ph3Description /h3 pThe project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline) /p h3This role will be perfect for you if: /h3 ul liYou want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects /li liYou are looking to position yourself in an environment where you can grow your career alongside the company /li /ul h3IMPACT AND RESPONSIBILITIES /h3 h3Client interactions /h3 ul liServe as primary contact for the Sponsor /li liProvide efficient and timely updates on trial progress /li liLead client calls effectively /li /ul h3Project planning /h3 ul liOversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report. /li liParticipate in the planning and conduct of the Investigator’s Meeting. /li liEnsure 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 liLead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.



/li liCollaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study. /li liPartner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met. /li /ul h3Quality and risk management /h3 ul liEnsure assigned studies are “audit ready” at all times. /li liMonitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise. /li liManage risk and control measures to assure project quality. /li liAnalyze discrepancies between planned and vigente results. h3Project team leadership /h3 ul liLead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants. /li liEnsure all team members have adequate training on the project. /li liWork closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs. /li liDefine and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study. /li /ul h3Requirements /h3 h3Education /h3 ul liB.Sc.



in a related field of study to clinical research /li /ul h3Experience /h3 ul liAt least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management /li liExperience managing dermatology and/or rheumatology trials /li liExperience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD. /li liExperience managing dermatology trials an asset /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 /ul h3Our company /h3 h3The work environment /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 pIn this position, you will be eligible for the following perks: /p 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 pOriginally posted on Himalayas /p /li /ul /p #J-18808-Ljbffr

📌 Project Manager II (Spain) (España)
🏢 Visa Hunt
📍 España