Ravinder Singh
Chandigarh
Summary
Dynamic Project Manager with extensive experience at AstraZeneca, excelling in clinical trial oversight and budget negotiation. Proven track record in stakeholder engagement and risk mitigation strategies, ensuring timely project delivery. Adept at cross-functional collaboration and training development, driving team performance and compliance with regulatory standards.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Local Study Associate Director/Manager
AstraZeneca Pharma India Limited
Bangalore
05.2021 - Current
- End to End project Management of Studies Allocated to AstraZeneca India
- Lead allocated Global Clinical Trials in India
- Oversaw and managed projects to ensure clinical trials were completed on schedule and within budget.
- Prepared country project budget, negotiated study budget with sites, and finalized clinical study agreements.
- Ensure studies are conducted in compliance with GCP, AZ SOP’s and regulatory requirements.
- Engaged KOLs for recruitment, ensured quality oversight, and improved data metrics for the project.
- Managed relationships with vendors to ensure timely delivery of clinical trial materials.
- Preparation of Regulatory submission of project, delivery of Project Presentation in SEC Meetings for project approvals
- Design and deliver training on the direct reports within the department.
Project Manager – Clinical Trial Management
Lambda Therapeutic Research Ltd.
Ahmedabad
11.2019 - 04.2021
- Lead Clinical Trials in Oncology (Global Trials)
- Oversaw and managed projects to ensure clinical trials were completed on time and within budget.
- Engaged cross-functional teams from project initiation through execution to ensure alignment with clinical study report (CSR) objectives.
- Responsible for leading cross functional team of clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Coordinated with international project teams to enhance collaboration and project alignment.
- Tracked and communicated project status regularly to keep all stakeholders informed and aligned.
- Ensure studies are conducted in compliance with GCP, LTR SOP’s and regulatory requirements.
Project Manager – Clinical Research
Meril Life Sciences Pvt. Ltd.
Vapi
07.2018 - 11.2019
- Management and co-ordination with cross-functional project teams to support milestone achievement and to manage study issues and obstacles.
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
- Lead project team to ensure quality, timelines and budget management.
- Accountable for the financial performance of each project.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Oversaw all project deliverables, ensuring alignment with study objectives and timelines.
- Maintained quality and completeness of TMF for assigned projects.
- Managed study components for inspection readiness across all aspects of study conduct.
- Oversight for development and implementation of project plans.
- Prepare project management reports for management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Acted as primary liaison between Company and vendors to facilitate timely study launch, conduct, and closeout per contractual agreements.
- Design and deliver training on the direct reports within the department.
- Conduct interview, selection and training of new joinees.
- Performance appraisal review of the direct reports.
- Engaged key opinion leaders to gather insights and feedback, informing project strategies and enhancing study relevance.
- (A Medical Device Company)
Project Manager – Monitoring
JSS Medical Research India Private Limited
Faridabad
06.2016 - 06.2018
- Coordinated cross-functional project teams to support milestone achievement and address study issues and obstacles.
- Developed comprehensive study management plans to ensure effective project execution.
- Acted as primary project contact person to Sponsor, maintaining and improving communication and adhering to reporting schedules.
- Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.
- Identified quality issues within the study through regular review of site communications, monitoring visit reports, data flow information, and quality assurance audits to implement corrective action plans and escalate findings to stakeholders.
- Performing co-monitoring/accompanied site visits and ongoing mentoring of CRA team to ensure high performance and efficiency of the clinical team.
- Prepared and delivered project presentations at SEC meetings at CDSCO.
- Participate in proposal development and bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
Sr. Clinical Research Associate
Syngene International Ltd.
Bangalore
09.2015 - 06.2016
Clinical Research Associate-II (Clinical Operations Project Manager onsite GSKCH)
inVentiv International Pharma Services Pvt. Ltd.
Gurgaon
01.2013 - 08.2015
Trainee Assistant Project Manager – Monitoring
Max Neeman International
New Delhi
12.2011 - 01.2013
Clinical Research Associate
Tech-observer India Pvt. Ltd.
New Delhi
08.2010 - 11.2011
Manager – Training Center
Klintelligen Healthcare India Pvt. Ltd.
New Delhi
10.2009 - 03.2010
Sr. Data Management Coordinator
Apothecaries Foundation
New Delhi
02.2009 - 09.2009
Assistant Team Lead/ Analyst
ADI Backoffice Professional Ltd. India offsite Informa (former Citeline Inc.)
