The Manager of Site Selection and Contracting (SSC) is responsible for the site selection and site contracting process in Europe, optimizing the selection of investigators for the different trials managed by Innovaderm in the region while keeping in mind the interest of investigators to ensure they are motivated and have continued interest in working repeatedly on Innovaderm studies. The Manager is responsible for the supervision of the site selection and contracting personnel in Europe (EU). Ensuring all SSC EU activities are conducted to the Sponsor’s satisfaction, in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements. 

RESPONSIBILITIES

More specifically, the Manager, Site Selection and Contracting, Europe:

• Assists with recruiting new resources based on company needs; manages onboarding process for new employees; ensures adequate training of new and existing team members; plans and assigns work; oversees the performance of direct reports and performs annual reviews; guides professional development; addresses employee relation issues; escalates issues and communicates project risks to Management, as necessary
• Leads the development of country-specific start-up guidelines for EU
• Acts as a subject matter expert in local EU regulations for study start-up activities
• Supervises/launches pre-feasibility assessments in EU, that will drive recommendation of countries and sites for new proposal requests
• Participates in proposal requests by recommending the investigators’ fee budget for proposals based on fair market value for each EU countries
• Develops and maintains positive and productive relationships with key clinical research sites in EU
• Supports and develops strategies for the expansion of the investigator database in EU
• Supports company level efforts and initiatives related to global expansion
• Seeks out regularly site interest and satisfaction in order to build a good relationship with investigator sitesSupervises/creates study-specific feasibility questionnaire templates and coordinates distribution to interested sites
• Supervises/reviews completed feasibility questionnaires from potential sites and recommends sites for qualification visits
• Supervises/coordinates CRA resources allocation required for site qualification visits
• Supervises/participates in sites selection including review of site qualification visit summaries
• Recommends/approves sites for participation in the study, in consultation with the Sponsor and the project team, as necessary
• Supervises/reviews site budget and contract negotiations
• Ensures adequate training and consistent use by the internal team members of SOPs and Tools related to sites selection activities
• Ensures project budget and timelines are met (i.e., site identification, feasibility assessment, sites selection)
• Facilitates internal collaboration between project teams, legal affairs, regulatory affairs and SSC to ensure efficient study start-up, following country-specific requirements
• Facilitates collaboration and cohesion with the North American teams and activities
• Works in collaboration with project teams to identify quality issues related to sites performance through project meetings, escalation of site communications, and quality assurance audit findings
• Identifies and maintains departmental key performance indicators (KPIs)
• Authors, reviews and updates related SOPs and Tool as necessary
• Provides assistance, as needed, with site communications in local languages
• 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.
• Employees located outside of North America are expected to have some flexibility in their working hours, to accommodate team or client meetings as needed. All efforts will be made by Innovaderm to accommodate various time zones of team members

IDEAL PROFILE 

Education

• B.Sc. or in a relevant field of study
• Excellent English written and spoken skills. Bilingual with either Polish or Spanish languages (based on the location)

Experience

• Minimum of 5 years’ experience in EU clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in site selection, study start-up activities and/or has worked closely with sites or worked in a site environment.
• Staff management experience is an asset
• Experience of dermatological clinical research is a definite asset
• Expertise and knowledge of local regulations for study start-up processes in various EU countries is required as well as knowledge of the updated European Union pharmaceutical legislation for the Clinical Trials Regulation (CTR) 

Knowledge and skills

• German written and spoken language is an asset
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
• Excellent knowledge of Microsoft Office suite (Word, Excel, Power Point)
• Quick learner, good adaptability and versatile
• Ability to work in a team environment and establish good relationships with colleagues, sponsors, and sites is critical
• Organized, able to juggle competing priorities, and work in a fast pace and evolving environment
• Flexibility, positive attitude, superior attention to detail, and critical thinking skills

OUR COMPANY

The work environment

At Innovaderm, 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. 

Work location

Note that this opening is for a home-based position in Poland or in Spain.

Regular travel, which may include overnight trips and / or international travel is required as part of this role.

Covid-19 vaccination policy: The health and safety of all is important to us. In accordance with the applicable vaccination policy, Innovaderm requires that all employees present at its offices as well as all client and vendor sites (including clinical sites) be adequately vaccinated, under reserve of exemptions related to adaptation requirements prescribed by law.

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. 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, Innovaderm continues to grow and expand in North America and Europe.

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

Innovaderm only accepts applicants who can legally work in Poland or in Spain.