Clinical Study Manager- 12 Month Contract
Large Biotech based in either Middlesex or Cambridge
Our client is seeking an experienced study manager or a lead CRA looking for the next step in their career to join there established international study team, with flexibility to be based in either Uxbridge or Cambridge. Our client truly offers a great work environment and culture, twice named as one of the top 100 UK employers.
Join a leading biotech in a role where you will support study delivery from design to reporting within a global matrix setting/CTLs and Lead CRAs should apply. The role requires minimal travel and is office based initially with the potential for home working after orientation. In our experience with this client,^these contracts can offer renewal leading to long term engagements.
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 these roles you must have:
- BSc Hons in Life Sciences or equivalent
- Clinical research experience and an understanding of monitoring practice in Europe with a 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 with risk management to succeed in study operational delivery
- Good communication skills, both written and verbal
You must have a valid driving license, be willing to do some limited travel and demonstrate the collegiate behaviours and dedication working for a top company demands.
MS Office, MS Project, KOL, lifecycle, Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, GCP, Site Manager, Monitor, Clinical Study, Feasibility Essential Documents, GCP, SOPs, Training, Investigator Meeting, REC, Research Ethics. R&D, Trust, SMO, Site Manager, Budget, vendor, RFP, Contracts, C&O. Negotiation, Accruals, Financial
Contact Matthew Pike on 01932 234685 for more information or email email@example.com
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.