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OGC (Outside General Counsel LLP) · 9 hours ago

Clinical Trials Partner

United States

Full-time

Remote

Senior Level, Lead/Staff

10+ years exp

Outside GC is a leading provider of on-demand general counsel services, offering innovative legal solutions for businesses. They are seeking a Clinical Trials Partner with extensive experience in corporate legal practice and specialized expertise in clinical trial agreements and life sciences clients.

Legal

Responsibilities

Significant experience drafting and negotiating clinical trial agreements, contract research agreements, and sponsored research agreements for biotech, pharma, and academic research institutions

Proven track record supporting life sciences clients through all phases of clinical development, including vendor and manufacturing agreements, software and data licensing, and regulatory infrastructure

Deep understanding of multi-site research frameworks, including IRB reliance arrangements and compliance with NIH’s Single IRB Review Policy

Skilled in navigating complex regulatory environments involving human subject protections, research misconduct, and HIPAA compliance

Experience working with academic medical centers, hospitals, and federal research agencies to design and implement streamlined, scalable contracting and compliance protocols

Familiarity with secondary use of clinical trial data, data de-identification, and data sharing agreements (DSAs, DTAs)

Demonstrated success as a practical, business-focused, and responsive legal partner

Qualification

Clinical trial agreementsLife sciences legal supportRegulatory complianceContract negotiationData sharing agreementsBusiness-focused legal partnerJ.D. degreeState bar membership

Required

At least 10+ years of corporate legal practice, including experience as an in-house attorney, serving as a General Counsel and/or in another senior in-house legal role, and 3+ years of law firm training

Significant experience drafting and negotiating clinical trial agreements, contract research agreements, and sponsored research agreements for biotech, pharma, and academic research institutions

Deep understanding of multi-site research frameworks, including IRB reliance arrangements and compliance with NIH's Single IRB Review Policy

Skilled in navigating complex regulatory environments involving human subject protections, research misconduct, and HIPAA compliance

Experience working with academic medical centers, hospitals, and federal research agencies to design and implement streamlined, scalable contracting and compliance protocols

Familiarity with secondary use of clinical trial data, data de-identification, and data sharing agreements (DSAs, DTAs)

Demonstrated success as a practical, business-focused, and responsive legal partner

J.D. from a nationally accredited law school

State bar membership in state where reside/practice

Company

OGC (Outside General Counsel LLP)

OGC (Outside General Counsel LLP) is a unique law firm that offers the relationship and experience of a traditional law firm with the cost savings and speed of an alternative legal services provider.

Founded in 2002

Boston, Massachusetts, USA

51-200 employees