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 described accountabilities may or may not apply.Daily management of trialsPOC for sponsor, sites, and CRAsStudy tracking and monitoring; trip report reviewProject oversight and leadership for clinical deliverablesLeads and manages the start-up and clinical teamsPlans and leads execution of day-to-day activities for monitoring of a clinical studyCommunicates consistently with the clinical team, providing project objectives, expectations, and status updates; works with the team to set prioritiesTakes initiative to make things happen and leads/supports relevant staff (including Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL), and In-House Clinical Research Associate (IHCRA)) to ensure successful activation of trial sites according to time, quality/scope, and budget parametersMotivates the clinical teamEnsures effective communication plans and escalation plans are in place for the clinical teamWorks with the Project Manager (PM) to facilitate cross-functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issuesMonitors the quality of clinical deliverables and addresses quality issues with the appropriate team memberRegulatory affairs and study updatesOversees GRAL, LRAL, and IHCRA to ensure all non-safety periodic updates, progress reports, renewals, 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 trialQuality metrics and continuous improvementIdentifies metrics and trends across team members, countries, and regions, using the information to promote improvement in quality and consistency of executionCollaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans; responds completely and accurately to audit reportsProvides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to the internal clinical review team/QA and then SponsorCompliance planning and Trial Master FileOrganizes project-specific compliance plans for key processes, tools, and systemsReviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are met and comply with applicable local regulatory requirements and ICH guidelinesProject financeProvides time entry guidelines to relevant study team members in adherence with project scope and budget; monitors burn rates and escalates issues with potential solutions to the Project Manager (PM)Forecasts units and hours and generic resources for start-up and monitoring activities; determines worked units and hours; analyzes forecasted and worked activities to ensure adherence to contract and budgetEnsures forecasted units are achieved as planned and within the budgeted FTEIdentifies out-of-scope tasks from the clinical team and escalates as required; ensures no out-of-scope tasks are conducted without required evidence of agreement from the client or approval by the relevant PRA staffCustomer relations (internal & external)Interfaces with other Functional Leads, vendors, and client as required to ensure clinical monitoring outcomes are achievedServes as primary liaison for clinical monitoring issues, interacting with clients, vendors, and other PRA functional areas; escalates as requiredParticipates in client meetings and assists with presentations as requiredContributes to business development activitiesQualificationsEducationBachelor’s degree in a health-related field from an accredited institution; or a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.Experience required2+ years of clinical research project management experience required.
