SummaryWe are seeking a Clinical Trial Manager (CTM) to lead operational aspects of a clinical trial and support the Clinical Trial Leader (CTL), as required. This role will serve as a key member of the Clinical Trial Team (CTT) and as the primary contact for external parties and vendors. CTM may lead the cross-functional CTT for smaller and less complex trials or manage critical aspects of larger and more complex clinical trials under CTL leadership. In addition, CTM will be responsible for site management oversight for trials where no Site Management Leader (SML) is assigned.
In a fast-paced, small biotech environment, the CTM will operationally manage the set-up, conduct and reporting of clinical trials (or parts thereof) as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives.
The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.
Your Role:- Serve as a core member of the Clinical Trial Team (CTT) and act as deputy for the Clinical Trial Leader (CTL) during absences
- Organize and coordinate CTT meetings, including preparing agendas, recording minutes, and tracking follow-up actions
- Facilitate communication and collaboration within the team and with external partners such as Contract Research Organizations (CROs) and vendors
- Contribute to the development and maintenance of trial-level documents and operational plans, including project management, communication, risk management, and quality plans
- Establish and manage trial-related systems and processes (e.g., central laboratories, eCOA/ ePRO) in alignment with protocol requirements
- Monitor CRO/ vendor performance and ensure timely and accurate data integration, transfer, and reconciliation. Escalate issues to the CTL, as needed
- Identify risks and issues and support the development and implementation of mitigation strategies and action plans
- Maintain accurate and up-to-date trial information in systems and communication tools
- Set up and maintain clinical trial insurance in participating countries
- Coordinate with the global supply chain to ensure timely supply and distribution of devices and investigational medicinal products, comparator or co-medication to clinical sites
- Prepare and distribute trial-related correspondence and contribute to the development of materials for meetings, newsletters, and websites
- Lead logistical arrangements and support content development for external meetings such as investigator meetings and advisory boards
- Ensure ongoing inspection and audit readiness. Participate in internal audits and regulatory inspections, as required
- Support budget forecasting and accrual processes. Assist with invoice tracking, and processing in line with vendor contracts
- Act as CTL when assigned, leading cross-functional CTT to operationalize the protocol of a clinical trial
- Lead the development of site management oversight plan and ensure site management oversight including risk management for trials without assigned Site Management Lead (SML)
What You Bring: - 5+ years of trial management experience. Leadership experience (preferred)
- Bachelor's degree in Life Sciences, Pharmacy or related field
- Experience working in global clinical development organization
- Experience in Oncology development (preferred)
- Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
- Experience in outsourcing and oversight
- Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
- Knowledge of financial planning, tracking, and reporting
- Knowledge of trial risk assessment and management
- Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and site management metrics, KPIs, and KRIs
- Strong vendor management and project management skills
- Leadership skills with the ability to lead cross-functional teams
- Strong interpersonal and communication skills
- Strong analytical thinking and decision-making capabilities
- Willingness to travel, as required (typically 10-20%)
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Salary range
$120,000-$180,000 USD
