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The Steely Group · 14 hours ago

Clinical Trial Manager

United States

Contract

Hybrid

Senior Level

$82/hr - $84/hr

6+ years exp

The Steely Group is seeking a Clinical Trial Manager who will ensure high-quality deliverables within timelines and budget. The role involves managing operational aspects of clinical trials, overseeing vendor relationships, and mentoring clinical operations staff.

ConsultingHealth CareHuman ResourcesMedicalStaffing Agency

Hiring Manager

Emma Bogart

Responsibilities

Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc. for assigned region(s) or study(s)

Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)

Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc

Lead, or actively contribute to, Study Management Team meetings

Identify study risks, develop and implement mitigation strategies

Oversee Trial Master File, Completeness Reviews, and Essential Document List

Support the study budgeting process, including the review of invoices and clinical trial financial accruals

Serve as a subject matter expert on initiatives and working groups

Mentors Clinical Operations Staff (Clinical Trial Associates, Specialists, CTMs), including onboarding of new hires

Qualification

Clinical Research ManagementStudy Start-upVendor ManagementRisk ManagementBudgeting ProcessPlanning SkillsOrganizational SkillsCommunication SkillsProblem SolvingRelationship Building

Required

Bachelor's degree or equivalent is required (scientific or healthcare discipline preferred)

Typically 6 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred

Fully proficient in the management and execution of clinical trials

Excellent planning, organizational, and communication skills

Able to handle multiple tasks and deadlines; and identify risks and issues and take appropriate actions

Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter organizational impact

Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites

10% travel may be required