Director, Clinical Study Management (Project Management)

Job Description

Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.

If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you!

Responsible for providing leadership and oversight to support the global activities and timelines related to execution of full-service clinical trials, including oversight of project management and project finance teams. As part of the senior leadership team, participate in the development and implementation of organizational strategies, technologies and best practices that ensure superior customer service, staff development, quality information management reporting and effective, efficient divisional short- and long-term goals that align with the organization's vision, mission, and direction.

Role includes policy and process development and improvement, product quality, compliance monitoring, staff resource planning, staff, and contractor performance management. To provide support, expertise and represent project and finance teams with sponsors/clients throughout the project life cycle. Ensure all team members deliver high quality, timely service and that service delivery processes are maintained in accordance with corporate and industry best practices that meet all regulatory requirements and guidelines. Support Business Development by assisting with bid development and defense as required.

Positions: 1, global (please inquire with our talent acquisition team on specific countries of residence outside of the locations in which the role is advertised).

What We Offer

In addition, as an Alimentiv Employee, you’re also eligible for the following programs:

• Education Reimbursement program for full-time employees
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)
• Working while visiting program – up to 4 weeks per year!
• Flexible Summer Hours Program from May – September
• Employee referral incentive – we know great people know other great people, and we think that warrants recognition!
• Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment
• Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!

Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.

Our Services

• End-to-end GI clinical trial services, from protocol design through submission support
• Central medical imaging management and endoscopic reading
• Precision medicine and biomarker solutions
• Real-world evidence and clinical consulting
• Histopathology and lab services through AcelaBio

How to Apply

To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English.

Equal Opportunity and Accessibility

Alimentiv is committed to building a diverse, inclusive and respectful workplace.

Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to recruitment@alimentiv.com.

About the role:

This role will include a combination of the following:

Operational Planning & Oversight (40-50%)

• As part of the senior management team, participates in the operational planning process identifying and advocating on behalf of the functional area and the stakeholders it supports.
• Guides the departmental planning and implementation process to transform strategic plans and direction into measurable operational short- and long-term goals and targets.
• Oversee and/or participate in the project development process working with Sponsors and functional Directors to negotiate and deliver quality product(s), assessing resource and financial and safety requirements, assigning resources, overseeing trial conduct, information, and data confidentiality, and supporting project teams by assisting the troubleshooting and resolution process while ensuring all align with corporate objectives.
• Responsible to ensure sufficient project level staffing and maintain utilization targets.
• Represent project operations on cross-department planning initiatives.

Unit Leadership, Team Management and Engagement (30-40%)

• Serve as a role model, motivator, and mentor to members of the Clinical Project Operations team ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to managers and/or leaders in the areas of work allocation, resource planning, staff allocation, training and development, employee engagement, team development and performance management (staff evaluation, performance improvement and lost time management).
• Acts as senior representative of project operations team at client meetings.
• Represent project operations at business development meetings including but not limited to bid defenses, general capabilities, and scientific conferences.
• Attend and present at investigator meetings as needed.

Product Service/Excellence (10-15%)

• Works in collaboration with leadership team to achieve excellence in project services, evaluating and implementing recommendations to minimize organizational risk, meet all regulatory and/or industry standards, while creating and promoting programs that support the Organization's growth as a world class provider of clinical research and research services.

Budget Planning & Financial Risk Management (10-15%)

• Working in conjunction with members of the senior leadership team to plan, manage, advocate and report on behalf of the department during the budget and annual operational review processes.
• Maintain knowledge of financial and regulatory risks and requirements related to department service delivery and direct the development of methodologies to review, monitor, and manage risks and requirements.
• Work in conjunction 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 ensuring realization of project costs are achieved in line with work performed.

What we're looking for

Job Experience & Education Requirements:

• Undergraduate university degree (Bachelor or Honors Bachelor) + minimum of 10 years related experience and training/continuous ongoing development OR College diploma/degree and a minimum of 15 years related experience.

Additional:

• Deep experience in CRO industry with full-service project management leadership, coaching and leading a team with an excellence mindset.
• Phase II experience prerequisite, Phase III highly desirable
• Experience in gastrointestinal (GI) clinical trial project management highly desirable
• Financial Resource Management: significant financial responsibility (extensive participation in budget setting, autonomous expenditure and/or revenue generation decisions limited by company policy or financial processing, reconciliation and reporting.

Alimentiv is aware of a continued increase in phishing scams, which use various methods of attack via email, text, voice and social media, including individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process.

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