Manager, Study

Role Summary

The Manager, Study Start-up will serve as an expert across the study start-up, country, and site activation landscape. The role creates project plans for efficient implementation and oversight of processes, tools, and technologies to accelerate start-up activities while ensuring quality and compliance. This position leads study and site activation oversight by removing complexity, identifying and mitigating risks, and clearing obstacles that may impact study and corporate milestones, using strong project management, organizational, and communication skills to share best practices with study teams, CROs, and internal stakeholders across Clinical Operations.

• Drive global study start-up and site activation activities, milestone oversight, and CRO delivery.
• Support new vendor and CRO identification, evaluation, and selection, including RFP processes, bid defenses, and selection.
• Support vendor and CRO contract negotiations and downstream changes in scope.
• Develop and deliver the global study startup plan by partnering with the CRO Study Startup team.
• Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables, timelines, and performance objectives.
• Lead development of procedures and tools to enhance internal start-up capabilities and drive efficiencies, including site contract and budget templates.
• Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving goals.
• Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts.
• Collaborate with internal stakeholders to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios, and accurate operational planning.
• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of efficient study startup services.
• Partner with CRO to ensure efficient start-up processes and transparent reporting to deliver best in practice country and site activations.
• Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues.
• Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation.
• Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements.
• Build and maintain study start-up, country and site activation best practices.
• Support the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency.
• Oversee dedicated TMF Document Specialist in the overall set-up and maintenance of the Trial Master File across trials.
• Oversee dedicated staff responsible for site budget and contract negotiations.

• Bachelor’s Degree in Science or related discipline.
• Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies, preferably in oncology.
• Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment.
• Strong knowledge of GCP and a solid understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.
• Significant experience in leading global study start-up and site activation activities is required.
• Strong knowledge of EU CTIS regulatory processes and timelines.
• Must have prior experience:
  Working for or with CROs and cross-functional teams;
  Writing RFPs and managing CRO selection process;
  Reviewing, assessing, and managing CRO and other vendor/service provider SOWs and budgets;
  Reviewing, assessing, and negotiating site budgets and contracts.

• Bachelor’s Degree in Science or related discipline.