Home Based - Contract Clinical Study Lead

ProClinical Ltd
London (Greater)
12 Jan 2018
11 Feb 2018
Contract Type
Full Time
A well-known international pharmaceutical company with sites around the globe is looking to hire a Contract Clinical Study Lead. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. The Regional Clinical Site Lead is responsible for in country site management and clinical/medical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and company standards. This role will be home based on a 12-month contract.

Job Overview:

This Regional Clinical Site Lead role is accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g. study start up, enrolment, database release), to safeguard the quality of investigator sites (e.g. site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction.

The Regional Clinical Site Lead is the local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc, and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level.

The Regional Clinical Site Lead is the in country Global Product Development interface with the local country/regional medical affairs teams. When necessary, the role interfaces with the study team and is the conduit from the study team back to the regional clinical site management function. This role supports the Study Team by providing regional / country insights and updates on the evolving local clinical development environment as well as cross-site insights regarding study performance.

The Regional Clinical Site Lead also supports the local clinical development environment to enable the company's interest in clinical development and scientific leadership to be demonstrated. This role is key in providing cross study, and cross site insights into the Clinical Development Portfolio at the country/cluster level.

Skills and Requirements:

* A scientific or technical degree in the healthcare field or an MD / MD equivalent degree along with:
* Extensive knowledge of clinical trial methodologies
* Must be fluent in English. Multi language capabilities are an advantage in this role.
* BS/BSc/MS/MSc or equivalent with demonstrated clinical research experience
* PhD/MD or equivalent with demonstrated clinical research experience.
* Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
* Demonstrated knowledge of global and local regulatory requirements
* Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)
* Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
* Demonstrated ability to participate and support sponsor regulatory interactions/inspections
* Demonstrated knowledge of the processes around protocol design and feasibility assessment
* Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
* Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
* Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
* Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
* Availability to travel within region and/or globally as required

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on Phone number removed or upload your CV on our website - URL removed
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.