Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out
Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings
Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable
Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials
Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. May coordinate study IRB/EC approvals
Support and oversee study-related work of Clinical Research Associates (CRAs) to ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, internal SOPs, FDA CFR, ICH/GCP guidelines, and in compliance with all applicable regulations.
Manage study deliverables and track study metrics including identifying potential risks to study timelines and/or conduct
Review, suggest edits and approve monitoring trip reports for studies. Escalate findings to senior management and/or leadership according to risk/severity.
Participate in data management activities, such as CRF development, training, and facilitating query resolution
Lead or contribute to organizational and departmental process development, improvement, and implementation
Provide guidance and mentorship to junior team members.

Requirements

Bachelor's degree or higher, or equivalent credentials
Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements
5+ years of clinical study management experience in sponsor, CRO and/or companion diagnostics, device manufacturer, IVD, or similar industry(ies) demonstrating effective and successful study management from study inception through close-out.
Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients.
Ability to work independently and effectively in a fast-paced environment
Strong work ethic and ability to deliver tasks on time
Proficient with office automation tools, especially Microsoft PowerPoint, Excel and Word.

Benefits

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development
Bonuses
Stock options

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical study managementprotocol developmentmonitoring plan developmentcase report form developmentrisk managementdata managementstudy deliverables trackingsite compliance oversightinvestigator qualificationcontracting management

Soft Skills

interpersonal skillsorganizational skillsprioritization skillscommunication skillsmentorshipcollaborationproblem-solvingleadershipindependencework ethic

Certifications

Bachelor's degreeGCP knowledgeICH guidelines knowledge