**Associate Study Manager - Urgently needed in either Middlesex or Cambridge**
My client is seeking a high calibre scientist with excellent clinical R&D skills to join their International team.
My client is a leading Fortune 500, BiotechnologyCompany. With headquarters in the USA, my client employs over 500 staff in their UK offices, located in Cambridge and Middlesex on both a permanent and contract basis.
A market leader, my client strives to develop products that change peoples lives and in the last 30 years have transformed the management of anaemia, inflammation, and cancer. They have a thriving pipeline and are currently very active in recruiting candidates to join the team on a contract basis.
My client knows they offer^ a great place to work. They understand that each candidate is not the same, and no two roles are either. That's why they permit up to two days working from home per week depending on the role. Moreover, it's a place where you will be more than a contractor- you will be one of the team.
The key responsibilities in this role are:
- Contribute to the design, content, and preparation of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets
- Assist in the identification of/identify clinical trial investigators
- Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings
- Work with the Clinical Research Study Manager and CRAs to develop recruitment strategies
- Coordinate study-level IMP , accountability and reconciliation
- Participate in and support study teams
- Coordinate activities associated with site start-up and management including review site-modified informed consent templates and tracking of the budget and contract process
To be considered for this role you must have:
- BSc Hons in Life Sciences or equivalent
- Clinical research experience and an understanding of monitoring practice in Europe witha CRO or Pharma
- Experience of working with external vendors, e.g. IVRS,labs or clinical vendors
- Ability to understand scientific information
- Experience with liaison with external vendors
- An innate ability to foresee issues and deal withrisk management to succeed in study operational delivery
- Good communication skills, both written and verbal
You must have a valid driving license and be willing to do some limited travel
Employment Information:
Employer: PharmaceuticalCompany
Employment Type: Client Contract/Agency Contract
Hours:Part Time
Contract Term: 12 Months
Location: M4/Middlesex/Cambridge
Plan Start Date: ASAP
Contract Benefits: Day Rate inclusive of benefits
Keywords:
MS Office, MS Project,ClinicalResearch, 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 Ethics. R&D, Trust, SMO, Site Manager, Quality Control, QC, EDC
Assigned Consultant: Matthew Pike at CSL Recruitment on 01932 23468 or matthew@cslrecruitment.com
Please feel free to call/email for a detailed Job Description or additional information
Please note -Due to the number of applications we receive, if you have not had a response to your application or an interview request within 4 weeks, you have not been selected for the first screening round.