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Clinical Trials Manager US
- Clinical Trials Manager
About Our Client
Our client is fast growing company specialised in neurosciences.
- The overall efficient day-to-day management of the CRO and other service providers in charge for US trial.
- Recruitment, retention, training, appraisal and supervision of trial team and CROs members.
- Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
- Ensuring the timely recruitment and on-boarding of all necessary trial providers in all needed functions and compliant with company SOPs for selection and contracting.
- Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
- Management of the trial budget(s) and maintenance of the accounts.
- Act as the point of contact for all external and internal agencies.
- Co-ordinate the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements.
- Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes.
- Liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements as applies.
- Provision of regular and ad hoc information, both written and verbal, to all the trial participants and sponsors, to include reports, updates, guidance, proformed commitments and possibly a newsletter.
- Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
- Ensure the inclusion of consumer group representatives at the appropriate levels and times.
- Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
- Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
- Assurance that personal and confidential information is restricted to those entitled to know.
The Successful Applicant
- Education: Master Neuroscience/ Life Sciences Preferred
- Experience: Minimum of four years' experience in support of US clinical research project teams for a CRO or pharmaceutical/biotech company.
Knowledge and experience in the following areas:
- General knowledge of applicable clinical research principles, processes and requirements; including IND, GCP and ICH guidelines
- Advanced knowledge of clinical study processes with special focus in the USA
- Strong computer literacy including proficiency in Microsoft Word, Excel and PowerPoint
- English Fluent
- Strong written and verbal communication skills
- Effective project management, time management and organisational skills
- Ability to multitask with significant attention to detail
- Highly effective interpersonal and customer service skills
What's on Offer
Great opportunity to join a quite experience team working on a compound with a very solid ground for being successful.