Early Development Oncology Lead Study Manager

2 settimane fa

Lombardia, Italia Confidenziale A tempo pieno

Le contenu du poste est libell en anglais car il ncessite de nombreuses interactions avec nos filiales linternational, l'anglais tant la langue de travail.RESPONSIBILITIESThe Senior Study Data Manager is responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensures activities are completed according to agreed standards and timelines. The Senior Study Data Manager is part of the study team; provides comprehensive data management expertise and support to team members; coordinates cross functional teams to ensure the flawless conduct of a clinical trial.The ideal candidate can be based from any of our offices across Europe. This includesAssuming Lead Data Manager (L-DM) role and autonomously acting as one of study team core member; liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management activities for assigned study, discuss timelines and provide study Data management reporting. Proposes solutions for data management issues that arise during the conduct of a study, and monitor until resolutionAssuming the planification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as plannedLeading and coordinating internal DM delivery team (Database Developers, Data Management Programmers and Data Management Specialists) assigned on the study; working as a mentor for new Data Managers and accountable for the quality of data management deliverablesAccountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements. Assures that data management standards are followed. Manages study document archiving in eTMF according to eTMF guidance. Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management functionDefining and implementing the study data cleaning and validation strategy integrating risk based approachInvolved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of studyCoordinating, in collaboration with vendor external data activities:
load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.Participating or leading the implementation of department initiatives. Develops, implements and oversees processes and coordinatesactivities in conjunction with the internal team and DM TA Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures and standardsManaging service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-timePROFILEKnowledge And SkillsStrong project management skills. Anticipates problems, issues, and delays, and proactively works to minimize the impact. Learns quickly when facing new problems. Uses rigorous, objective logic and methods to solve difficult problems with effective solutions. Able to identify risks and propose mitigation plansStrong leadership behaviors; manages effectively with study team and departmental associates. Establishes rapport and collaborates inside and outside the company. Demonstrates flexibility through effective negotiationsSolid clinical trial development process. Solid understanding of Data Management scope and objectivesStrong skills to propose and support changes. Proposes and follow-up new data standards, new data management processesUnderstanding of relevant regulatory guidelines, GCP and industry standards and practices regarding data managementSolid Clinical Data Management System experience (RAVE is highly preferred) and understanding of database/programming concepts. Expertise in the usage of Data Management applications and database/file structures. Understands the rationale or is able to identify discrepancies by using query languages, such as SQL. Able to acquire and apply new technical skillsFollows through with all tasks and ensures high quality results. Set clear assignments as well as clear objectives and measures. Monitor process, progress and results. Consistently meets deadlines according to accepted levels of quality. Pays attention to detailsAutonomously works as Lead DM role with mínimal supervision and be capable of participating in transversal activities. Good team playerVendor management experience and good client facing skills are preferredGood interpersonal and communication skillsStrong English skills (both verbal and written)Proficiency in Microsoft Office Suite (intermediate level)Formal Education And Experience RequiredBachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences) and 5+ years of experience in clinical data management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in data management is required

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