Vice President, Trial Enablement Functions

Posted 5 Days Ago
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13 Locations
In-Office or Remote
Expert/Leader
Healthtech • Pharmaceutical
The Role
The VP of Trial Enablement Functions will oversee clinical services, drive strategic planning, operational performance, and employee leadership while ensuring compliance and quality in clinical operations.
Summary Generated by Built In
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 and the associated operational functions, including data sciences/data management, regulatory affairs, clinical safety, TMF operations, vendor management, and the process and training center of excellence. 
  • 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

Top Skills

Clinical Operations
Clinical Research
Data Sciences
Regulatory Compliance
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The Company
San Diego, CA
481 Employees
Year Founded: 1986

What We Do

From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.

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