Office-based (flexibility to work from 1/2 days per week)
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
Here at inVentiv Health Clinical we are currently recruiting for an experienced CTA to work across a number of different therapy area focused teams within a clinical development department. With this opportunity you will become a permanent employee of inVentiv Health Clinical and be fully embedded into a single sponsor, working solely on their drug development pipeline and contributing directly to the success of their clinical trials. Responsibilities:
- Maintenance of Trial Master File- paper and electronic.
- Attendance and presenting at Study Management Team and other meetings - taking minutes.
- Manage initial set up and access requests for local sponsor and trial site staff to various study systems.
- Tracking patient recruitment, withdrawal and sample collection.
- Compiling Issue Tracking log and lab report query tracking log.
- Reviewing SOP's used within trial managed internally and outsourced.
- Reviewing Monitoring Guidelines to ensure correct collation of all document references.
- Tracking sample collections and paper CRF pages prior to database lock.
- Assisting in the provision of professional and patient materials.
- Downloading data from feasibility system for review.
- Tracking ethics and health authority submissions.
- Reviewing and completing central Trial Master file prior to successful FDA inspection and provision of documents during inspection.
- Assisting in the review and documentation of Investigator and site staff training.
- Maintain Frequently Asked Questions log.
The ideal candidate will need the following experience / skills to be considered:
This role would suit an experienced CTA who is looking to work within a fast paced and challenging Pharmaceutical company. The role is full time, with the flexibility of working from home 2 days a week. The experience of a wide variety of systems for Trial management and document storage is essential. Strong communication skills and the ability of multi-tasking is very important for this role.
There are many benefits available to employees of inVentiv. They include highly competitive compensation and benefits including: 25 days annual leave, sick pay, contributory pension, private healthcare, dental plan, life assurance, childcare vouchers, business travel insurance and personal accident policy management support / career counseling and bonuses!
If you have the required experience for this position and are eligible to work in the UK then please apply by CV.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
Please be aware that due to the volume of applications received, only applicants being considered for this job opening will be contacted for further discussions.