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Simbec Orion Group Ltd
,
Slough, Berkshire
Principal Data Manager
Overview
Simbec-Orion Group is a full-service, boutique CRO which offers specialist expertise in oncology, rare & orphan diseases, dermatology, respiratory, neurology and infectious diseases and translational medicine. We offer our clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post marketing studies. We have expertise in all drug types, dosage forms and delivery mechanisms. Simbec-Orion Group supports its clients' development programmes with our in-house central laboratories, pharmacovigilance, data management and statistics, IMP management/pharmacy and medical management. Main Duties and Responsibilities: We are looking for a Principal Data Manager to join our Biometrics department. You will support the Data Manager Team Leads in providing oversite of clinical studies, ensuring relevant standards are maintained according to Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs) and ICH-GCP guidelines to ensure the quality of the clinical data delivered to our sponsors is of the highest standard. You will also provide technical support, training and mentoring to the Data Management team. A key part of the role is to build and maintain effective working relationships with a range of stakeholders and to assist with process improvement activities for the department. This role will also participate in internal /external audits, system validation activities and presenting at face to face meetings, which include Investigator Meetings, Kick-off Meetings and Bid Defence Meetings. Minimum Requirements: Essential: - Previous experience of data management within the Pharmaceutical industry or a Clinical Research Organisation - Experience of working on studies using EDC databases - Experience in preparing and presenting at Sponsor presentations including Kick of Meetings or Investigator Meetings - Previous experience of coaching or mentoring - Experience with supporting process improvement activities within Data Management Desirable: - Degree or equivalent in any science subject - Experience in preparing and presenting at bid defence meetings, including preparatory and follow up meetings - Experience in identifying and tracking Out of Scope Activities - Experience in managing process improvement activities - Previous experience of managing teams - Previous experience of developing training and mentoring programs - Experience of working on oncology and rare disease clinical trials. Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.