFs, monitor schedules, file and collate trial documentation and reports; achieve study documentation and correspondence; preparing final reports
  • Skilled in the preparation of follow up letters and Monitoring visit letters
  • Involved in the site training activities; project refresher training, enrolment booster training, data entry training, EDC training and good source documentation practice training
  • Skilled in monitoring for the Site Investigator File which involves the essential documents pack and other site relevant documents
  • Closely follow-up with the site for the timely submission of the documents to IEC as per the sponsor SOPs or IEC SOPs like site progress report, site annual renewal letters, reported protocol deviation/violation, amendment in the protocols, ICF or other study relevant documents and also the notification of the PI changes etc
  • Submission of the SAE documents to DCGI within the stipulated timelines
  • Experienced in monitoring the Drug accountability and drug destruction log
  • Yearly twice reporting all the regulatory study status with DCGI
  • Manage regulatory authority applications and approvals
  • Handled site related payments activities
  • Proactively contributed for the oncology project for the site interim and closeout monitoring
  • Worked on DCGI Queries for SAE reporting with collaboration support from the site for the compensation and free medical management of the patients.

Clinical Process Associate

IQVIA
05.2017 - 08.2018
  • Providing different systems access used for the ongoing clinical trial for the site staff/ internal members
  • Worked on EDC systems like- RAVE/ INFORM
  • SME in Access Management in Inform and CTMS
  • Provide the team with the clinical reports necessary for different purposes-ISP/ other clinical trials related work
  • Worked on Investigators Payments Analysis for the trials and Cascading SUSAR letters to the sites (Investigator Alert Letters)
  • Liaise with CRA to prompt collection of documents and findings from EDC and file review
  • Study Newsletter preparation and cascading the newsletter to sponsor, site and CRO team members in a monthly basis
  • Maintaining FDA 1572 and FDF tracker at site level, QC and updating Site Delegation Log
  • Primary contact for IVRS start-up, updates, ensures site compliance, regular maintenance
  • Study specific E training design upload/assign and compliance check
  • SDV reconciliation and e CRF missing pages review
  • Ensuring all revised and updated essential documents are reviewed, tracked, and forwarded to the sponsor and filed in ELVIS and sponsor folders
  • Documents uploading and eTMF file review Core/Country/Site
  • I-Site pack preparation, Remote monitoring activities
  • Preparing meeting minutes for investigator, sponsor and internal CPM/CRA meetings
  • Country Recruitment Plans upload and FU with CRA
  • Maintaining FDA 1572 and FDF tracker at site level, QC and updating Site Delegation Log
  • Maintaining clinical trackers
  • Virtual ISF folder creation in ELVIS (TMF tool)
  • Subject Level Data Review, EDC Missing pages review and QC of essential documents
  • Conduct remote investigations on site performance issues and notify the clinical team
  • Perform ongoing Remote Data Review, assess for completeness of data and any observed protocol or GCP deviations or violations
  • Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other departments
  • Collaboration with project lead and team members in creation and review of study documents
  • Assist Project Leads with the creation of study document and plans (e.g Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g Training tracker, FAQ, etc.)



Intership

SM Pharmaceuticals Pvt. Ltd
09.2014 - 10.2014
  • A one-month vocational training in production field was done from S.M. PHARMACEUTICALS Pvt. Ltd. Complete report was submitted and achieved a certificate from S.M. Pharmaceuticals Pvt. Ltd.
  • Worked in the Quality Assurance and Quality Control Department in the Production Industry during the training.
  • In-hand experience for the Production, Packaging and Labeling of the Medication.

