As the VP, Trial Enablement Functions, you'll direct and shape Alimentiv's global Clinical Services team. You'll oversee the transformation of strategic decisions into operational plans, ensuring timely and smooth implementations that, aligned with organizational direction and goals, adhere to all compliance guidelines and minimize risk while protecting both the financial health and the reputation of the Organization. expertise supporting the leadership team in the areas of clinical research, regulatory adherence, site/product/service development, quality, delivery, and safety.
As the VP, Trial Enablement Functions, you'll direct and shape Alimentiv's global Clinical Services team. You'll oversee the transformation of strategic decisions into operational plans, ensuring timely and smooth implementations that, aligned with organizational direction and goals, adhere to all compliance guidelines and minimize risk while protecting both the financial health and the reputation of the Organization. expertise supporting the leadership team in the areas of clinical research, regulatory adherence, site/product/service development, quality, delivery, and safety.
Responsibilities
As a VP, Trial Enablement Function, you'll own the following:
1. Strategic/Operational Planning & Growth
In conjunction with the Executive team and the Board of Directors, participate in strategic and operational decision processes, ensuring continued alignment of clinical operations with organizational goals and direction.
Provide direction, oversight, support and approval to senior management team during short- and long-term Clinical Services planning and development.
Act as primary contact with Sponsors and Research Partners.
Assist in corporate promotion, sponsor relations for complex international bids/startups, as needed.
In conjunction with the senior leadership team, identify/validate future resource needs.
Approve/oversee implementation of clinical improvements and/or expansions
Stay current on industry best practices and current environment.
2. Operational Performance/Quality and Project Support
Assume the primary responsibility for the performance of the organization's Clinical Services division, including clinical study management, clinical operations, data sciences, regulatory affairs and clinical safety.
Provide direction and guidance to unit managers and senior leaders in the areas of issue escalation/resolution and prioritization, performance/product improvement, risk management and product/service quality, ensuring programs are in place and adhere to corporate, sponsor, industry and regulatory requirements and best practices.
Oversee and/or approve clinical research policies, processes, systems, guidelines and contracts related to product/service development, delivery and quality.
Drive quality and continuous improvement initiatives through unit managers and senior leaders, leveraging key performance indicators, metrics and the department/individual goal setting mechanism to generate high impact financial and non-financial value.
3. Sponsor/Public Relations
Represent and support the Corporation with Sponsors, at industry and/or academic events, actively promoting the organization and its services.
Actively support the VP of Business Development by seeking out and identifying potential growth opportunities.
Support complex multi-country project development by providing expertise and guidance that support recruitment, procurement and training activities.
Develop and/or oversee sponsor/client communications, content and delivery.
In conjunction with the business development and marketing team, assist with creating and/orapprovingclinicalresearchmediareleasesandotherclinicalresearch related external communications.
4. Employee Leadership and Development
Manage and budget for the activities of the Clinical Research team, ensuring adequate staffing with qualified personnel.
Provide ongoing support to staff in the areas of work allocation, resource planning training and development, process development, expense management, employee engagement and performance management {staff role development, evaluations, performance improvement and lost time management).
Qualifications
Education & Experience: Undergraduate degree (Bachelor) and a minimum of 15 years related experience and/or training/continuous ongoing development OR post-graduate degree/professional certification and a minimum of 10 years of related experience and training/continuous ongoing development
Exceptional leadership skills and experience, coaching a team while imparting a client-centric mindset
Contract Research Organization experience required
Expertise in operations leadership capacity, specifically in service development, delivery, and quality
Expertise in operationalizing clinical operations aligned with organizational goals
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