Portfolio Company Positions

About OpenClinica:

OpenClinica makes clinical trials more efficient and effective with advanced technology and recruitment solutions. Our industry-leading EHR-to-EDC connectivity automates source data acquisition, reduces errors, and eliminates delays, while our precision recruitment solutions help teams enroll the right participants with ease. Trusted by the world's leading life sciences companies, academic institutions, and government agencies, OpenClinica bridges the gap between healthcare and research.

About the Role and Team:

The Technical Project Manager (TPM) is responsible for planning, executing, and delivering complex clinical trial technology implementations for life sciences customers. This role sits within the Professional Services organization and serves as the primary point of coordination across customers, internal delivery teams, and third-party vendors.

The TPM oversees implementations of clinical trial software solutions including EDC, Randomization, Data Analytics, ePRO/eCOA, EHR-to-EDC integrations, and Patient Recruitment platforms, ensuring projects are delivered on time, within scope, and in compliance with regulatory and quality standards.

• Location: Fully Remote in the U.S.
• Status: Full-time, Exempt
• Reports to: Vice President of Professional Services

What You Will Do:

• Project Delivery & Execution

  • Lead end-to-end delivery of customer implementation projects from kickoff through go-live and handoff to support

  • Develop and manage detailed project plans, timelines, milestones, dependencies, and resource allocations

  • Ensure projects are delivered in alignment with contractual scope, quality standards, and customer expectations

  • Act as an escalation path for internal teams in relation to a customer’s project challenges or issues.

• Technical & Functional Coordination

  • Act as the primary coordination point between customers, solution consultants, training, engineering teams, customer success managers (CSM’s), sales, compliance, information technology (IT) and customer support (CS).

  • Understand system architecture, integrations, and data flows across EDC, Randomization, ePRO/eCOA, data analytics, EHR integrations, and recruitment platforms

  • Translate customer requirements into clear technical and functional deliverables

• Customer & Stakeholder Management

  • Serve as the primary customer-facing project contact

  • Lead project governance meetings, status reviews, and steering committee updates

  • Proactively manage risks, issues, and change requests, providing clear communication and mitigation plans

• Quality, Compliance & Documentation

  • Ensure project delivery aligns with GxP, 21 CFR Part 11, and internal quality management systems and policies.

  • Oversee creation and approval of project documentation including project plans, requirements, validation deliverables, and Unite site documentation (EHR to EDC integration solution)

  • Support audit readiness by maintaining accurate and complete project records

• Financial & Commercial Management

  • Track project budgets, forecasts, and burn rates

  • Manage scope changes and support change order development in partnership with account and services leadership

  • Ensure accurate project reporting, billing readiness, and revenue recognition.

• Cross-Functional Collaboration

  • Partner with Sales, Customer Success, Product, Engineering, and Support to ensure smooth customer onboarding and lifecycle transitions

  • Contribute to continuous improvement of Professional Services methodologies, templates, and best practices

Qualifications:

Required:

• 5+ years of project management experience delivering enterprise software or technical implementations
• Experience working in Professional Services or customer-facing delivery organizations
• Strong understanding of clinical trial operations and clinical data workflows
• Experience managing complex, multi-workstream projects with external customers

• Prolonged periods sitting at a desk and working on a computer.

• Must be able to lift up to 15 pounds at times.

• Travel may be required on occasion (< 5%)

Nice to Have:

• Hands-on experience with clinical trial systems such as EDC, Randomization, ePRO/eCOA, data analytics, CTMS, or patient recruitment platforms

• Experience with EHR-to-EDC or other healthcare system integrations

• Familiarity with regulated environments (GxP, 21 CFR Part 11)

• PMP, PRINCE2, Agile, or similar project management certification

• Experience working with SaaS platforms and cloud-based deployments

• Experience working with Monday.com

Key Competencies:

• Customer-focused delivery mindset

• Strong technical and systems-thinking orientation

• Risk and issue management

• Ability to translate complex technical concepts for non-technical audiences

• Attention to detail in regulated environments