Associate, Study Management

Description

• Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
• Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s)
• Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
• Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
• Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing
• Ensure inspection readiness and participate in related activities
• Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
• Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
• Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
• CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
• EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight
• Management of investigational product and other associated study supplies
• Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors
• Support global submission strategies
• Support process improvement initiatives or serve as a subject matter expert and/or mentor

Qualifications

• Bachelor’s Degree or OUS equivalent required
• Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
• Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Experienced user of systems such as EDC, IRT, CTMS, and eTMF
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study
• Excellent organizational and time management skills, strong attention to detail.
• Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
• Proactive, collaborative mindset
• Ability to work independently in a fast-paced global team environment
• Preferred: Exposure to study initiation through completion activities; global study exposure