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Company

Cytokinetics · 20 hours ago

Contract - Senior Study Startup Specialist (SSUS)

United States

Contract

Remote

Senior Level, Lead/Staff

8+ years exp

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BiopharmaBiotechnology

H1B Sponsor Likely

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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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical Trials ManagementRegulatory ComplianceStudy Start-up ActivitiesInformed Consent PreparationInternational Council for Harmonization (ICH)Budget NegotiationData AnalysisProject ManagementMedical/Science DegreeContinuous Improvement

Required

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).

Company

Cytokinetics

Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.

Founded in 1998

South San Francisco, California, USA

201-500 employees

http://cytokinetics.com

H1B Sponsorship

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Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (1)

2022 (6)

2021 (8)

2020 (4)