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Job Description

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

About Cloudbyz

Cloudbyz builds the unified, Salesforce-native eClinical platform for life sciences. Our suite spans CTMS, eTMF, EDC, Clinical Trial Financial Management (CTFM), and Safety & Pharmacovigilance, extended by a portfolio of AI agents built on Salesforce Agentforce.

We serve pharma, biotech, CROs, SMOs, medical device, diagnostics, and cosmetics organizations. Headquartered in Warrenville, Illinois, with a delivery center in Bengaluru, India, we are a fast-growing challenger to legacy eClinical vendors, winning on one data model, faster deployment, and lower total cost.

The role

You will own end-to-end delivery of Cloudbyz eClinical and Pharmacovigilance implementations, from kickoff to go-live and hypercare. You are the customer's 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.

Key responsibilities

Project leadership and delivery

• Lead implementations of CTMS, eTMF, EDC, CTFM, and Safety/PV modules using Cloudbyz's 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 T&M 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 (e.g., 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.
• Bachelor's 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.

Why join Cloudbyz

• Shape delivery at a growth-stage company challenging the incumbents in eClinical.
• Work on a modern, unified platform with AI agents built into clinical and safety workflows.
• Direct visibility with leadership and a clear path to Senior PM or Delivery Lead roles.
• Competitive salary, performance bonus, health benefits, and professional certification support.

How to apply

Send your resume and a short note describing an eClinical or PV implementation you led, including its scope and outcome, to careers@cloudbyz.com.

Cloudbyz is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate on any basis protected by law.

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