ppIndero only accepts applicants who can legally work in Spain. /p pThe Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The Project Manager I must ensure compliance with the study budget, project scope and timelines in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study‑specific requirements. These tasks are done under close supervision by Senior Project Manager/Program Director and/or Associate Director, Project Management. /p h3This role will be perfect for you if: /h3 ul liWe can count on you to deliver results while using a disciplined approach to project management /li liYou are looking for the next career step to prepare you to become a project manager. /li liYou are knowledgeable about clinical research projects and looking to continue learning. /li liWorking in an organization that is driven by science and innovation and completing meaningful work is important to you. /li /ul h3Responsibilities /h3 ul liMay serve as primary contact for the Sponsor, vendors and internal team throughout the study. /li liCoordinates tasks and deadlines between the different departments involved in the project. /li liOversees project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities amongst team members /li liInteracts with vendor management to ensure vendor supplies and services are coordinated for with site activation timelines /li liEscalates to project manager II when site activation timelines are at risk or cannot be maintained. /li liAssists with managing the needs and expectations of the Sponsor and other internal and external project stakeholders. /li liAssists with ensuring all team members are adequately trained on the project. /li liMay plan the activities and resources (e.g., internal and external resources, equipment, etc.) required for the project. /li liManages the quality of assigned work and deliverables /li liAssists with providing project status updates to external and internal stakeholders /liliEnsures assigned tasks are completed in compliance with the study budget, project scope and timelines and in accordance with applicable SOPs, GCP, regulatory and study‑specific requirements. /li liReconciles study trackers /li liAssists with analyzing discrepancies between planned and presente results and participates in the development and implementation of corrective actions to be taken as needed. /li liAssists with enforcing effective change control and risk management throughout the project. /li liReviews and may assist in the drafting of project operational plans, processes, and manuals as applicable (e.g., project management plan, monitoring plan, etc.). /li liAssists with ensuring that study‑specific documents and project deliverables (e.g., protocol, informed consent form,



electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) meet applicable country requirements. /li liOversee activities related to sites selection (feasibility questionnaires, sites selection, planning of site qualification visits) /li liMonitors patient recruitment, subject status, and follows up with sites on recruitment strategy plan. /li liParticipates in the planning and conduct of Investigator’s Meeting. /li liIn collaboration with the Regulatory Affairs group, may oversee activities related to central ethics and regulatory submissions. /li liEnsures collection of required essential documents from the sites prior to study initiation and maintains currency of site level documentation throughout the study. /li liMay assist the project manager II with quality reviews and or audits of the Trial Master File (TMF) to ensure inspection readiness. /li liMay support clinical monitoring activities, such as CRA training, visit report review, site letters, and escalated site issues /li liMay track site qualification, initiation, routine and close‑out visits, project‑specific training, monitoring visit reports and follow‑up letters, compliance with monitoring plan, escalation of site‑related issues. /li liMaintains the project specific training matrix and confirms project team members are fully trained per the study matrix before performing study tasks /li liSupports the sites and ensures that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.). /li liIn collaboration with the Data Management group, may ensure that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines until database lock. /li liMay provide technical, therapeutic and project management expertise in training and process improvement efforts for the department. /li /ul h3Requirements /h3 h3IDEAL PROFILE /h3 h3Education /h3 ul liB.Sc. in a related field of study to clinical research /li /ul h3Experience /h3 ul liAt least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry /li liAt least 2 years experience coordinating activities related clinical trial management /li /ul h3Knowledge And Skills /h3 ul liExcellent knowledge of GCP and ICH standards,



FDA and Canadian regulations /li liExcellent knowledge of Microsoft Office suite /li liExcellent oral and written skills in English, French is an asset /li liExcellent communication skills /li liAbility to work in a team environment and establish good relationships with colleagues and sponsors /li liGood problem‑solving abilities /li liGood organizational skills /li liStrong ability to carry out different projects and work under pressure while meeting timelines /li liExperience managing small to medium projects using a disciplined approach to project management /li liCore Project Management competencies /li liDemonstrated ability to establish and deliver resource‑based project plans /li liExcellent people management skills; experience working with and managing teams in a matrix environment /li /ul h3Our company /h3 pAt 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. /p h3Perks /h3 ul liFlexible work schedule /li liPermanent full‑time position /li liCompany benefits package /li liOngoing learning and development /li /ul h3About Indero /h3 pIndero is a 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. /p pbIndero 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. /b /p pbIndero only accepts applicants who can legally work in Spain. /b /p h3Profil recherché /h3 h3Éducation /h3 ul liB.Sc. dans une discipline pertinente à la recherche clinique; /li /ul h3Expérience /h3 ul liMinimum de 3 années d'expérience dans un rôle similaire, incluant des activités liées à la gestion d’études cliniques dans l’industrie pharmaceutique, biotechnologique et/ou CRO; /li /ul h3Aptitudes et connaissances /h3 ul liExcellente connaissance des bonnes pratiques cliniques, des normes ICH, ainsi que de la réglementation de la FDA et de Santé Canada; /li liExcellente connaissance de la suite Microsoft Office; /li liExcellentes habiletés de communication; /li liExcellentes capacités orales et écrites en Anglais, le français représente un atout; /li liHabileté à travailler en équipe et à établir de bonnes relations avec ses collègues et clients; /li liBonnes aptitudes à la résolution de problème; /li liBonne capacité d’organisation /li liForte capacité à mener différents projets à bien et à travailler sous pression en respectant des échéanciers. /li /ul /p #J-18808-Ljbffr

📌 Project Manager (Spain) (Madrid)
🏢 Indero (formerly Innovaderm)
📍 Madrid