HireTalent
Real-World Data (RWD) / Real-World Evidence (RWE) Transformation Expert / Projec
HireTalent, Basking Ridge, New Jersey, us, 07920
Job Schedule
Remote / Hybrid (Flexible)
Title
Project Manager
Location
Remote / Hybrid at NJ (Flexible)
Duration
6 Months
Overview We are seeking a seasoned
RWD/RWE Transformation Expert / Project Manager
to support the operationalization of a new Real-World Data/Evidence governance framework and operating model across the organization. This role will partner closely with the PMO lead, medical and scientific stakeholders, and cross-functional business teams to ensure that new processes, roles, and decision pathways are effectively adopted and transitioned into business-as-usual (BAU) operations.
The ideal contractor will have deep expertise in real-world data/evidence environments along with strong experience in change management, operating model implementation, project management, and enterprise transformation.
Key Responsibilities Governance & Operating Model Deployment
Lead implementation of the new RWD/RWE governance model, including committees, roles, workflows, documentation, and decision rights.
Translate high-level governance designs into actionable processes and standard operating procedures (SOPs), guidance documents, and templates.
Ensure alignment of governance processes with regulatory, privacy, quality, and compliance requirements.
Partner with functional leaders to embed governance responsibilities and clarify accountability.
PMO & Transformation Leadership
Collaborate with the PMO lead to develop and execute a structured rollout plan with clear milestones, success metrics, and risk mitigation strategies.
Drive cross-functional coordination to ensure consistent adoption across R&D, OBU, CSPV, JBU, ASCA, and GCS.
Support PMO reporting, including progress updates, dashboards, status summaries, documentation of decisions, and change requests.
Identify barriers to adoption and design solutions to resolve operational challenges.
Change Management & Stakeholder Engagement
Create and deliver change management materials such as communication plans, training decks, onboarding guides, FAQs, and workflow maps.
Facilitate stakeholder workshops and training sessions on new processes.
Communicate complex RWD governance concepts clearly to both technical and non-technical audiences.
Build strong cross-functional relationships to drive alignment and promote responsible data use.
Transition to Business-as-Usual (BAU)
Define and refine BAU ownership, process maintenance responsibilities, and long-term governance checkpoints.
Ensure governance processes are stable, scalable, and fully integrated with existing operational workflows.
Monitor early BAU execution and support course corrections as needed.
Required Qualifications
10+ years of experience in RWD/RWE, data governance, project management, or related fields.
Proven track record in leading organizational change and operating model transformations.
Strong understanding of the RWD/E lifecycle (data acquisition, curation, access, analysis, evidence generation).
Experience collaborating with PMO leads or project/program managers on complex, multi-stakeholder initiatives.
Excellent communication, facilitation, and stakeholder management skills.
Ability to manage ambiguity and bring structure to evolving environments.
Preferred Qualifications
Experience in pharmaceutical or biotech RWE functions, data governance, or strategy.
Familiarity with compliance frameworks such as GDPR, HIPAA, and internal data access policies.
Background in management consulting, change management, or transformation programs.
Flexible availability based on project needs.
Willingness to attend occasional in-person workshops or stakeholder sessions.
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Remote / Hybrid (Flexible)
Title
Project Manager
Location
Remote / Hybrid at NJ (Flexible)
Duration
6 Months
Overview We are seeking a seasoned
RWD/RWE Transformation Expert / Project Manager
to support the operationalization of a new Real-World Data/Evidence governance framework and operating model across the organization. This role will partner closely with the PMO lead, medical and scientific stakeholders, and cross-functional business teams to ensure that new processes, roles, and decision pathways are effectively adopted and transitioned into business-as-usual (BAU) operations.
The ideal contractor will have deep expertise in real-world data/evidence environments along with strong experience in change management, operating model implementation, project management, and enterprise transformation.
Key Responsibilities Governance & Operating Model Deployment
Lead implementation of the new RWD/RWE governance model, including committees, roles, workflows, documentation, and decision rights.
Translate high-level governance designs into actionable processes and standard operating procedures (SOPs), guidance documents, and templates.
Ensure alignment of governance processes with regulatory, privacy, quality, and compliance requirements.
Partner with functional leaders to embed governance responsibilities and clarify accountability.
PMO & Transformation Leadership
Collaborate with the PMO lead to develop and execute a structured rollout plan with clear milestones, success metrics, and risk mitigation strategies.
Drive cross-functional coordination to ensure consistent adoption across R&D, OBU, CSPV, JBU, ASCA, and GCS.
Support PMO reporting, including progress updates, dashboards, status summaries, documentation of decisions, and change requests.
Identify barriers to adoption and design solutions to resolve operational challenges.
Change Management & Stakeholder Engagement
Create and deliver change management materials such as communication plans, training decks, onboarding guides, FAQs, and workflow maps.
Facilitate stakeholder workshops and training sessions on new processes.
Communicate complex RWD governance concepts clearly to both technical and non-technical audiences.
Build strong cross-functional relationships to drive alignment and promote responsible data use.
Transition to Business-as-Usual (BAU)
Define and refine BAU ownership, process maintenance responsibilities, and long-term governance checkpoints.
Ensure governance processes are stable, scalable, and fully integrated with existing operational workflows.
Monitor early BAU execution and support course corrections as needed.
Required Qualifications
10+ years of experience in RWD/RWE, data governance, project management, or related fields.
Proven track record in leading organizational change and operating model transformations.
Strong understanding of the RWD/E lifecycle (data acquisition, curation, access, analysis, evidence generation).
Experience collaborating with PMO leads or project/program managers on complex, multi-stakeholder initiatives.
Excellent communication, facilitation, and stakeholder management skills.
Ability to manage ambiguity and bring structure to evolving environments.
Preferred Qualifications
Experience in pharmaceutical or biotech RWE functions, data governance, or strategy.
Familiarity with compliance frameworks such as GDPR, HIPAA, and internal data access policies.
Background in management consulting, change management, or transformation programs.
Flexible availability based on project needs.
Willingness to attend occasional in-person workshops or stakeholder sessions.
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