Associate Director, Country Site & Operations FSP Oversight Manager

Biogen Idec

Biotechnologie

6349 Baar, Zug - Switzerland

Abteilungsleiter / Manager

Experteer Overview

In this role, you will lead the CSO’s insourcing model for FSP staff across country and site operations. You will partner with CSO leadership and cross-functional teams to ensure consistent processes, clear roles, and high-quality delivery in clinical trial execution. You’ll shape operational strategy, oversee trainer onboarding, and drive continuous improvement across regions. This position offers impact on trial execution at scale and alignment with global governance, quality, and delivery expectations. A key hook is enabling efficient, site-centric execution within a growing biopharma landscape.

Verantwortungsbereiche

Manage 20–25 FSP staff across the clinical portfolio to support CSO objectives
Lead resource forecasting, assignment, and prioritization for regional delivery and annual plan commitments
Develop and implement role-specific processes, guidance, and quality expectations
Design and implement training and onboarding programs with FSP vendors and stakeholders
Oversee onboarding/offboarding of FSP resources ensuring role clarity and policy compliance
Represent CSO in FSP vendor governance, oversight, and performance forums
Monitor and report FSP performance metrics, quality indicators, workload trends, and delivery risks
Partner with CSO leaders, study teams, Medical, Quality, and other stakeholders to align on goals and continuous improvement

Zentrale Anforderungen

Approximately 12 years of clinical research, clinical operations, country/site operations, or project management experience
Experience managing resources, vendors, and cross-functional stakeholders; line management advantageous
Proven ability to oversee FSP staff, including resource planning, training, performance management, and workload prioritization
Strong cross-functional knowledge of drug development including clinical trial phases I–IV
Effective line management and mentoring skills
Excellent leadership, communication, and organizational skills
In-depth knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development
Strong project management capabilities

Collaborative mindset Strong leadership and mentoring Effective communication across geographies Clinical operations oversight Resource planning and forecasting Vendor governance and performance management

Stellenbeschreibung

In this role, you will lead the CSO’s insourcing model for FSP staff across country and site operations. You will partner with CSO leadershi…

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