Consultant, Clinical Systems Integration, Study Repatriation

Eliassen Group; United States; Remote; USD 105,000 - 140,000; Full time

Job summary

A leading company is seeking a Consultant for Clinical Systems Integration to lead a crucial project focused on repatriating a clinical oncology program. This role involves managing cross-functional teams and ensuring that all integration activities are completed effectively and within timeframes. Candidates should have proven experience in Clinical Operations, strong project management skills, and the ability to communicate at the executive level.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Demonstrated experience in global Clinical Operations, Development Operations, or similar.
• Familiar with systems used for clinical trials, especially eCRF and eTMF.
• Proven ability to manage projects that are strategic and on time.

Responsibilities

• Lead Clinical Systems Integration for the repatriation project.
• Create project plans and set up project governance.
• Ensure timely completion of integration activities.

Skills

Clinical Systems Experience

Program/Project Management

Executive Communication

Stakeholder Engagement

Meeting Facilitation

Tools

Medidata Rave

Veeva

Microsoft Office Suite

Job description

Consultant, Clinical Systems Integration, Study Repatriation

Consultant, Clinical Systems Integration, Study Repatriation

Direct message the job poster from Eliassen Group

Consultant, Clinical Systems Integration, Pharma Clinical Operations, Study Repatriation Project

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our Global F500 Pharma Client is seeking a Consultant skilled in Clinical Systems Project Management to lead a Clinical Systems Integration workstream that is part of a critical clinical study repatriation project, where our client is moving a clinical oncology program back in house from a CRO (contract research organization). The scope of this engagement is focused on the clinical systems integration: transitioning the CRO’s eCRF (electronic Case Report Form) and eTMF (electronic Trial Master File) to our client’s (the sponsor’s).

This critical Consultant will serve as the Lead/Project Manager for Clinical Systems Integration on this project, partnering cross-functionally with internal teams (Clin Ops/Clinical Study Team, Data Sciences, IT) along with facilitating external engagement with the CRO. Key responsibilities include: creating a project plan, setting up project governance with key stakeholders, and leading the execution of the systems integration to ensure all activities are completed in a timely fashion with minimal impact to clinical sites.

This role will report into our client’s Head of Clinical Operations/Program Lead.

MUST HAVES – QUALIFICATION SUMMARY

• F500 Global Pharma Clin Ops/Dev Ops Experience. This Individual must have demonstrated experience in a global Clinical Operations, Development Operations, Operational Excellence, or similar organization.
• Clinical Systems Experience: Demonstrated with a comprehensive understanding of systems used for clinical trials eCRF and eTMF, particularly familiar with medidata Rave and Veeva
• Demonstrated Program/Project Management: Demonstrated ability to implement projects of strategic importance on time and on budget. Meeting facilitation skills (personal organization, advanced preparation, and follow-up). Strong command of the full Microsoft Office suite, particularly Excel and PowerPoint
• Executive Communication and Presentation. The Consultant must communicate and present at the executive level: proficiency in stakeholder buy-in, strong cross functional communication, organizational navigation, building rapport across functions

NICE-TO-HAVES

• OCM/Change Management Experience. The ideal candidate will have experience rolling out and encouraging adoption of new processes, procedures, and tools. Demonstrated proficiency in obtaining alignment and managing change to gain adoption.
• Professional Consulting Experience
• CRO Management/Oversight Experience

TRAVEL & LOCATION

REMOTE

START & TERM

Immediate start. Initial 6-month term, possibility for extension into 2026

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Project Management

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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