Clinical Study Specialist-1

Basic qualifications: 

Associates Degree or equivalent experience

Preferred qualifications: 

Bachelors Degree or equivalent experience preferred

Details: 

The primary objective of this position is to provide Clinical Study Specialist support to the Value Evidence Outcomes (VEO) Department.
To manage Health Outcomes (HO) activities according to GSK operating standards and good clinical practice and to ensure that studies and projects receive the support needed to meet or exceed customer expectations on time and within budget.  
Responsible for accuracy of study and project tracking and management systems.

Basic Experience:
• Experience in pharmaceutical industry or health related field
• Proficiency in multiple software applications
• Comprehensive knowledge of the clinical development process and FDA/ICH/GCP regulations
• Comprehensive knowledge of SOPs, Processes and Procedures relevant to the conduct of HO studies and projects
• Experience in contracting processes
• Able to perform study and project-related tasks with minimal or no oversight

Expected Delivery criteria:

• Responsible for the accuracy and integrity of data within GSK study and project tracking and management systems through independent and proactive gathering, entry and interpretation of information from systems to support studies
• Active participant of or leads HO activity teams as appropriate 
• Responsible for providing operational support to deliver high quality and accurate health outcomes evidence and to ensure compliance with GSK relevant processes, procedures and SOPs
• Facilitate the end-to-end outsourcing process for HO activity vendors and external consultants participating in advisory boards or 1:1 consultancy
• Working closely with contracting groups and study managers to: review and submit contract requests; resolve complex issues; facilitate contract execution as required
• Ensure outsourced activities meet appropriate governance and compliance requirements.  Including: obtaining relevant approvals; perform supplier due diligence assessments; identify studies in scope for Adverse Event Reporting; ensure healthcare professional payments meet GSK payment disclosure policies
• Assist with preparation and execution of confidential disclosure agreements
• Responsible for providing supplier Adverse Event Reporting training and reporting materials and maintaining relevant documentation
• Assist with budget and invoice management
• Providing guidance to study team of relevant governance and compliance requirements
• Develop specific processes and procedures for operationalizing studies and projects and oversee standardization and dissemination of best practices
• Oversee study and project related logistics, resolve complex requests, recognize underlying issues, and communicate issues and proposed solutions as appropriate


If requiring an adjustment for a disability, once selected for
Interview you may contact ukdiversity.recruitment@gsk.com

Closing date for applications: 4th November 2016

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information: 

You may apply for this position online by selecting the Apply now button.