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Senior Clinical Trial Manager at Worldwide Clinical Trials · ApplyPick

SUMMARY: *Responsible for oversight and leading the delivery of clinical study site management activities through the co-ordination of a team of clinical staff on particularly complex studies (such as those that have a significant global reach). Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan. Uses data metrics and project planning to monitor and secure quality of data submitted from study sites and timely completion, including appropriate reporting and follow-up for all safety events by site personnel *RESPONSIBILITIES:*_Tasks may include but are not limited to:_ Provide leadership and direction to clinical site management team members from study start through closureOversee regional CTMs and coordinates efforts across the CTM teamRepresent Site Management issues at Sponsor, Investigator and Bid defense meetings and act as main point of contact for activities through the studyContributes to the overall project plan, by formulating a global monitoring strategy for site initiation, enrollment, site management and closeout phases across a given region and assigns sites on behalf of the sponsorProvide regular input to various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed Collaborates closely with other functions including Business Development, Regulatory, Study Start up and Project Management to anticipate requirements and achieve study goals When needed, assumes dual PM/CTM roleDevelop, maintain and ensure compliance with Clinical Monitoring Plans, including budgets, study tools and Site visit reports; perform regular review of protocol deviations, Out of Scope items and oversight of action items. Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as neededParticipate in the development of and implementation of recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on targetDrive efforts to improve the quality of the site data and deliverables and address any identified needs with action plans. Review data metrics to ensure data integrity and qualityReview of data trends and trip report issues identified for re-training of sites or CRA team. Escalate issues and trends per study expectations.Oversee TMF compliance of SM documents, ensuring that QC review is on target and TMF is inspection readyAccountable for Forecasting of site visits w/CRA team to ensure staffing needs are met and any identified backlog is appropriately addressedSets performance expectations and provides mentoring and coaching to colleagues and project clinical staff when needed, working closely with Clinical Operations Managers on performance feedback; May act as a mentor for CTMPerforms Co-monitoring visits where requiredMay perform site qualification, initiation, interim monitoring, and/or close out site visits as neededIf needed, Review/finalize trip reports according to WCT SOPs, expectations and as outlined in the annotated reportSupports the study team during inspections by healthcare authorities or sponsor auditsProactively identifies and mitigates risksPerform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive*OTHER SKILLS AND ABILITIES: *Excellent oral and written communication skills in EnglishExcellent planning and organizational skills with effective time managementExcellent interpersonal skills with ability to work and influence across diverse culturesExcellent presentation skillsFlexibility to changeAbility to work logically and methodicallyAbility to lead and motivate assigned team dispersed remotely across time zonesAbility to provide experience and input into process initiatives and development relating to monitoring and site management activitiesStrong customer focus, ability to interact professionally within a sponsor contactStrong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirementsExperience and understanding of therapeutic areas sufficient enough to function as CTM as appropriateDeep understanding of standard operating proceduresProficient knowledge of Microsoft Office, eCRF, IVRS packagesProficiency with IxRS, CTMS and EDC systemsThorough understanding of clinical research principles and process *REQUIREMENTS:*Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies, a minimum experience of four years as a Senior Clinical Research Associate (or equivalent) ORTwo-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of six years as a Senior Clinical Research AssociateMinimum 2 years relevant experience as a CTM/LCRA (or equivalent) including overseeing a CTM team Travel required Valid current passport requiredDriving license requiredPromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently*Note the Clinical Trial Manager role may also be referred to as a Lead Clinical Research Associate (LCRA)* We love knowing that someone is going to have a better life because of the work we do.

Senior Clinical Trial Manager

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Senior Clinical Trial Manager

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