Clinical Trial Manager (6 month contract)

Job Title: Clinical Trial Manager (6 month contract)

Job Number: 84847

Location: Remote, US

Job Description

The Clinical Trial Manager (CTM) will support clinical studies by assisting the Clinical Program Manager or Study Management Team Lead in ensuring efficient trial delivery within a matrix environment. Key responsibilities include ensuring compliance with regulations, guidelines, and procedures, and supporting project timelines, contracts, budgets, vendor management, invoicing, and monitoring visits. The role also involves overseeing milestones, deliverables, and communications with internal and external stakeholders. This position may be remote or in-house, depending on experience, and will report to a Clinical Program Director.

Responsibilities

* Manage day-to-day operational aspects of clinical trials, including vendor and site management. * Obtain and review essential documents for study/site initiation. * Maintain accurate sponsor/site correspondence and communication; prepare and present project progress reports. * Track patient enrollment, site performance, and monitoring metrics. * Ensure adherence to ICH GCP, regulations, protocols, and company SOPs/policies. * Support the development and review of clinical study plans, presentations, and study documents. * Assist with the development and design of CRFs, EDC and IXRS specifications, and user acceptance testing. * Set up central labs and study vendors; coordinate site training and initiation. * Review clinical data listings for accuracy and escalate issues as needed. * Work with data management on data cleaning activities. * Lead protocol deviation reviews and documentation. * Oversee clinical monitoring and site management to ensure compliance and track performance metrics. * Perform site visits with CRO monitors to ensure adherence to procedures and review regulatory documents. * Review monitoring trip reports and track resolution of action items. * Participate in the selection, training, and evaluation of study personnel. * Provide oversight of CROs and vendors, and assist with site oversight and issue resolution. * Assist with the set-up and review of trial master files. * Organize internal and investigator meetings, and other trial-specific meetings. * Contribute to the development and review of trial documents (protocols, informed consent forms, patient materials). * Support vendor scope development and management, including quality, budget, and timelines. * Recommend and implement improvements to enhance program management efficiency and quality. * Contribute to process and departmental improvement activities.

Required Skills

Requirements: * Bachelor’s degree, preferably in a scientific field. * Minimum of 5 years of related industry experience in the pharmaceutical industry or equivalent, including 2+ years of trial management experience; oncology experience preferred. * Core understanding of clinical trial terminology and activities. Skills/Abilities: * Thorough knowledge of ICH GCP guidelines and applicable regulations. * Understanding of clinical trial processes from start-up to closure. * Ability to prioritize tasks, work with urgency, and collaborate effectively with study teams, cross-functional team members, and external partners/vendors. * Excellent planning and organizational skills. * Self-motivated, assertive, with the ability to work independently and as part of a team. * Strong interpersonal and negotiation skills, with effective verbal and written communication (including presentation skills). * Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., EDC, IRT, CTMS, eTMF). * Willingness to travel 10-20% (domestic and international).

Application Deadline: 2024-11-04