Head, Regional Clinical Operations - Americas

Your Role:
The Head of Regional Clinical Operations for the Americas you lead Site Relationship & Operational Lead and the Clinical Research Manager teams within the region.
As head of Site Relationship & Operational Leads in the Americas, you are accountable for:
Providing direction to the Site Relationship & Operational Leads (SROLs) in the region to ensure that global trials are conducted with concern for ethics and patient safety and in compliance with Good Clinical Practice, internal policies and guidelines and local regulations.
Ensuring that SROLs oversee CRO work as well as develop and maintain excellent relationships with trial sites and the company's commercial organizations in the region
Continuously monitoring performance of assigned staff against applicable practices and expectations, addressing any deficiency and providing coaching and mentoring as required to maintain high-performance teams
Ensuring development of communication skills of all SROLs under responsibility
As head of Clinical Research Managers (CRMs) in the Americas,
be accountable for clinical trial management of global Phase IV, local and/or regional clinical trials of marketed products, and registrational studies for local products for all countries within own region and therapeutic areas which includes:
Ensuring that local/regional clinical trials are executed and managed based on agreed budget, timelines and quality standards
Ensuring compliance with local/regional guidelines, GCP as well as alignment of systems and processes to Company and global standards (performance, quality, timelines)
Ensuring that the assigned staff members adequately fulfill their tasks and responsibilities within clinical trials according to agreed timelines, quality and budget and according to ICH-GCP, regulatory requirements and Company standards
Supporting assigned staff in reaching clinical trial objectives
Providing an interface with regional/local Medical Affairs organizations and ensuring alignment on trial strategy
Manage the implementation and integration of organizational changes or new roles and responsibilities and adjust and incorporate changes to existing roles as appropriate.
Lead and steer site management as well as central coordination for developing long-term relationships with clinical investigators, enhancing the image and reputation of the company and for providing an interface between the company, the investigator and the service provider across multiple countries
Anticipate and mitigate issues or risks in the region or countries with sites/investigators as well as CROs
Lead and coordinate study management for local clinical trials across countries in own region, phases and therapy areas
Ensure alignment and support of CRMs vs. local / regional commercial organization priorities for clinical trials
Ensure and drive CRMs support for local medical strategy across the portfolio within own countries
Oversee CRMs work/interaction with CROs in county to ensure local / regional trials are delivered within desired quality, timelines, and costs
Who You Are:
Advanced degree in life sciences or business
More than 10 years of industry experience with a biotech, pharmaceutical or CRO, including experience in clinical trial management and working in or managing clinical monitoring
At least 5 years of people and resource management, ideally in a multifunctional or multinational setting
Demonstrated excellent organizational ability: time management, prioritization, able to handle and oversee multiple tasks simultaneously
Demonstrated solid interpersonal skills
Demonstrated good people management and coaching skills.
Deep understanding of regional aspects/variability of regulatory aspects and conduct of clinical trials in countries / across geographies
Ability to manage SROLs and CRMs across multiple countries across the entire portfolio
Long-term experience in managing CROs
Understanding of critical Health Care stakeholders across geographies
Ability for domestic and international travel up to 50% of the time
Job Requisition ID: 183959
Location: Rockland
Career Level: E - Professional (10+ years)
Working time model: full-time

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