Inactive
A

Alimentiv

Runs clinical trials for digestive disease treatments

Director Clinical Study Management - Project Management

Clinical Research OperationsPosted on Nov 1
Full-time€112k - €149.5k /yr

About the Job

Requirements

  • An undergraduate university degree (Bachelor or Honors Bachelor) and at least 10 years of related experience and training or continuous ongoing development, or a college diploma/degree and at least 15 years of related experience.
  • Deep experience in the contract research organization industry with full-service project management leadership, coaching, and leading a team.
  • Phase II experience is required; Phase III experience is highly desirable.
  • Significant financial resource management experience, including participation in budget setting, autonomous expenditure and/or revenue-generation decisions within company policy, or financial processing, reconciliation, and reporting.

Responsibilities

  • Provide leadership and oversight for global activities and timelines related to execution of full-service clinical trials, including oversight of project management and project finance teams.
  • Participate in developing and implementing organizational strategies, technologies, and best practices supporting customer service, staff development, quality information management reporting, and divisional goals aligned with the organization's direction.
  • Develop and improve policies and processes; oversee product quality, compliance monitoring, staff resource planning, staff and contractor performance management.
  • Represent project and finance teams with sponsors and clients throughout the project life cycle.
  • Ensure team members deliver timely, high-quality services and maintain service delivery processes in accordance with corporate and industry best practices and regulatory requirements.
  • Support business development through bid development and defense as required.
  • Participate in operational planning, identifying and advocating for the functional area and its stakeholders.
  • Guide departmental planning and implementation, translating strategic direction into measurable short- and long-term operational goals and targets.
  • Oversee or participate in project development with sponsors and functional directors, negotiating and delivering quality products; assess resource, financial, and safety requirements; assign resources; oversee trial conduct and information and data confidentiality; and support troubleshooting and resolution in alignment with corporate objectives.
  • Ensure sufficient project-level staffing and maintain utilization targets.
  • Represent project operations on cross-department planning initiatives.
  • Serve as a role model, motivator, and mentor to the Clinical Project Operations team; ensure functional areas are staffed with qualified personnel; and support managers and leaders with work allocation, resource planning, staff allocation, training and development, employee engagement, team development, and performance management, including staff evaluation, performance improvement, and lost-time management.
  • Act as the senior representative of the project operations team at client meetings.
  • Represent project operations at business development meetings, including bid defenses, general capabilities meetings, and scientific conferences.
  • Attend and present at investigator meetings as needed.
  • Collaborate with the leadership team to achieve excellence in project services, evaluate and implement recommendations to minimize organizational risk and meet regulatory and industry standards, and promote programs supporting organizational growth in clinical research and research services.
  • Plan, manage, advocate, and report on behalf of the department during budget and annual operational review processes, working with the senior leadership team.
  • Maintain knowledge of financial and regulatory risks and requirements related to department service delivery, and direct development of methods to review, monitor, and manage them.
  • Work with business development to prepare budgets and proposal text in response to requests for proposal, requests for information, and statements of work.
  • Oversee change-order development for full-service projects to ensure project costs are realized in line with work performed.

Desired Qualifications

  • Experience in gastrointestinal clinical trial project management is highly desirable.
  • Phase III experience is highly desirable.

About the Company

Alimentiv

Runs clinical trials for digestive disease treatments

Alimentiv runs clinical trials for pharmaceutical and biotechnology companies developing treatments for gastrointestinal diseases. Its contract research services cover study design, site monitoring and regulatory submissions, with medical imaging used to measure how patients respond to treatment. The company combines central image reading with tissue analysis and biomarker testing through sister laboratory AcelaBio. Sponsors pay for trial execution, scientific consulting and statistical services that support drug development from early studies through regulatory review. Founded in 1986, Alimentiv is headquartered in London, Ontario, and operates internationally.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
London, Canada
Founded
1986

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