Education

Ph.D. - Clinical Research

DIT University- Research Centre-St. Johns College
Dehradun-Bengaluru
08.2020 - Current

Master of Pharmacy - Pharmacology And Toxicology

Rajiv Gandhi University of Health & Sciences
Bengaluru
05.2015 - 07.2017

B. Pharmacy - Pharmacy

Rajiv Gandhi University Of Health & Science
Bengaluru
07.2011 - 05.2015

SSC - Biology

Kendriya Vidyalaya, AFS
Kalaikunda, WB
03.2010 - 06.2011

HSC - 10th

Kendriya Vidyalaya, AFS
Kalaikunda, WB
03.2008 - 06.2009

Skills

    Educational activities

Project monitoring

Employee training

Trial study center set up

Coordinating site operations

Patient recruitment

Project Management

Accomplishments

Attended seminar and workshop

  • NMR Spectroscopy.
  • Basic techniques in pre-clinical studies
  • Drug development and challenges in drug developments (Clinical Trials).
  • Emerging trends in plant sciences in the development of drug.
  • National Workshop on regulatory compliances for accelerating innovation by CDSA.
  • Participated in DCGI meeting regarding upgrade in regulation of SAE.
  • Undergone multiple training by CDSA on GCP and Good source documentation practice

· Attended sessions for advanced Excel, CTMS, EDC & eTMF


Project

  • Evaluation of Nephroprotective Activity OF Citrus lanatus under Dr. V. Swamy in Pharmacology department of East Point College of Pharmacy, 2016- 2017. Bangalore-49.
  • Tuberculosis and its Outcome in patients with Diabetes Mellitus-Tuberculosis Comorbidity in Bangalore, South India, 2022-2023.


Publication:

  • Review Paper:- A Review on the Role of Pharmacogenomics And Pharmacotherapy For the Treatment of Tuberculosis To Optimize Patient Care Strategies. Journal of Positive Psychology, 2022, Vol 6, No 8, 4688-4693. Publication Impact Score-4+

Additional Information

  • Received Appreciation from the sponsor NYU and Mount Sinai for the hard work and smooth and successfully completing the closeout of the projects
  • Certificate in General course in Intellectual Property by WIPO
  • Achieved ranks in National Olympiads of Science, UN
  • Proactively taken part as a core coordinator in different programs in college fest & school and even core member of fun committee for CMS dept. in IQVIA
  • Involved as Core committee member for RaceFor7 marathon which serves for the race diseases
  • Got certification in various dance competition.
  • Have an Audit Experience in Novo Nordisk India.
  • Received BEST PROJECT AWARD for the project leading in Country.
  • Awarded as Best CRA and also Best Colleague award at Novo Nordisk.
  • Received the STAR CRA award in 2022 at Novo Nordisk
  • Appreciated by the different Stakeholders for the different activities i am involved with them regarding the support and team coordination.
  • Recognized with 2 “BRAVO” and “Applause” award for the good work in DSMB meeting and team coordination from IQVIA and other appreciation for the team building activities and high compliance work deliverable.
  • Involved as SME Position in all the Organization.
  • Currently proactively handling COSMOS (CTMS)-SME at Novo Nordisk.
  • Involved in the Committee Member in the Off-Site Event -2021 and also organized the study Local Investigator Meeting at Novo Nordisk.


Timeline

Associate Project Manager

Novo Nordisk India Pvt Ltd
10.2023 - Current

Senior Clinical Research Associate

Novo Nordisk India Pvt Ltd
03.2023 - 10.2023

Short Term Assignment-Associate Project Manager

Novo Nordisk India Pvt Ltd
02.2023 - 10.2023

Clinical Research Associate

Novo Nordisk India Pvt Ltd
04.2021 - 03.2023

Ph.D. - Clinical Research

DIT University- Research Centre-St. Johns College
08.2020 - Current

Clinical Research Associate-Consultant

Clinical Development Services Agency-ICMR
01.2020 - 03.2021

Clinical Research Associate-II

iProcess Clinical Research Organisation Pvt. Ltd
09.2018 - 01.2020

Clinical Process Associate

IQVIA
05.2017 - 08.2018

Master of Pharmacy - Pharmacology And Toxicology

Rajiv Gandhi University of Health & Sciences
05.2015 - 07.2017

Intership

SM Pharmaceuticals Pvt. Ltd
09.2014 - 10.2014

B. Pharmacy - Pharmacy

Rajiv Gandhi University Of Health & Science
07.2011 - 05.2015

SSC - Biology

Kendriya Vidyalaya, AFS
03.2010 - 06.2011

HSC - 10th

Kendriya Vidyalaya, AFS
03.2008 - 06.2009
Pratiksha SharmaAssociate Project Manager