Position Overview:
The Clinical Trial Manager will be a key member of Acrivon Therapeutics' Clinical Operations Team and will be responsible for providing oversight to the ARC-386 Phase II clinical trial. This position will be based in Watertown, MA.
The Clinical Trial Manager position focuses on strategic planning, implementation, and management of a complex clinical trial. Dedicated to overseeing trials from start-up through close-out, fostering relationships with investigator sites, vendors, cross-functional colleagues, and consultants to ensure GCP/ICH compliance and timely deliverables.
Duties and Responsibilities:
- Oversees site initiation, subject enrollment, clinical monitoring, compliance at clinical sites, and metrics management with CROs, central labs, and external vendors.
- Ensures high-quality execution throughout clinical trial initiation, conduct, and closure.
- Manages study budgets, contracts with vendors, and negotiates agreements to track and control costs effectively.
- Guides cross-functional teams in achieving study timelines, strategies, goals, and quality benchmarks.
- Evaluates and ensures effective oversight of Contract Research Organizations (CROs) and other vendors, fostering strong partnerships and accountability.
- Communicates effectively with study team and sites to maintain project momentum, direction and team effectiveness.
- Updates stakeholders on trial progress to align expectations, priorities, and deliverables.
- Contributes to study-level budget development and takes responsibility for budget management.
- Identifies and addresses risks associated with clinical studies and investigator sites, implementing corrective actions or escalations as needed.
- Lead operational activities detailed in study plans, SOPs, and other study-related documents.
- Reviews / contribute to critical study documents, including protocols, manuals, informed consent forms, and operational materials.
- Assesses monitoring visit reports to verify site training adequacy and resolve any outstanding issues promptly.
- Lead study team's cross-functional vendor oversight efforts.
Requirements and Qualifications:
- Minimum of a bachelor's degree in a scientific or health-related discipline.
- Minimum of 3+ years of Clinical Operations and Clinical Trial Management experience at a contract research organization, biotech or pharmaceutical company preferably in early to mid-phase oncology
- Proven leadership skills managing cross-functionally in a matrix environment.
- Demonstrated ability to build strong relationships with internal / external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
- Mature, level-headed and organized with a can-do disposition.
- Strong verbal and written communication skills with ability to communicate and work productively in a team environment.
- Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel
- Proven ability to multi-task and work collaboratively as well as independently.
- Ability to organize and manage multiple priorities required.
