Clinical Project Manager
6 giorni fa
The Clinical Project Manager is responsible for the management of clinical projects and studies by collaborating with Clinical Affairs in the implementation of various team and company objectives for the execution of clinical studies.The role, in close collaboration with the Project Leader, is accountable for achieving successful deliverables, working together with the clinical team while meeting company and regulatory requirements according to time, quality, scope and within budget.The position is office-based.Responsibilities Proactively manage project-level operations, including but not limited to management of trial timeline, budget, resources with consideration of quality standards and risk mitigation Provide project leadership and project support for both U.S. and International Clinical Trials consistent with applicable laws, regulations, guidelines and policies.Ensure conformance with GCP, trial protocols and trial safety reporting requirements Lead projects that support division and company objectives Adhere to study execution strategy in order to meet business objectives Implement immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner Ensures protocol adherence at all clinical centers in order to maintain a high level of compliance, data integrity and the highest possible percentage of patient follow-up Support IRB/EC/CA submissions and renewals Contribute to the strategic development of FDA submissions (510K), Premarket Approval, IDE, De Novo and Medical Device Reporting Oversee site contracts, payment schedules and payments Provide efficient and effective updates on trial progress to the Medical Director as requested Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets.Ensure effective project plans are in place and operational for each trial.Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.Attend trial progress meetings, ensure meeting minutes are completed, distributed to team members and filed in the TMF in a timely manner.Review and approve site visit reports, ensure tracking, follow-up and resolution of site-specific issues have been completed in a timely manner.Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.Qualifications Must have relevant experience executing clinical programs in medical devices, particularly cardiovascular interventional cardiology or ICU-based clinical trials.Solid understanding of reimbursement Education: Bachelor's degree in Lifescience, Master in a health-related field is a plus Languages: proficiency in oral and written English and Italian (third language would be appreciated) Experience: minimum of five years of clinical research experience in Project Management, Data Management or Clinical Monitoring.Previous experience in a pharmaceutical, CRO or medical device company required Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485 Personal skills Ability to communicate, problem solve and work effectively in an international team Innovative and self-motivated Good organization skills and ability to prioritize goals and responsibilities Ability to negotiate and communicate with clients in a professional manner Proficient computer skills with the ability to understand and assess technology alternatives and implication for current processes Ability to be productive and successful in a dynamic work environment
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Senior Clinical Project Manager
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Lazio, Italia Confidenziale A tempo pienoOur client is an international company of skilled professionals from the medical device and pharmaceutical industry, from clinical research and the regulatory field. Our client is a dynamic and proactive group that offers the medical device and pharmaceutical industry regulatory support, digital solutions and full-service CRO assistance focused on...
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Sponsor Dedicated Sr Clinical Project Manager
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Lazio, Italia Confidenziale A tempo pienoSponsor dedicated Sr Clinical Project Manager - Home based ITA Experience as Clinical PM required; experience in vaccines field would be considered a plus. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to acrate customer success. We lead with a product development mindset, seamlessly connecting our...
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Clinical Trial Manager
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Lazio, Italia Confidenziale A tempo pienoJob Summary Confidenziale is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in Italy, particularly in our Milan office. Clinical Trial Managers with expertise in Neuroscience and CNS are welcome to continue to work in their area of expertise or...
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Clinical Trial Manager
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Lazio, Italia Confidenziale A tempo pienoJob Summary Confidenziale is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in Italy, particularly in our Milan office. Clinical Trial Managers with expertise in Cardiovascular|Endocrine|Metabolic are welcome to continue to work in their area of...
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Clinical Innovation
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Lazio, Italia Novo Nordisk AS A tempo pienoPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Select how often (in days) to receive an alert: Clinical Innovation & Implementation Manager Category: Clinical Development Location: Roma, Lazio, IT Are you an experienced professional who is passionate to drive innovation in clinical...
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Clinical Innovation
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Lazio, Italia Novo Nordisk AS A tempo pienoPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Select how often (in days) to receive an alert: Clinical Innovation & Implementation Manager Category: Clinical Development Location: Roma, Lazio, IT Are you an experienced professional who is passionate to drive innovation in clinical...
