Clinical Research Engagement Lead - Northeast Region (Cincinnati, OH)
Roche
Summary
As a Clinical Research Engagement Lead (CREL) at Roche, you will act as the ultimate strategic partner and primary face of Roche Clinical Operations within your market. This is not a traditional coordination role—you are the champion of a "ONE Roche" approach, wielding clinical operational expertise and deep Disease Area (DA) knowledge to build elite, high-trust partnerships with clinical trial sites.
Job description
The Opportunity
You will bridge the gap between strategy and execution across the entire trial lifecycle—from early development to late-stage delivery—ensuring our clinical assets are executed with maximum speed, efficiency, and clinical quality. In this role you will have the opportunity to:
Strategic Planning & Alignment
Develops and executes country-level site engagement strategies aligned with internal priorities, making strategic investment decisions regarding Principal Investigators and clinical sites to support the broader portfolio. Experience with site budget negotiation, tracking clinical grant payments, and forecasting site-level resource needs.
Early Feasibility & Study Set-Up
Conducts early, strategic landscaping and site engagement (in-person or remote) during the protocol concept and study set-up phases to identify optimal sites, evaluate country feasibility, and accelerate recruitment. Demonstrated ability to drive study start-up metrics, optimize cycle times, and utilize enrollment forecasting tools to ensure site milestones are met on schedule.
Relationship Management & Site Support
Builds deep, multi-stakeholder relationships at strategic sites (including investigators, pharmacists, and administration), acting as a "site champion" and Primary Point of Contact to maintain cross-study consistency and address site needs. Must have and demonstrate exceptional communication skills both oral and written.
Issue Escalation & Performance Oversight
Serves as the local escalation point for study challenges, monitors investigator performance, supports motivational site visits to boost recruitment, and manages sensitive communications during premature site closures. Be able to manage and navigate sensitive and complex situations under unknown or un-clear circumstances.
Cross-Functional Collaboration & Reporting
Partners seamlessly with internal teams (e.g., Medical Affairs, Study Start-Up) and CROs to ensure unified site communication, while maintaining meticulous documentation of site visits and interactions in central systems (e.g., Veeva).
Portfolio Oversight & Compliance
Manages assigned local/global clinical studies by overseeing CRO performance, mitigating timeline or operational risks, ensuring eTMF completeness, and maintaining continuous inspection readiness.
Digital Clinical Trial
Focus on driving adoption of DCT and digital solutions with our sites i.e. eConsent, eSource, Remote Data Entry, etc. Actively pursuing and reviewing digital tools with sites to examine challenges and provide solutions.
Who you are
- Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent.
- Minimum 5+ years of relevant clinical research or clinical operations experience in pharmaceutical, biotech or related industry; Sponsor experience preferred
- Experience in end-to-end product development and expert understanding of ICH/GCP are both essential.
- Understanding of end-to-end clinical trial processes, including monitoring, and strong knowledge of clinical trial regulations and guidelines.
- Proven track record in managing site relationships and overseeing complex clinical trials.
- Exceptional interpersonal, cross-functional, negotiation, and influencing skills with a proven track record of building high-trust, sustainable relationships with internal stakeholders, CROs, and site personnel.
- Ability and willingness to travel domestically between 30-50% dependent on business or site needs.
Preferred qualifications
- Postgraduate degree or master’s degree will be valued but not required
- Prior experience working directly with local trial sites and a strong existing network within the regional healthcare ecosystem is a strong plus
- Highly experienced in early and late phase oncology
- Highly experienced across multiple disciplines/TAs in non-oncology
This role is regional. Applicants should reside within 30 miles of a major airport and should reside within 50 miles of the Primary Location. Preference will be given to applicants who reside within those parameters.
Relocation benefits are not available for this posting
Requirements
- Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent.
- Minimum 5+ years of relevant clinical research or clinical operations experience in pharmaceutical, biotech or related industry; Sponsor experience preferred
- Experience in end-to-end product development and expert understanding of ICH/GCP are both essential.
- Understanding of end-to-end clinical trial processes, including monitoring, and strong knowledge of clinical trial regulations and guidelines.
- Proven track record in managing site relationships and overseeing complex clinical trials.
- Exceptional interpersonal, cross-functional, negotiation, and influencing skills with a proven track record of building high-trust, sustainable relationships with internal stakeholders, CROs, and site personnel.
- Ability and willingness to travel domestically between 30-50% dependent on business or site needs.
Benefits
- Discretionary annual bonus
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.