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(Sr.) Clinical Trial Manager- CNS/Rare Diseases (home based)

Company: ICON Clinical Research
Location: Springfield
Posted on: November 26, 2022

Job Description:

Job Title : (Sr.) Clinical Trial Manager - (CNS)Location: Remote (US)Overview:The Clinical Trial Manager is responsible for the delivery of all clinical aspects of the study. The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrolment and study start-up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors & cross-functional teams, identifies & mitigates risks that may impact clinical delivery, and provides reporting & metrics on all clinical activities. The CTM will also participate in Sponsor, Investigator and bid defense meetings.The Role:Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders. *Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments. *Responsible for driving enrolment as per contracted timelines. *Regular oversight of key clinical metrics including but not limited to: Days on Site (DOS), Monitoring Visit Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) and other quality metrics, to ensure they are met and followed-up as necessary. *Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers, as appropriate. *Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner. *Contribute to the development and maintenance of all clinical elements of cross functional project plans. Able to work on multinational studies and may take the role of a Global CTM if appropriate. *Responsible for coordinating and managing the clinical project team to ensure:o high performance and productivity (e.g. DOS for CRAs)o optimal utilizationo minimal turnovero all necessary project training is provided, documented and filed appropriately. *Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including issue escalation and resolution. Responsible for the development and maintenance of operational plans for clinical deliverables e.g. CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc. *Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary. This includes documented QC checks of in house investigator site files. *Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved. *Lead and/or actively participate in the conduct of clinical team meetings. *Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables. *Implement QC activities, ensure compliance with quality measures and monitor required quality metrics. *Maintain confidentiality of information, as appropriate. Participate in business development activities such as bid defense meetings May be required to undertake individual, finite PM tasks under supervision and with support of the Line Manager. Participate in Company/Departmental initiatives, as requested. Undertake other reasonably related duties as assigned. *Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance. *As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs. Participate in opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.You will need: 4 year degree or equivalent combination of education & experience Demonstrated ability to drive the clinical deliverables of a study Subject matter expertise in CNS, or Rare Diseases Prior monitoring experience is preferred Ability to travel up to 20% Fluent in local language - both written & verbalBenefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career -both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Keywords: ICON Clinical Research, Springfield , (Sr.) Clinical Trial Manager- CNS/Rare Diseases (home based), Healthcare , Springfield, Illinois

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