Associate Director, Start Up (Poland)

Description

The Associate Director, Start-Up is responsible for activities related to site selection, site budget and contracting, and other tasks related to the activation of clinical trial sites. The position requires the incumbent to contribute subject matter knowledge to support strategic expansions, process improvements, and decision making within the organization. The ADSUP will possess competencies to manage internal and external stakeholders’ expectations, develop and maintain strong relationships, and drive quality and consistency in start-up related activities at Indero.

The Associate Director provides leadership and oversight of the Site Selection and Contracting functional teams, ensuring operational excellence within these functions while supporting the delivery of key milestones. The incumbent will drive the development and improvement of processes, procedures, and guidelines to meet department and organizational goals.

The ADSUP has line management responsibility for functional area staff in line with company policies and applicable regulations. Responsibilities include overseeing the training of new employees, participation in hiring activities, performance management, guiding professional development, addressing employee relation concerns and escalating issues, as necessary. 

• Provide day-to-day leadership and guidance to site selection, site budget and contracting teams, and other functions aligned with study start-up, to ensure operational efficiency and alignment with study timelines and financial goals.
• Ensure teams are equipped with the necessary resources, training, and support to perform effectively, maintaining high-quality, compliant deliverables.
• Oversee hiring, onboarding, and performance management of team members, including conducting performance reviews and supporting professional development.
• In partnership with the Sr Director, participate in forecasting resource and budget needs for the department, ensuring alignment with project demands and company objectives.
• Drive department deliverables, setting priorities to keep site selection and contracting activities on track.
• Develop and maintain relationships with key clinical research sites to support accelerated start-up strategies and repeatable collaborations.
• Support proposal development by providing recommendations on site feasibility, selection, and activation timelines.
• Serve as an escalation point for clients and project teams facing start-up challenges, ensuring timely resolution and escalating to senior leadership when necessary.
• In partnership with Sr Director, oversee the maintenance and optimization of the investigator database to support efficient site identification and selection.
• Monitor key performance indicators (KPIs) for site selection, contracting, and activation, ensuring teams meet performance and quality targets.
• Collaborate with Clinical Operations and Project Management to address site performance issues, ensuring site quality concerns are escalated and managed appropriately.
• Identifies improvements and efficiencies to site activation processes and shares lessons learned broadly with key stakeholders.
• Contribute to SOP updates and process development to ensure best practices are maintained and consistently applied across site start-up operations. Including the capture and share lessons learned to improve site activation.
• Collaborates with Senior Director, Project Management to establishes and maintain a strategic vision and long-range operational plan.
• Ensures consistency and best practices are followed on all processes, protocols, and clinical systems, such as within the Clinical Trial Management System (CTMS) and electronic Trial Master File Ensures proper training is implemented to demonstrate CFR, GCP/ICH compliance.
• May perform other tasks in order to fulfill project requirements, as needed.

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements

• B.Sc. in a relevant field of study.
• Bilingual (English and French or Polish or German or Spanish) with excellent written English skills.
• 8 to 10 years’ experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in staff management and in site selection and study start-up activities and/or has worked closely with sites or worked in a site environment.
• Good knowledge of European regulations/guidelines.
• Excellent presentation, negotiation, documentation, and leadership skills, as well as strong team-orientation and interpersonal skills.
• Customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations.
• Excellent knowledge of Microsoft Office suite (Word, Excel, Power Point).
• Experience of dermatological clinical research is a definite asset.
• Quick learner, good adaptability and versatile.
• Ability to work in a team environment and establish good relationships with colleagues, sponsors, and sites.
• Organized, able to juggle competing priorities, and work in a fast pace and evolving environment
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

• Permanent full-time position
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• Ongoing learning and development  

Work location

This position is opened to candidates across Poland (home-based position).

Recruitment process: what to expect

• As part of the recruitment process for this position you will meet various team members at Indero
• The first interview will be conducted by phone (20 minutes) and the second via video conference (1 hour)
• The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Poland.