Project Director - Clinical Study Management

Alimentiv; North Carolina; Vor Ort; USD 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Education Reimbursement

Cell Phone and Remote Work Allowance

Office setup allowance

Working while visiting program

Flexible Summer Hours Program

Employee referral incentive

Alimentiv Trust benefits

Mentorship program

Zusammenfassung

Alimentiv is seeking an experienced clinical research professional to oversee the successful execution and delivery of clinical projects within an assigned region. This role serves as a key point of contact for sponsors, providing project oversight to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory requirements.

The successful candidate will collaborate with Clinical Project Managers, cross-functional teams, and external vendors to support

Qualifikationen

• Minimum of 7 years of relevant clinical research experience.
• Three-year advanced college diploma or degree in Health Sciences, Clinical Research, or related field.
• Strong understanding of clinical project planning, execution, oversight, and regulatory requirements.
• Proven ability to establish and maintain collaborative relationships with sponsors and cross-functional teams.
• Excellent verbal and written communication skills.
• Strong organizational skills and attention to detail.
• Leadership and team management capabilities.
• Commitment to continuous learning and process improvement.

Aufgaben

• Serve as the primary regional representative for clinical projects and ensure delivery aligned with sponsor expectations, timelines, budgets, and quality standards.
• Establish and maintain sponsor relationships and ensure effective communication and timely issue resolution.
• Oversee project planning, implementation, and execution with Clinical Project Managers and cross-functional teams.
• Review and approve project scope, budgets, timelines, performance metrics, resource requirements and training plans.
• Monitor progress, risks and performance indicators; guide CPMs to maintain quality.
• Ensure compliance with SOPs, regulatory requirements and corporate guidelines.
• Oversee forecasting, resource allocation, and staffing for current and upcoming projects.
• Monitor vendor performance to meet sponsor expectations and project requirements.
• Support recruitment, performance evaluations, training, and department budgeting.

Kenntnisse

Clinical project management

Sponsorship relationships

Verbal and written communication

Cross-functional collaboration

Leadership

Regulatory compliance

Problem solving

Ausbildung

Health Sciences degree

Clinical Research degree

Three-year diploma

Jobbeschreibung

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!

Job Overview

We are seeking an experienced clinical research professional to oversee the successful execution and delivery of clinical projects within an assigned region. This role serves as a key point of contact for sponsors, providing project oversight and ensuring clinical studies are delivered on time, within budget, and in accordance with quality and regulatory requirements.

The successful candidate will work closely with Clinical Project Managers (CPMs), cross-functional teams, and external vendors to support project planning, resource management, and operational performance. This position also contributes to business development initiatives, team development, and continuous process improvement to ensure consistent, high-quality project delivery.

Key Responsibilities

• Serve as the primary regional representative for clinical projects, ensuring successful execution and delivery in alignment with sponsor expectations, timelines, budgets, and quality standards.
• Establish and maintain strong sponsor relationships, ensuring effective communication, timely resolution of issues, and alignment on project expectations and deliverables.
• Oversee clinical project planning, implementation, and execution in collaboration with Clinical Project Managers and cross-functional teams.
• Review and approve project scope, budgets, timelines, performance metrics, resource requirements, and training plans to ensure successful project delivery.
• Monitor project progress, critical paths, risks, and performance indicators, providing guidance to Clinical Project Managers to address challenges and maintain project quality.
• Ensure clinical projects comply with Standard Operating Procedures (SOPs), regulatory requirements, corporate guidelines, and industry best practices.
• Oversee project forecasting, resource allocation, and staffing requirements to ensure appropriate support for current and upcoming clinical projects.
• Monitor internal team and third-party vendor performance, ensuring services consistently meet sponsor expectations and project requirements.
• Support team management activities, including recruitment, performance evaluations, employee training, development, and departmental budget planning.
• Contribute to business development activities, including proposal development, Requests for Proposals (RFPs), bid defenses, and prospective client engagement.

Skills & Qualifications

• Minimum of 7 years of relevant professional experience in clinical research or a related field, supported by ongoing professional training and development.
• A three‑year advanced college diploma or degree in a relevant discipline, preferably Health Sciences, Clinical Research, or a related field.
• Strong understanding of clinical project planning, execution, oversight, and delivery within established quality and regulatory requirements.
• Demonstrated ability to establish and maintain collaborative relationships with sponsors, internal stakeholders, and cross‑functional project teams.
• Excellent verbal and written communication skills, with the ability to communicate project updates, risks, and expectations clearly and effectively.
• Strong organizational skills and attention to detail, with the ability to monitor multiple project priorities, timelines, and deliverables.
• Ability to assess project requirements, identify potential risks, resolve issues, and support effective decision‑making to achieve positive outcomes.
• Strong leadership and team management capabilities, with the ability to foster teamwork, support employee development, and promote accountability.
• Self‑motivated and results‑oriented, with a demonstrated commitment to delivering high‑quality services and achieving project objectives.
• Commitment to continuous learning, professional development, and improving operational processes and team performance.

What We Offer

• 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

Equal Opportunity and Accessibility

Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law.

Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to [e-mail].

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Please note that the salary range may vary depending on the country in which the position is based.

Performance‑Based Incentive Program

At Alimentiv, we recognize and reward great performance. In addition to a competitive salary, eligible employees can participate in our Short‑Term Incentive Plan (STIP), which offers the opportunity to earn additional compensation based on individual contributions, team achievements, and company performance.