A Global Studies Manager is needed for a 36-month/3-year contract position at major biotech company in Northern California.Main Responsibilities and Accountabilities: • Provides direction and leadership to one or more clinical operations teams Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management. • Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables. • Creates team culture and promotes team spirit. • Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams. • In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members. • Oversees the development and maintenance of study specific manuals created by the GSA. • Contributes to the development and management of the study timelines, resources, budget, risk and quality plans • Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL. • Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans. • Communicates variances in the budget and action plan for resolution to the GSL. • Establishes study milestones and ensures accurate tracking and reporting of study metrics. • Provides operational input into the development of protocol feasibility questionnairesEducation and Experience: Life sciences degree or nursing equivalent and 5-7 years of experience in a clinical research/a healthcare environment.Experience and Skills:• Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock. • Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans. • Good knowledge of ICH GCP Proven ability to successfully achieve results within a multi-cultural and geographically diverse team. • Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments. • Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.• Project Management • Collaboration and Teamwork • Negotiating Communication • Personal Organization
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