Implementation Project Manager, eClinical & Pharmacovigilance

Cloudbyz; Bengaluru; Hybrid; INR 3,000,000 - 4,200,000; Full time

Job summary

Cloudbyz seeks an Implementation Project Manager to lead end-to-end eClinical and Pharmacovigilance deployments across multi-module platforms. You will coordinate across US and India teams, manage scope, timelines, budgets, and validation, and ensure regulatory alignment with GxP standards.

You will drive CTMS/eTMF/EDC deployments, data migrations, and integrations, delivering value and expanding opportunities while maintaining high customer satisfaction.

Qualifications

• 6+ years of project management experience in eClinical or PV systems.
• Hands-on delivery of 3+ full lifecycle implementations in GxP environments.
• Experience with clinical operations workflows from startup to submission.
• Experience delivering CSV/CSA validation deliverables and audits.
• Proven ability to manage budgets, changes, and multiple projects.

Responsibilities

• Lead implementations of CTMS, eTMF, EDC, CTFM, and Safety/PV modules using Cloudbyzs delivery methodology.
• Build and maintain project plans, RAID logs, resource plans, and status reporting; run steering committees.
• Manage scope, change requests, budgets, and margins on fixed-fee and TM engagements.
• Coordinate solution architects, Salesforce developers, analysts, and QA across US and India teams.
• Drive UAT, training, cutover, go-live, and hypercare, then hand over to Customer Success.

Skills

Project management

Stakeholder communication

GxP knowledge

Clinical operations

Data migration

Education

Life sciences degree

Tools

CTMS

eTMF

EDC

Veeva Vault

Job description

Job Details

• Title: Implementation Project Manager, eClinical Pharmacovigilance
• Location: Warrenville, IL (hybrid) or Bengaluru, India; remote considered for exceptional candidates
• Type: Full-time
• Travel: Up to 20% to customer sites

Role overview

You will own end-to-end delivery of Cloudbyz eClinical and Pharmacovigilance implementations, from kickoff to go-live and hypercare. You are the customers primary point of contact, keeping scope, timeline, budget, and validation on track across clinical operations, safety, IT, and quality stakeholders.

You will typically run 3-5 concurrent projects ranging from single-module CTMS or safety deployments to multi-module platform rollouts with data migration and integrations. Your work directly shapes customer time-to-value, referenceability, and expansion revenue.

Responsibilities

Project leadership and delivery

• Lead implementations of CTMS, eTMF, EDC, CTFM, and Safety/PV modules using Cloudbyzs delivery methodology.
• Build and maintain project plans, RAID logs, resource plans, and status reporting; run steering committees with customer executives.
• Manage scope, change requests, budget burn, and margin on fixed-fee and TM engagements.
• Coordinate solution architects, Salesforce developers, business analysts, and QA across US and India teams.

Requirements and solution design

• Facilitate discovery and fit-gap workshops with clinical operations, safety, regulatory, and finance users.
• Translate business processes (study start-up, site management, TMF filing, case intake through submission) into configuration requirements.
• Oversee data migration from legacy systems and integrations with EDC, IRT, ERP, safety databases, and regulatory gateways.

Validation and compliance

• Drive computer system validation (CSV/CSA) deliverables: validation plan, URS, FRS, IQ/OQ/PQ, traceability matrix, and summary report.
• Ensure delivery aligns with GxP, 21 CFR Part 11, EU Annex 11, ICH E6(R3), and GVP requirements.
• For PV projects, align configuration with E2B(R3) reporting, MedDRA/WHODrug coding, and expedited reporting timelines to FDA, EMA, and other authorities.

Customer success and growth

• Lead UAT, training, cutover, go-live, and hypercare, then hand over cleanly to Customer Success.
• Identify expansion opportunities (additional modules, AI agents, studies) and partner with Account Executives.
• Capture lessons learned and contribute templates and accelerators to the delivery playbook.

Required qualifications

• 6+ years of project management experience, including 4+ years implementing eClinical or safety/PV systems (eg, CTMS, eTMF, EDC, Argus, ArisG, Veeva Vault Clinical or Safety).
• Hands‑on delivery of at least three full‑lifecycle implementations in a GxP‑regulated environment.
• Working knowledge of clinical trial operations and/or pharmacovigilance workflows, from study start‑up to close‑out or case intake to regulatory submission.
• Experience producing CSV/CSA validation deliverables and supporting customer audits.
• Proven ability to manage budgets, change orders, and multiple concurrent projects with distributed teams.
• Strong executive communication and workshop facilitation skills.
• Bachelors degree in life sciences, pharmacy, engineering, computer science, or a related field.

Preferred qualifications

• Salesforce platform experience; Salesforce Administrator, Consultant, or Health Cloud certification.
• PMP, PRINCE2, or PMI-ACP certification; comfort with hybrid Agile/Waterfall delivery.
• Prior experience at a CRO, pharma/biotech sponsor, or eClinical vendor.
• Background in safety database migrations, E2B gateway setup, or signal management.
• Exposure to AI‑enabled workflows in clinical or safety operations.
• Experience working across US and India delivery models.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.