Local Trial Manager (Project Manager - Local Studies)
Field Based - ideally in the South or Central Location
Home-based with potential travel to office in Buckinghamshire
Here at inVentiv Health Clinical we are looking to hire a field based Local Trial Manager to join our business and be fully integrated into one of our pharmaceutical partners.
The Project Manager will act as Local Trial Manager for infectious diseases and oncology studies and will be responsible for managing long-term strategic objectives including quality, timeliness, overall study performance and continuous process improvement. You will be responsible for all clinical trial activities within the UK from study start up through to final close out, ensuring that all organisational and regulatory requirements are met.
inVentiv Health: Work Here. Matters Everywhere.
- Create local country recruitment and study plan, including key timelines and monitoring frequency, communicate to local team and/or to GTM and ensure that it is adhered to
- Notify the GTM when the country and an investigational site is approved to receive clinical drug supplies
- Ensure shipment of drug and non-drug supplies is arranged and monitor the process for the need for additional drug and non-drug supplies as well as relabeling of study drugs or drug transfer if required
- Ensure that current versions of trial documents that are listed on the Site Initiation Report and all required trial-related materials and supplies are provided to the investigational site by the site manager
- Ensure that the central IEC/IRB (or in case of local IRB through site manager) is provided with current and complete copies of all documents that the IEC/IRB requests to fulfil its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
- If applicable, identify local vendors, create and negotiate agreement with these vendors
- Ensure that country-specific requirements for sample handling can be met and that the SMs are properly trained in these requirements
- Highly driven with previous local project management experience
- Solid experience as a Lead / Senior CRA , including experience of study start up
- Experience with any of the mentioned therapeutic areas is a significant advantage
- Flexible to travel within UK
- Strong team player who enjoys coaching others
There are many benefits available to employees of inVentiv. They include highly competitive compensation and benefits including: 25 days annual leave, car allowance, 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 required location 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
inVentiv Health Clinical delivers high quality drug development programs and clinical staffing solutions of all sizes around the world to achieve our vison - Shortening the distance from lab to lifeTM