Senior Study Start-Up Specialist

Summary

Join Cytokinetics, a late-stage biopharmaceutical company, as a Contract Senior Study Start-up Specialist (Sr SSUS). You will be responsible for all start-up activities on assigned studies, ensuring compliance with regulations and internal procedures. Key responsibilities include preparing Informed Consent Forms, obtaining approvals, analyzing study data, and collaborating with various stakeholders. You will partner with Clinical Trial Managers, support drug label preparation, and liaise with relevant authorities. The role also involves budget and contract negotiation. Cytokinetics values diversity and encourages applications from individuals who may not meet every qualification.

Requirements

• University Degree or equivalent, preferably in a medical/science-related field with 8+ years of related experience
• Demonstrated knowledge and understanding of clinical trials and experience in managing projects
• Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Responsibilities

• Update knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures
• Execute all start-up activities prior to site activation on assigned studies, according to CYTK standards and aligned with study/project requirements and timelines
• Prepare Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country
• Analyze and maintain study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
• Partner with Clinical Trial Managers to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations
• Support drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required
• Liaise and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies! laws, via innovative approaches
• Collaborate with CTMs to identify and track new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required
• Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country