06 ago
|
Indero (formerly Innovaderm)
|
Madrid
06 ago
Indero (formerly Innovaderm)
Madrid
ppProjects Managers with experience in Dermatology and/or Rheumatology are crucial to the success of Clinical Trials managed by Indero. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected. /p pGreat project managers go further than creating project plans and following up on tasks. They show leadership to help project teams focus on objectives and deliver results. /p h3We are looking for someone who: /h3 ul liHas at least 7 years of Global clinical project management experience (including but not limited to European regions), including management of all project’s phases from start-up to closure, management of all functional services, vendor management. /li liWishes to work for a mid-sized CRO that works on significant multisite trials, including Integral Phase III projects. /li liIs looking to position themselves in an environment where they can grow their career alongside a growing 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 participate 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 /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 actual results. /li liReview and approve responses to quality assurance audits.
/li /ul h3Project budget and timelines /h3 ul liControl the project budget, with particular attention to internal hours allocated to all activities. /li liIdentify out of scope activities for change orders. /li liProactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project. /li liCommunicate effectively with study team members, functional departments, and senior management. /li liManage and report on recruitment status and highlight initiatives needed to meet recruitment timelines. /li /ul 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 /ul h3Requirements /h3 h3IDEAL PROFILE /h3 h3Education /h3 ul liB.Sc. in a related field of study to clinical research /li liPMP or PRINCE2 certification is an asset /li /ul h3Experience /h3 ul liAt least 10 years industry experience including a minimum of 3 years in a CRO /li liAt least 7 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) /li liExperience leading multi-centered,
multinational phase III clinical trials including project budget financial tracking and forecasting /li liExperience in one or more of the following considered an asset: study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management /li liTherapeutic experience managing dermatology, onco-dermatology, rheumatoid arthritis or oncology trials an asset /li /ul h3Knowledge And Skills /h3 ul liExcellent knowledge of GCP and ICH standards, local country regulations /li liExcellent knowledge of Microsoft Office suite /li liFluency in English with excellent oral and written skills, required /li liBilingualism (English and local language) is an asset /li liAbility to work in a team environment and establish good relationships with colleagues and sponsors /li liGood problem-solving abilities /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 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 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. /p pIndero 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 Spain. /p /p #J-18808-Ljbffr
📌 Senior Project Manager - Dermatology/Rheumatology (Spain) (Madrid)
🏢 Indero (formerly Innovaderm)
📍 Madrid