Mohali
07.2005 - 01.2009
Education
Masters in Business Administration - Project Management
Sikkim Manipal University
Chandigarh, India01.2015
PG Diploma in Health, Family Welfare & Population Education - Health Management
Panjab University
Chandigarh, India01.2008
Bachelor of Homoeopathic Medicine & Surgery - Medicine
Panjab University
Chandigarh, India01.2005
Skills
- Clinical trial oversight
- Regulatory submission
- Budget negotiation
- Vendor management
- Stakeholder engagement
- Risk mitigation strategies
- Cross-functional collaboration
- Project management
- Data analysis
- TrialTrove
- Pubmed
- Clinicaltrialsgov
- Journals (JCO)
- Conferences (ASCO, EULAR, etc)
- Pharmaceutical databases
- Clinicaltrialresultsorg
- Microsoft Project Professional 2007 & 2010
- IMedidata
- Veva Clinical Vault
- ETrack 20
- Clinion
- Edc2go
- Octalsoft CTMS
- BizNet eDC
- Process improvement
- Performance appraisal
- Team leadership
- Training development
- Decision-making
- Negotiation
- Risk analysis
- Problem solving
- Effective communication
- Team building
- Compliance assurance
- Project methodology
- Budget management
Certification
Six Sigma Green Belt Certification, Indian Statistical Institute, New Delhi, Delhi.
Authentication
Ravinder Singh, 01/23/26
Languages
English, Listen, Speak, Read and Write
Audits And Inspections - Successful Audits
- Sponsor Audits, 7, Level 2 and Level 3 audits
- Quality Audits, 2, Green Audits
- EC Inspection, 2
- DCGI Inspection, 1
Summary Of Project Experience - Therapeutic Area Experience
mBC (4 GCT, Phase Ib/III & Phase III), BTC (2 GCT, Phase III), mCRC (1 study: Phase III), Gastric Cancer (1 study: Phase III), mCRPC (1 study: Phase IV), OC (1 study: Phase III, Patient PK study), Rotavirus (1 study: Phase III), Tdap (1 study: Phase II/III), Hexavalent (1 study: Phase I), T2DM (1 local trial, Phase III), Pre-diabetics (PK Study 1 study: PK), Transcatheter Aortic Valve Replacement (TAVR) (1 study: First-in Human), Peripheral Artery Disease (2 studies: First-in-Human), Coronary Artery Disease (3 studies in DES: 1 Registry and 2 Phase IV study), Vascular Closure Device (1 study, Post Marketing), Heart Failure (1 study: Phase III), Psoriasis (1 study: Phase III), Cognitive Function in Children (1 study), Cognitive Function in Children using CANTAB and fMRI (1 study), Total Knee Replacement (1 study: First-in-Human), Total Knee Joint Replacement (1 study: Post Marketing), Total Hip Replacement (1 study: Post Marketing), Acute Low Backache (1 study: Phase III), Joint Pain (2 study: Phase II and Phase III), Chronic OA (1 study: Phase IV, Thermal Imaging), Rheumatoid Arthritis (Phase III), Nutritional Supplement study in children (3 studies), Gingivitis (1 study: Global), Gum bleeding (1 study), Plaque calibration (1 study)
Timeline
Local Study Associate Director/Manager
AstraZeneca Pharma India Limited
05.2021 - Current
Project Manager – Clinical Trial Management
Lambda Therapeutic Research Ltd.
11.2019 - 04.2021
Project Manager – Clinical Research
Meril Life Sciences Pvt. Ltd.
07.2018 - 11.2019
Project Manager – Monitoring
JSS Medical Research India Private Limited
06.2016 - 06.2018
Sr. Clinical Research Associate
Syngene International Ltd.
09.2015 - 06.2016
Clinical Research Associate-II (Clinical Operations Project Manager onsite GSKCH)
inVentiv International Pharma Services Pvt. Ltd.
01.2013 - 08.2015
Trainee Assistant Project Manager – Monitoring
Max Neeman International
12.2011 - 01.2013
Clinical Research Associate
Tech-observer India Pvt. Ltd.
08.2010 - 11.2011
Manager – Training Center
Klintelligen Healthcare India Pvt. Ltd.
10.2009 - 03.2010
Sr. Data Management Coordinator
Apothecaries Foundation
02.2009 - 09.2009
Assistant Team Lead/ Analyst
ADI Backoffice Professional Ltd. India offsite Informa (former Citeline Inc.)
07.2005 - 01.2009
Masters in Business Administration - Project Management
Sikkim Manipal University
PG Diploma in Health, Family Welfare & Population Education - Health Management
Panjab University
Bachelor of Homoeopathic Medicine & Surgery - Medicine
Panjab University