Senior Clinical Trial Manager - Chrysalis

About this role

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Sr. Clinical Trial Manager must have experience as a Global Study Lead in an outsourced model (i.e. providing oversight to CROs and vendors), as well as managing vendors, with a focus on study start up and study execution to ensure vendor/system/and cross functional integration throughout the study. The Sr. CTM is responsible for the successful execution of a clinical trial from protocol concept through clinical study report, ensuring completion of all study deliverables, including proactive risk/issue identification and mitigations. Ideally, the candidate has rare disease and pediatric experience (preferable, not required), as well as dose escalating/dose finding study experience that includes Safety Monitoring Committee (SMC).

Key Responsibilities:

• Leading a cross-functional clinical study team and responsible for leading and managing all aspects of assigned clinical study(ies) with oversight to the partner CROs and vendors, by ensuring assigned studies are conducted according to the protocol, GCP and within timelines and budget per the Clinical Development Plan (CDP).

• Oversees and lead role in the identification process of conducting study feasibility, selecting sites/countries and ensuring that sites are activated in a timely manner

• Responsible for overseeing selection/qualification of vendors, set up of these vendors is done correctly. Ensures where necessary that UATs are completed effectively where needed

• Provides input into clinical study protocols, informed consent forms (ICFs) and other clinical study documents.

• Responsible for overseeing development of study operational plans to ensure study compliance and quality is maintained.

• Oversees the development of and adherence to clinical study timelines as per the Clinical Development Plan (CDP) and collaborates with internal functional stakeholders for alignment.

• Proactively identify study risks and coordinate risk identification and mitigations with the study team, CRO and vendors and escalate risks as needed.

• Provides effective vendor and CRO oversight and ensures that the study is being completed in compliance to the protocol and GCP

• Coordinates the relevant and timely exchange of study status with internal functional stakeholders to support clinical study delivery per the CDP.

• Coordinates with CMC regarding drug forecasting and supply of drug products to sites.

• Supports timely and efficient databases lock (including interim locks) by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts.

• Adheres to clinical study budgeting process and provides input to finance on budget accruals and forecasts.

• Participates in clinical study scenario planning by estimating timelines and cost. Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.

• Demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and study team leadership capabilities.

• Ensure Trial Master File (TMF) meets inspection readiness requirements.

• Provides and reviews study dashboards with cross functional team.

• Actively participates in the development of department initiatives, including the development /definition of SOPs and processes.

Required Skills & Experience:

• Bachelor’s degree or h