Associate Director, Clinical Operations Study Lead

Primary Responsibilities

• Manage 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
• Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP
• 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
• Lead 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
• 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
• 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 (financial, project, etc.) for senior management on program status and issues as required
• Provide management, oversight, coaching, mentoring, and development to team of indirect reports supporting the clinical trials team and cross-functional teams

Education And Skills Requirements

• Undergraduate degree in a scientific or health related discipline
• Advanced scientific or business degree or equivalent experience desirable
• 8+ years of clinical trial management experience in conducting Phase I-III global clinical trials, preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline and budget expectations
• Prior site and/or monitoring experience is advantageous
• Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred
• Experience with rare disease and/or pediatric trials also 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
• Experience with clinical study budgets, accruals and forecasting
• Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
• Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships
• Ability to successfully engage and work collaboratively with clinical operations team members/colleagues and other functions, including Medical Affairs and Commercial, as necessary
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Excellent communication skills