Senior Clinical Trial Manager (CTL) - Oncology

Gaithersburg, MD
Dec 02, 2021
Dec 04, 2021
Full Time
Job Overview:Senior Clinical Trial Manager (Sr. Clinical Team Lead)United StatesWhy settle for one thing when you can have everything?Labcorp Drug Development gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks? Working at Covance"A cents € one of the largest FSP CROs"A cents € and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!Dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, we have an FSP opportunity to match your area of expertise.You will enjoy the best of both worlds"A cents € all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.Our FSP model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.Senior Clinical Trial ManagerIn this role, the selected candidate will be responsible for study oversight and delivery management (time, budget, quality) at country level from start up to close out and will be the main point of contact for internal and external stakeholders.Essential Job Duties:Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members; Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targetsDevelops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met; leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/sAssessment and set up the of vendors during study start up period (locally); Investigator Meeting participation and preparationEnsures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel; Validation of study related materials (ie protocol, ICF, patient material)Responsible for preparing country specific documents (eg global country specific amendment); Prepares materials for Site Initiation Visits; responsible for verifying and confirming with local team eTMF completeness (Country and Site level)Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.Coordination of database locks and query follow up. Ensures timelines are me; ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activitiesCoordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion; Lead study team meetings locallyReviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable); Management of Site relationships (includes CRO related issues); May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs); May perform site closure activities, including post-close out; May act as point of contact for Sites; May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.Education/Qualifications:Must have a Bachelor's Degree with at least 6 years of relevant clinical research experience.COVID-19 vaccination requiredExperience:Must be flexible and dependable with a BA, BS, or MS degree.Must be capable of handling multiple projects and have good computer skills.Must have a working knowledge of GCP/ICH guidelines good interpersonal experience and demonstrate ability to set priorities.Exhibits professionalism communicates effectively and is a good team player.

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