Clinical Trial Manager - Investigator Initiated Studies
PRA Health Sciences
Req #: 110617
Type: United Kingdom
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Overview: As a Clincal Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: The Trial Manager will be responsible for all operational aspects of multiple projects/programs such as Compassionate Use Programs, Investigator-Initiated (IIS) Studies, and Collaboration Studies What you will be doing: * Has operational responsibility across multiple projects/program(s) with minimal direction: Compassionate Use, Expanded Access Programs, IIS, and Collaboration studies * Accountable for financial forecasting accuracy of Medical Study Operartions for studies within span of responsibility. * Maintainance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforcaseted as necessary, and brand give back are fully assessed. * Maintains fianancial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies. * Reponsible for managing drug supply for Compassionate Use and IIS programs, as appropriate. * Manages vendors and financial tracking as required per program * Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency Qualifications: You are: * Minimum of Bachelors Degree (advanced degree preferred). * Minimum four to six years clinical trial management experience * Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.) * 5 - 7 years' experience working in area(s) of research and/or regulatory and/or a field-based function in pharmaceutical and/or biotech company (ies). * Ideally, the incumbent will have a science background with active experience in aforementioned areas, ideally in the therapeutic areas of inflammation/immunology/antibody research. * Incumbent must have track record of working well in a dynamic environment, must be self-motivated, able to work with a limited amount of supervision after the initial on-boarding period and enjoy working with different stakeholders (clinical, pre-clinical, commercial, external customers). Why 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. Our success depends on the knowledge, capabilities and quality of our people. That's 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. 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, colour, 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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