Clinical Project Manager

Role Summary:

The Clinical Project Manager ensures that clinical strategies related to unblinded oversight of the trials are translated into operational plans and executed in line with clinical development plans (CDPs). This position is responsible for initiating and leading the unblinded aspect of clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives with agreed upon project priorities, timing, budget, and quality requirements. This position ensures the study blind is maintained and study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies and SOPs. This individual will be responsible for managing unblinded operations for multiple clinical studies of varying complexity. This role is expected to require up to 20% travel, including international travel.

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

Primary Responsibilities Include:

• Manage, independently or in partnership with other unblinded team members, 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
• Work closely with Dyne Supply, CMC and Quality Departments to ensure drug product and ancillary supplies/materials are shipped, properly stored and maintained and re-supplied as needed at sites to ensure on time treatment of patients
• Track site supply and projections for study drug usage on a per site, per patient basis in collaboration with the supply team
• Manage to resolution all IRT issues and site queries in partnership with CRO
• Act as unblinded data liaison resource for Dyne Biostatistics, Clinical Development, Data Management and other key blinded stakeholders
• Project manage all unblinded site issues, including but not limited to product complaints, storage capacity, pharmacy queries, and all site unblinded communications
• Carry out unblinded co-monitoring and site visits as deemed necessary (foreign travel expected)
• 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 activities to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and execution
• Participate in planning and conducting investigator meetings together with the CRO
• 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 unblinded 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

Education and Skills Requirements:

• B.A. or B.S. in a scientific discipline; advanced degree desirable
• Minimum of 3-5 years of clinical trial management experience in conducting Phase I-III International clinical trials in pharma/biotech organization
• Experience managing Blinded studies is required
• Scientifically and clinically astute with very strong project management skills
• Previous experience working with supply, CMC, quality and site pharmacies in an unblinded capacity preferred
• 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)
• Excellent written and oral communication skills
• Full competency in Microsoft Office programs

#LI-Onsite