Clinical Trial Manager/Project Manager (US-East-Coast Remote)

ResponsibilitiesThe Clinical Trial Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The Clinical Trial Manager (CTM) leads and directs cross functional teams and understands/manages client expectations. In addition, the Clinical Trial Manager (CTM) proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted accountabilities may ormay not apply.Daily Management of a TrialsPOC for sponsor, sites and CRAs Study Tracking and Monitoring trip report review Provides Project Oversight and Leadership for Clinical Deliverables:Leads and manages the start-up and clinical teamsPlans and leads execution of the day to day activities for the monitoring of a clinical studyand communicates consistently with the clinical team providing project objectives, expectations andstatus updates. Works with the team to set prioritiesTakes the initiative to make things happen and leads and supports the relevant staff ( this mayinclude but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead(GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) toensure the successful activation of trial sites according to time, quality/scope and budgetparametersMotivates the clinical teamEnsures effective communication plans are place for the clinical team Ensures effective escalationplans are in place for the clinical teamWorks with the Project Manager (PM) to facilitate cross functional team and sponsor communicationfor proactive, study-wide problem solving regarding study progress and trial issues during thestudyMonitors the quality of clinical deliverables and addresses quality issues with the appropriateteam memberOversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports andrenewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations,ICH-GCP and any other processes or procedures governing the clinical trial.Identifies metrics and trends across team members, countries, regions and uses the information topromote improvement in quality and consistency of execution.Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans,responds completely and accurately to audit reports, provides team with project-specific audit process to ensureadequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA andthen Sponsor Organizes project specific compliance plans for key processes, tools and systemsReviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigatorobligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelinesProject FinanceProvides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget;monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked unitsand hours, analyzing forecasted and worked activities to ensure adherence to contract and budgetEnsures that forecasted units are achieved as planned and within the budgeted FTEIdentifies out-of-scope tasks from clinical team and escalates as requiredEnsures no out-scope tasks be conducted without the required evidence of agreement from the client or approvalby the relevant PRA staff.Customer Relations (Internal & External)Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes areachievedServes as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functionalareas, escalating as requiredParticipates in client meetings, assisting with presentations as requiredContributes to Business Development activitiesQualificationsEducation:Bachelors Degree in health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.Experince requried:2+ years of clinical research project management experience requiredOriginally posted on Himalayas