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Clinical Research Associate
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Lazio, Italia Meditrial Europe Ltd. A tempo pienoMeditrial is looking for a certified clinical research associate (CRA) experienced in clinical trial monitoring, EDC systems, Digital Health solutions and Data analysis.The resource will participate in the preparation and execution of Phase I-IV clinical trials, oversee the progress of clinical investigations by conducting site evaluation, initiation, and...
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Clinical Data Manager – Italy
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Lazio, Italia Jr Italy A tempo pienocol-wideJob Description:Job OverviewCollaborate with the project team on the overall data management strategy for the program or project to ensure overall quality and efficiencyDevelop, generate and analyze project progress and/or metrics reports and report findings and corrective actions as requiredLead the development of CRF specifications, validate them,...
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Clinical Research Scientist
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Lazio, Italia Confidenziale A tempo pienoNMS Group is the largest company in Italy, committed in innovation and research and development in oncology. Nerviano Medical Sciences srl, representing the innovative heart of the group, is looking for a CLINICAL RESEARCH SCIENTIST Main responsibilities The Clinical Research Scientist, reporting to the Global Clinical Lead, will contribute to the...
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Clinical Trial Manager
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Lazio, Italia Icon Plc A tempo pienoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...
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Sr. Clinical Research Associate
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Lazio, Italia Allucent A tempo pienoDescriptionAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will...
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Manager, Clinical Data Programming
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Lazio, Italia Iqvia A tempo pienoJob Description: Provide line and functional management of Data Management technical experts, with a team size of around 15-20 people.Manage and prioritize resource assignments, as well as workload management across Technical Design and SAS Programming teams ensuring project milestones are met according to agreed timelines with high quality. Monitor and...
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Clinical Research Associate
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Lazio, Italia Novo Nordisk AS A tempo pienoAre you passionate about managing clinical trial sites and ensuring adherence to regulatory requirements?Do you want to contribute to making Novo Nordisk the preferred partner in clinical trials?If so, we have an exciting opportunity for you to join our team as a Clinical Research Associate (CRA).Apply today for a life-changing career.The Position The CRA is...
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Clinical Research Associate
6 giorni fa
Lazio, Italia Novo Nordisk A tempo pienoAre you passionate about managing clinical trial sites and ensuring adherence to regulatory requirements?Do you want to contribute to making Novo Nordisk the preferred partner in clinical trials?If so, we have an exciting opportunity for you to join our team as a Clinical Research Associate (CRA).Apply today for a life-changing career.The Position The CRA is...
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Regional Clinical Trial Management Associate
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Lazio, Italia Jr Italy A tempo pienocol-wideJob Description:Regional Clinical Trial Management Associate page is loaded Regional Clinical Trial Management Associate Apply locations Italy Remote time type Full time posted on Posted Yesterday job requisition id R22857 BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When...
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Clinical Specialist
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Lazio, Italia Masimo Corporation A tempo pienoCentral Italy Job Summary: The Clinical Specialist is an entry level role responsible for supporting Masimo Products and maintaining customer relationships with a variety of clinicians and other key stakeholders. Duties & Responsibilities: You will be seen as an expert in pulse oximetry and pulse CO-Oximetry as well as an authority on the clinical impact of...
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Clinical Specialist
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Lazio, Italia Masimo Corporation A tempo pienoCentral Italy Job Summary: The Clinical Specialist is an entry level role responsible for supporting Masimo Products and maintaining customer relationships with a variety of clinicians and other key stakeholders. Duties & Responsibilities: You will be seen as an expert in pulse oximetry and pulse CO-Oximetry as well as an authority on the clinical impact of...
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Clinical Start-Up Specialist
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Lazio, Italia Novo Nordisk AS A tempo pienoAre you an experienced clinical research professional interested in the start-up and regulatory aspects?Do you need to have things in order, and attention to detail is one of your qualities?If you are ready to make a difference in our clinical department, you might be our new Clinical Start-Up Specialist.Apply today and drive the change with us at Novo...
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Clinical Research Physician
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Project Manager
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Lazio, Italia Thermo Fisher Scientific A tempo pienoLocation/Division Specific Information Ferentino, Italy PURPOSE OF THE POSITION/RESPONSIBILITY: Be responsible and accountable for PDS projects in respect to PDS Project Management Supervisor. Meet customer and business expectations by bringing multiple projects to completion according to agreed timelines and financial planning. ASSIGNMENTS,...
