Rajiv Kumar Rai

Associate Partner

Bengaluru, Karnataka, India21 yrs 6 mos experience
Most Likely To SwitchHighly Stable

Key Highlights

  • 20+ years in clinical data management and medical coding.
  • Expert in MedDRA and WHODrug coding governance.
  • Proven track record in leading global clinical programs.
Stackforce AI infers this person is a Clinical Data Management expert with extensive experience in the pharmaceutical and CRO industries.

Contact

Skills

Other Skills

Internal ResourcingOracle ClinicalEDCICH-GCPGCPClinical TrialsData ManagementCROPharmacovigilanceCTMSCDISCClinical ResearchInformPharmaceutical Industry21 CFR Part 11

About

Senior Clinical Data Management & Medical Coding Leader with 20+ years of global pharmaceutical and CRO experience, delivering inspection-ready clinical data operations at scale across complex, multi-region portfolios. I specialize in building and leading high-performing global teams, governing MedDRA and WHODrug coding, and driving right-first-time delivery across the clinical trial lifecycle—from study start-up to database lock and regulatory submission. My career spans Big Pharma and CRO environments, where precision, compliance, and speed directly impact patient safety and business outcomes. I am recognized for combining deep technical authority with a strong commercial and operational mindset. I have led large coding and data management programs, overseen bi-annual dictionary up-versioning across hundreds of studies, implemented risk-based medical coding (RBMC), and served as a trusted escalation and governance leader for sponsors, audits, and inspections. My leadership style is grounded in accountability, transparency, and continuous improvement. I partner closely with sponsors, clinical teams, technology platforms, and senior stakeholders to simplify complexity, strengthen quality, and scale operations sustainably—without compromising regulatory rigor. I am passionate about roles where I can shape strategy, build resilient organizations, and deliver measurable impact across clinical development programs.

Experience

21 yrs 6 mos
Total Experience
4 yrs 5 mos
Average Tenure
10 yrs 9 mos
Current Experience

Fortrea

Associate Director, Medical Coding- Data Management at Fortrea

Jul 2023Present · 2 yrs 11 mos · India

Labcorp drug development

Associate Director, Data Management

Oct 2020Present · 5 yrs 8 mos · Bengaluru, Karnataka, India

Chiltern

Senior Manager, Data Management

Nov 2016Present · 9 yrs 7 mos · Bangalore

Chiltern international ltd.,

Manager, Medical Coding and Dictionary Specialist

Sep 2015Present · 10 yrs 9 mos · Bangalore, India

Theorem clinical research pvt. ltd.

Manager-Medical Coding and Dictionary Specialist

Aug 2014Aug 2015 · 1 yr · Bangalore

Accenture india services private limited

2 roles

Associate Manager at Accenture Services Pvt. Ltd.

Promoted

Jan 2012Jul 2014 · 2 yrs 6 mos

  • Associate Manager at Accenture services India Pvt. Ltd.

Team lead

Jul 2009Dec 2012 · 3 yrs 5 mos

Quintiles technologies india (pvt) ltd.

Clinical Data coordinator

Jan 2007Jun 2009 · 2 yrs 5 mos

  • Clinical Data Coordinator:
  • Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
  • Perform comprehensive quality control procedures for coding specifications.
  • Coding of Clinical Data using the dictionaries MedDRA and WHODD.
  • Performance of data management tasks including discrepancy review, query generation and updating, quality control procedures for studies.
  • Preparation of Data Management Documents mainly Data Coding Guidelines and SAE Reconciliation Guidelines.
  • Performing SAE Reconciliation
  • Manage delivery of projects through full data management study life-cycle
  • Defined the process for clinical coding, internal coding review, validation of coding tool and preparation of Data Coding Guidelines.
  • Implemented the process of metrics measurement for various coding activities like coding productivity, DE error metrics, Quality metrics.

Thaiba pharma

Product Specialist

Aug 2005Dec 2006 · 1 yr 4 mos

Lotus laboratories, bangalore

Clinical Pharmacist

Jan 2004Jan 2005 · 1 yr

Education

IIP

MBA in hospital management with HR

Jan 2007Jan 2009

Govt. College of Pharmacy, Bangalore

Bachelor of Pharmacy

Jan 1998Jan 2003

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