What are the responsibilities and job description for the Strategic Partnering Infrastructure Lead position at Advanced Recruiting Partners?
Our client is seeking a Strategic Partnering Infrastructure Lead for a 12-month contract engagement to support the implementation of a new clinical outsourcing operating model. This individual will play a critical role in designing and building the operational infrastructure required to successfully transition to new ways of working with Contract Research Organizations (CROs) and Functional Service Providers (FSPs).
The ideal candidate will bring a strong clinical operations background combined with demonstrated experience in process improvement, SOP development, and cross-functional project leadership. This individual will partner with subject matter experts (SMEs) across Clinical Operations and strategic external partners to develop process maps, standard operating procedures, governance frameworks, training materials, and supporting documentation that enable successful adoption of the new outsourcing model.
Key Responsibilities
Infrastructure & Process Development
- Lead the development and implementation of operational infrastructure supporting the organization's new clinical outsourcing model.
- Facilitate the creation, revision, and maintenance of process maps, SOPs, work instructions, templates, tools, and guidance documents.
- Assess current-state processes and design future-state workflows that optimize collaboration between internal teams, CRO partners, and FSP providers.
- Ensure process documentation aligns with applicable regulatory requirements, GCP standards, and organizational policies.
Cross-Functional Project Leadership
- Serve as the project lead coordinating activities across multiple functional SMEs to drive timely completion of process and documentation updates.
- Facilitate working sessions, stakeholder reviews, decision-making forums, and process design workshops.
- Develop project plans, timelines, and deliverables while proactively identifying and mitigating risks.
- Drive alignment and consistency across functions impacted by the outsourcing transformation initiative.
Strategic Partnering & Change Management
- Partner with internal clinical stakeholders, Strategic Partnering Leads, CROs, and FSP providers to define and implement new ways of working.
- Capture lessons learned and best practices from strategic partnerships and incorporate them into process improvements.
- Support governance activities and operational readiness efforts associated with outsourcing model implementation.
- Contribute to onboarding, training, and change management activities to ensure successful adoption of new processes.
Continuous Improvement & Compliance
- Identify opportunities to improve efficiency, quality, and effectiveness of clinical development processes.
- Support inspection readiness and quality initiatives related to outsourced clinical operations activities.
- Ensure documentation and processes support compliance with internal standards and regulatory expectations.
- Monitor implementation effectiveness and recommend enhancements based on stakeholder feedback and operational metrics.
Qualifications
Required
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- 8 years of Clinical Operations experience within pharmaceutical, biotechnology, CRO, or related clinical research environments.
- Strong understanding of clinical trial conduct, ICH-GCP guidelines, and clinical development processes.
- Demonstrated experience developing process maps, SOPs, and operational documentation.
- Proven ability to lead cross-functional projects and influence stakeholders without direct authority.
- Experience working within outsourced clinical development models and managing CRO/FSP relationships.
- Excellent facilitation, communication, and organizational skills.
- Strong analytical and problem-solving capabilities.
Preferred
- Experience supporting large-scale operating model transformations or outsourcing initiatives.
- Experience with process improvement methodologies and change management practices.
- Prior experience working in strategic CRO partnership environments.
- Advanced degree in a scientific, business, or healthcare-related field.
- PMP, Lean Six Sigma, or related project management/process improvement certification.
Key Competencies
- Clinical Operations expertise
- Process Mapping & SOP Development
- Project Management
- Stakeholder Engagement & Influence
- Strategic Thinking
- Change Management
- Cross-Functional Leadership