I am working on an exciting new role for a fast growing Clinical Research Organisation who are seeking an experienced Clinical Study Manager to join the business ASAP. The core purpose of the role is to aid in the development of new drug and device therapies by supporting the setup, approvals process and co-ordination of assigned studies in accordance with the company’s SOPs, GCP and ICH and relevant US/EU legislation
- Proactively engaging in risk management activities to ensure key milestones and project deliverables are met according to both the business and client requirements.
- Accountability to meet the financial performance targets for assigned studies, responsible for performing forecasting, revenue recognition, maintaining profit margin and to proactively identify out of scope activities and execute necessary work scope change orders.
- Establishing relationships with client teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business plus responsibility for appropriate issue escalation
- Preparing regular communications/reports to client/sponsor/Investigation sites
- Organising and coordinate meetings and events as required on behalf of client/sponsor, circulating agendas and other information in advance and writing and disseminating minutes
- Developing the clinical study protocol and ensure input, review and finalisation occurs within budget and timelines.
- Overseeing and/or creating all relevant operational documents required for the smooth running of the study, including project, monitoring, communication, quality and safety management plans according to my client’s SOPs
- Completion/oversight of Ethics Committee (EC) and Competent Authority (CA) clinical trial applications in accordance with my client’s SOPs
- Conducting study Quality Control (QC) activities throughout the study lifecycle to ensure study processes are in line and compliant with regulations and in accordance with SOPs/WIs
- Working alongside CTAs to ensure assigned projects have an appropriate clinical trial file, including Trial Master Files (TMF), In-House Investigator Site Files (hISFs), Investigator Site Files (ISFs), Pharmacy Files (PF), Laboratory Files, and in-house electronic files and are audit ready. Plus ensuring distribution of essential documents (protocols, brochures, clinical study reports etc)
- Supporting monitoring activities for assigned projects by assisting the study CRA in preparation investigational sites, and follow up tasks as well as accompanying the study CRA on site visits as required
- Supporting study close out activities for assigned projects, including preparation of study documentation for archive, and collaborate with the site archivist to organise off-site archiving in accordance with applicable regulations
- Initiating and driving improvements to enhance efficiency and quality.
- Supporting with the preparation of new SOPs and documents as required.
- Complete time-sheets for each project assigned
Knowledge and skills
- Minimum of 1-2+ years demonstrated clinical research experience in a pharmaceutical company/CRO/CTU as a study coordinator/study manager/project manager)
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Strong organisational and time management skills, strong attention to detail, excellent interpersonal skills both written and verbal. Ability to confidently communicate with an array of internal and external contacts as well as working well independently and as part of a team
- Financial awareness and ability to actively utilize financial tracking systems
- Willingness to travel on an occasional basis
- Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
- Experience of early phase work
- Familiarity with ISO 14155 and the Medical Devices Directives (as amended)
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