Associate Director, Clinical Site Liaison

Role Summary:

The Clinical Site Liaison is responsible for developing and nurturing strong Dyne Therapeutics – Clinical Trial Site relationships while also optimizing site performance, particularly enrollment, and overseeing CRO site management and monitoring activities, using a risk-based approach. The primary goal of this role is to build/support site relationships while also ensuring quality monitoring oversight and delivery of data of high integrity. The individual in this role is responsible for working directly with the internal study teams, CRO partners and clinical trial sites. 
 
Primary Responsibilities Include: 

Site Relationship Management 

• Enhance the development and maintenance of Dyne’s relationships with clinical investigators and site staff  

• Provide an interface among study sites, Dyne Therapeutics and CRO partners to create an optimal environment for clinical trials, enabling timely and high-quality output 

• Coordinate regular, fit for purpose, communication with clinical sites to align interactions with CRO and relevant internal stakeholders to assure a harmonized approach to site relationship and optimize site performance and quality delivery 

• May attend SIVs and Motivational/Booster visits/calls in collaboration with CRO partner 

 Recruitment Support 

• Maintain an operational knowledge of the protocol(s), answer site/CRO questions as applicable and assist in the escalation process in connecting site/CRO to Dyne Therapeutics personnel 

• Leverage experience and deep insight from interactions with clinical sites to provide strategic input on effective recruitment, outreach, and optimization strategies. 

• Maintain and assist with the development of plans and tools to carry out these strategies, as appropriate 

Monitoring Support 

• In collaboration with CRO partners and as approved by the Clinical Operations Study Lead (COSL), perform on-site visits in support of continued site engagement and data quality, identify and remove barriers to performance and to oversee on-site outsourced monitoring activities 

• Document and communicate observations from onsite monitoring activities (such as key areas of risks and noncompliance) 

• Provide ongoing risk assessment review of available data resources, review the site performance/CRO monitoring performance to identify trends, risks, and opportunities. 

• In collaboration with the COSL, perform review of monitoring visit reports (on-site and central review reports) completed by CRO partner 

• Contribute to process improvements and knowledge/ sharing of best practices 

Education and Skills Requirements: 

• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable 

• Strong knowledge of ICH/GCP 

• At least 8 years of relevant clinical trial research experience 

• Onsite/central monitoring and/or clinical lead/study-management experience 

• Clinical site facing experience required 

• Monitoring experience in rare disease preferred 

• Biotech or pharma industry experience is required 

• Experience overseeing/managing outsourced site management and monitoring activities 

• Excellent verbal and written communication skills 

• Excellent attention to details 

• Ability to travel, 30% or more frequently at times