Clinical Trial Manager Pharmaceutical Company UK or Netherlands
We are looking for an experience Clinical Trial Manager to join a leading pharmaceutical company. You will be responsible for the oversight and management of studies across all operational aspects of assigned studies within phases I-IV whilst ensuring data quality and integrity alongside patient safety.
Purpose Of Role
The clinical trial manager will be responsible for overseeing and managing insourced or outsourced studies including all operational aspects of assigned phase I IV clinical trial(s), whilst ensuring patient safety, data quality and integrity.
Responsible for operational execution of global/regional Phase I-IV studies. Manages trial deliverables as well as CRO and vendor relationship and performance to ensure that clinical studies are completed in accordance with contract specifications and managements expectations of time, cost and quality.
Develops outsourcing specifications for vendor requests for proposal, leads vendor selection and oversees vendor management throughout the life of assigned clinical trial(s).
Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO and third-party vendors (direct service and pass through costs); as well as oversee scope change negotiations. Oversees overall study level budget and appropriate invoices for all vendors.
Oversees study activities including study start-up, close out, and completion of Trial Master File. Ensures oversight of clinical trials including the selection of investigational sites, adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with study/ site personnel. Monitor all vendors/ CRO performance, communicate vendor expectations, and track vendor performance metrics.
Responsible for overseeing negotiation of site CTAs in conjunction with the Legal Department and CRO/contracts vendor.
Delegates and manages tasks and responsibilities to other team members assigned to the study (ies).
In collaboration with the CRO/vendor oversees operational study level feasibility, recruitment strategies and the delivery of the approved study protocol.
Responsible for providing program director regular status updates.
Ability to travel up to 20% including possible international travel.
BA/BS in life sciences or equivalent
At least 4 years of clinical research experience including at least two (2) years having effectively led a study/studies project from inception to completion coupled with demonstrated ability to hold team members accountable
Global experience of drug development ideally obtained in a biotech/pharma setting
Knowledge, competencies and skills Working knowledge of Good Clinical Practices (GCP), EU Clinical Trials Directive / Regulation and expectations for MHRA GCP Inspections. Awareness of FDA regulations and guidelines with respect to clinical trials, and applicable international regulatory requirements
Must be located in UK or Netherlands.
For more information please do get in touch with Danielle on Danielle.Boniface@cpl.com or call 0118 995 2208
- Agency: Cpl Life Sciences
- Contact: Danielle Bonniface
- Reference: JO-2108-475016_2
Website: Cpl Life Sciences
- Posted: 25th August 2021
- Expires: 22nd September 2021