Senior Clinical Project Manager (Remote)
, , Spain
Senior Clinical Project Manager (Remote) Senior Clinical Project Manager | CliniRx | Spain
Role Summary:
CliniRx is seeking an experienced, independent and driven Clinical TrialProject Manager to successfully manage and deliver assigned clinical...
Role Summary:CliniRx is seeking an experienced, independent and driven Clinical TrialProject Manager to successfully manage and deliver assigned clinicalstudies within timelines and budgets in compliance with Good ClinicalPractices, and all Global, National and Local Regulations. Candidate willbe responsible for the overall planning, coordination, implementation, andexecution of end-to-end clinical trial from protocol development throughstudy conduct and close out. Reporting to Project Director, the ClinicalTrial Project Manager will also serve as a mentor to Associate ProjectManagers, Team Leads and Clinical Research Associates.Responsibilities:Be responsible for project planning, implementation, control, andevaluation for multiple studies with limited supervision.Develops study timeline in consultation and collaboration with thecross functional team.Coordinates and manages clinical study projects activities and team ina manner that ensures all study timelines, quality parameters, andbudgetary requirements are met.Leads the development of global study-level documentation and the setupof the required tools and systems as per the requirements of the assignedstudies.Leads development, implementation, and supervision of global DrugSupply Plan to ensure IP availability at the right place and the right timeto support study needs.Designs the training requirements of the internal team and externalteam and vendors including, but not limited to, investigator meetings andsupervise the implementation till closure.Ensures regulations are being implemented according to ICHGCP andapplicable SOPs.Continuously monitors study quality and implement the requiredstandards in order to meet compliance requirements.Performs financial management, including review and approval of siteand vendor invoices.Oversees study supplies through their management cycle (requirementsset up till used/discarded)Responsible for the biological sample management, coordinate trialrelated materials, including clinical trial supplies.Plans, organizes and manages internal team and client specific meetingsat the prescribed timelines.Timely prepares and submits project status reports for seniormanagement and sponsorLeads as well as Coordinates the cross functional team (ClinicalOperations, Biometrics, Regulatory, Safety Medical Affairs, Finance andLegal) for the timely delivery of the contracted services according toCliniRx and sponsor standards.Manages relationships with Sites/PIs and other study-related vendorssuch as Central Labs, IVRS, Technology Partners, etc.Leads the identification, management and escalation of risks eitheralone or in collaboration with the cross-functional team.About 20% to 40% travel based on the project needsParticipates in the development, review and implementation ofdepartmental SOPs and processes.Supports in the preparation of Proposals, study Budgets and Timelinesand Scope of Work/Service Agreements.Supports the identification and set up of third party providers andpreferred partners.Qualification and Experience:Bachelor’s or Master’s degree in Life Science or ClinicalResearch AdministrationMinimum 7-10 years of project management and / or clinical operationsexperience within a global CRO, Biotech or Pharma with track record inmanaging multicenter clinical studiesWorking knowledge of current industry best practices, ICH GCPguidelines, and relevant regulations for the conduct of clinicaltrialsSound project management skills including expertise in metrics analysisand reporting methodologies in addition to proficiency in MS Project, MSExcel (pivot tables, graphing) and MS PowerPointExperience working in or developing multidisciplinary teams to set up,and conduct clinical studies, preferable in the US and the EUExperience in therapeutic areas like CNS/Neurology, Oncology,Cardiovascular and Rare Disease will be a great advantageDesired Skills: Able to lead a multicounty and multicultural team and communicateeffectively.Versatile, resource full, adaptable and entrepreneurial and‘can-do’ mind set.Be a role model for junior colleagues.Sound understanding of drug development process.Ability to manage complex situations through problem-solving, criticalthinking and navigating ambiguityExperience supporting Business Development with budgets, proposals andbid defense within CRO environment.Be able to work across boundaries. Show more Show lessTagged as: remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from home
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