Clinical Trial Manager

Role Summary

The Clinical Trial Manager ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). This position is responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne's policies and SOPs. This individual may be responsible for one medium complexity or multiple lower complexity clinical studies. This role may also support management of certain aspects of one or more high complexity studies led by a Clinical Study Lead.

This role is based in Waltham, MA without the possibility of being a remote role.

Responsibilities

• Manage, either independently or in partnership with COSL, all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
• Support the selection, oversight, and management of CROs and other vendors
• Monitor and assess vendor performance against contractual operational deliverables
• Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors
• Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track
• Participate in cross-functional teams and manage study team in partnership with the CRO
• Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
• Participate in planning and conducting investigator meetings together with the CRO
• Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time
• Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data
• Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required
• Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always "inspection ready"
• Prepare high-quality reports and dashboards (financial, project, etc.) for senior management on program status and issues as required

Qualifications

• Minimum of a B.A. or B.S. degree in life science or related discipline is required; advanced degree desirable
• Minimum of 3-5 years of clinical trial management experience in conducting Ph I-III International clinical trials in pharma/biotech organization
• Scientifically and clinically astute with very strong project management skills
• Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws
• Understand clinical study budgets, accruals and forecasting
• Experience with clinical studies in muscular dystrophies desirable
• Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
• Understand technical, scientific and medical information, to plan, organize, project manage and analyze data
• Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships
• Experience in vendor selection and overseeing studies being managed by a CRO
• Ability to successfully engage and work collaboratively with clinical operations team members/colleagues
• Excellent interpersonal and decision-making skills
• Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives
• Excellent planning, time management & coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Experience in working in a small organization
• Ability to travel for up to 20% is required (including overnight stays and international travel)
• Excellent written and oral communication skills
• Full competency in Microsoft Office programs

Education

Additional Requirements