Regulatory Operations Lead, Clinical Trials (Hybrid)

West Virginia University

Evansdale (WV)

Hybrid

USD 90,000 - 130,000

Full time

5 days ago

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Benefits offered by this job

18 sick days

401(a) retirement with 6% match

Wellness programs

Job summary

West Virginia University seeks a Hybrid Regulatory Operations Manager for the WVU Cancer Institute to oversee regulatory lifecycle from site selection to closeout. The role emphasizes activation timelines, SOP development, and cross-functional collaboration with investigators and sponsors.

Strong regulatory knowledge and leadership are essential for success in this complex environment. The position offers hybrid work options, competitive benefits, and the opportunity to drive quality and

Qualifications

Bachelor's degree in a relevant field and 3+ years of clinical research or regulatory operations experience.
Experience in regulatory operations, protocol activation, and project management in clinical trials.
Ability to interpret complex regulations, sponsor requirements, and institutional policies.
Proficiency with CTMS, electronic regulatory systems, IRB platforms, and related tools.

Responsibilities

Provide supervisory oversight of protocol activation and regulatory management activities.
Lead staff, manage performance, training, and professional development.
Oversee site activation, feasibility, startup requirements, and regulatory documentation.
Ensure compliant regulatory documentation across CTMS and related systems.
Coordinate with investigators, sponsors, CROs, and institutional departments.
Monitor workload, timelines, and KPIs; drive process improvements.