Newly created clinical study management role in a commercially successful bio-tech company in Middlesex. Join a new team, working internationally in HIV, hepatitis and cardiovascular medicine. Permanent.
A significant position for^a capable senior CRA or junior study manager to step up and assist with the management of international projects. In Europe. What does that mean? Well, it's an unusual opening, a newly created post which will, support with EU programme leaders to^assist with study delivery outside the USA. Working closely with newly-appointed therapy area leaders, you will have access to mentorship of high quality.
The ideal person will be someone who has managed clinical sites or studies beyond the UK,and who is able to assess risk and drive communication. This individual is likely to be interested in best practice for study management and someone eager to really work with European management to help drive studies forward through influence ratherthan through direct authority.
Essential Skills & Qualifications Required
BSc Life Sciences, MSc or PhD would be advantageous
Clinical study monitoring and / or management experience in pharmaceutical industry in the EU
Experience in affiliate Clinical Drug Development
Fluency in English, both oral and written communications
Extensive experience of clinical trial process working within a global matrix
Extensive knowledge of ICH GCP, national regulations & associated EUDirectives
Excellent understanding of clinical trial cycle times & associated metrics
Therapy area knowledge in HIV, hepatitis or cardiovascular indications
Software Competence Required
Good level of MS Office
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: West London/M25
Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, CTA, GCP, Site Manager, Monitor, Manager, Study Manager, EUCTD, ICH GCP,Project Manager, Clinical Study, Clinical Programme, Feasibility Essential Documents, GCP,SOPs, Compliance,Training, Investigator Meeting, REC, Research, Budget, vendor, RFP, variation, scope, outsource, CRO selection, Contracts, Clinical Trial Agreements, C&O. Bids, Proposals, Negotiation, Accruals, Financial
Assigned Consultant: Avril Horn on 01932 234686
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicantswill only receive feedback if they are suited to the role. The role may have been remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We are unable to respond to applicants who are not EU nationals unless they include evidence of right to work in full time employment with their application. Do apply with relevant information on required location or salary/day rate if you are a new candidate.