Company: inVentiv Health Clinical
Closing Date: 24 Oct 16
Salary (£): Negotiable
inVentiv Health Clinical is currently seeking an experienced CTA (Senior Clinical Trial Assistant) for their Late Stage division. The position is offered on a permanent basis and is office based in Maidenhead. Candidates must provide proof of eligibility to work in the UK and must have relevant professional experience working at a CRO. As a Clinical Trial Associate you will be responsible for providing support to global project teams. ...
inVentiv Health Clinical is currently seeking an experienced CTA (Senior Clinical Trial Assistant) for their Late Stage division. The position is offered on a permanent basis and is office based in Maidenhead. Candidates must provide proof of eligibility to work in the UK and must have relevant professional experience working at a CRO.
As a Clinical Trial Associate you will be responsible for providing support to global project teams.
* Experience working with paper and electronic TMFs, with the ability to QC TMF documents is essential for this role.
Other tasks that you will be responsible for include: attending study-team meetings and taking meeting minutes, tracking - as per study needs, ensuring training is up-to-date and documented for study team, sending mass mailings, overseeing investigator grant payments and tracking vendor payments.
This is a great opportunity for someone with solid experience in a smaller CRO that would like to work within a top 5 global CRO, with excellent career development opportunities.
* eTMF and / or pTMF set-up and maintenance / filing.
* QC of eTMF/ pTMF documents and reconciliation of TMF documents against Filing Plan.
* Mass mailings (hard copy or electronic).
* Maintain system and ensure that CRA final report dates are up to date at all times.
* Ensure that training matrix for the project is kept up to date.
* Review on an ongoing basis, training needs for the study members by liaising with the LCRA/ PMOL and ensure that all study specific training is appropriately added into the clinical training system for each study team member.
* Maintain Study Central.
* Prepare and send study binders and other necessary supplies to sites during study start-up and as needed throughout the study.
* Submit documents to Central IRB for approval and to vendor for translations.
* Oversee Investigator grants payments and management of the same, and escalate issues when identified.
* Support of tracking activities [define per study]
* Establish vendor POs, process vendor invoices through COUPA (or other applicable process), and maintain trackers for all study vendor payments.
* Input and support for eTMF Filing Plan draft and annual reviews/updates.
* Assist PMOL/PM on ad hoc issues where needed.
* Study inbox management and update.
* Draft meeting minutes.
* High School Diploma or equivalent
* Competent with Microsoft Office
* Strong written and verbal communication skills
* Relevant professional experience working at a CRO
In return we will offer:
* A competitive remuneration package with excellent benefits.
* A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
* The opportunity to work within a successful and rewarding environment.
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market.
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