Lead the study team to design, develop, execute and deliver clinical studies.
Serve as a Clinical Operations representative at the program level and liaise cross-functionally.
Monitor progress of clinical study activities and report on them.
Lead the evaluation, selection, and oversight of CROs and other vendors.
Provides strategic and tactical guidance in risk management.
Contribute to writing and review of clinical documents on assigned program.
Liaise with clinical site staff and investigators to ensure optimal Sponsor-site relationships.
Direct initiatives to identify and implement best practices and continuous improvement plans.

Requirements

Bachelor’s degree required; in a scientific field helpful, advanced scientific degree a plus
8+ years Industry experience directly managing clinical trials required.
In-depth knowledge of clinical study operations, ICH-GCP Guidelines and other applicable regulatory requirements.
Demonstrated experience in study management/monitoring.
Experience mentoring and directing members of clinical operations teams.
Experience working with cross functional team members (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply Chain, Finance).
Intellectual curiosity: ability to think critically in a fast-paced environment.
Highly organized, detail-oriented, and self-motivated.
Strong verbal and written communication skills.

Benefits

99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
401(k) matching dollar-for-dollar up to 6% on eligible contributions.
Long-term stock incentives and ESPP.
Discretionary quarterly bonus.
Extremely flexible wellness benefit.
Generous PTO, paid holidays and company-wide shutdowns.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical study designclinical study executionclinical trial managementrisk managementclinical document writingstudy managementmonitoringvendor oversightCRO selectionregulatory compliance

Soft skills

leadershipcross-functional collaborationmentoringorganizational skillsdetail-orientedself-motivatedcritical thinkingcommunication skills