Site Start Up and Regulatory Manager

A Leading Global CRO are seeking to appoint a Site Start-Up & Regulatory
Manager to assist Senior Managers in managing work and teams within a specific
or broad area of site start-up. This may include areas such as site activation,
regulatory, submissions, site contracts or regulatory records.

Main Responsibilities (to include but not be limited to):
+ Approves courses of action for staff members, and advises staff on
administrative policies and procedures, technical problems, priorities and
methods
+ Facilitates processes, resourcing, and communications within a department,
across departments, or within the country assigned
+ Acts as liaison and facilitator between customer leaders and senior
management for related tasks and/or issues
+ Plans and negotiates resources with line management of functional areas
+ Supports management with site start-up and financial management tasks of
projects, as well as strategy development for process improvement
+ Interacts with the executive management and Legal Department and assists
with the accurate creation and implementation of site start-up and regulatory
management workflows
+ Oversees the implementation of customer-required and enterprise-wide
project management systems and tools
+ Leads teams of subject matter experts in the development and review of
Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new
or existing processes

Skills/Experience:
+ BA/BS Degree in Business Administration, Public Administration, Public
Health, related field, or equivalent combination of education and experience
+ Moderate experience in a clinical research organisation and related
contract management or site start-up experience
+ Previous line management experience is essential
+ Must have experience managing International projects
+ Thorough knowledge of applicable regulations, drug development, and
clinical project management procedures

This is a fantastic opportunity for the successful candidate to secure a permanent position within a reputable company.

To find out more about Real Staffing please visit www.realstaffing.com