Remote Clinical Trial Manager
Company : Actalent
Country: United States
Location : San Francisco, California
Post: Sun, 19 Sep 2021 05:16:11 GMT
Expires: Tue, 19 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
The Clinical Trial Manager (CTM) provides trial oversight of investigational sites, CROs and vendors (including both U.S. and Ex-U.S. regions). This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans. The CTM will also be responsible for monitoring all phases of clinical studies, as needed. This position will also provide input, support and maintenance of department clinical projects and infrastructure. The CTM reports to the Director of Clinical Operations.RESPONSIBILITIES * Vendor (e.g., CRO, Biometrics, IRT, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives and goals covering multiple regions. * Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department. * Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents for global regions (e.g., EU, APAC, China). * Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial. * Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. * Participates & provides input on study site selection activities. * Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure. * Performs remote and on-site monitoring & oversight activities using various tools to ensure: * Data generated at sites is complete, accurate and unbiased * Subjects right, safety and well-being are protected * May conduct site visits, including but not limited to, site selection, site initiation, interim monitoring, close-out, CRA oversight, and co-monitoring. Records in support of these monitoring visits must be timely, clear, comprehensive and accurate. * Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight. * Collects, reviews, and monitors required regulatory/operational documentation for study start-up, study maintenance and study close-out. * Supports clinical document control activities and associated study staff to ensure the content and management of the electronic/paper Trial Master File (eTMF/TMF) is current and inspection-ready. * Perform periodic reviews of the eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines. * Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. * Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined process as appropriate in collaboration with clinical operations management. * Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. * Tracks and coordinates trial related material availability, including clinical trial supplies and laboratory samples * Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. * Supports financial management of the study which includes review and approval of site and vendor invoices. * Supports risk Management initiatives * Supports audit/inspection activities as needed. * Maintain clinical trial registry entry/updates, as required. * Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements. MINIMUM QUALIFICATIONS * BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered. * 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international. * 3-5 years study oversight as an in-house CTM (e.g., CRO/vendor oversight) * Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out. * Travel up to 30% with overnight stays. * Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. * Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines. * Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. * Demonstrated ability to mentor/lead. * Hands on knowledge of Good Documentation Practices. * Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas. * Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. * Ability to understand and analyze data/metrics and act appropriately. * Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills. * High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. * Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships. * Works with high quality and compliance mindset. #LI-RK1 ABOUT ACTALENT: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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