Job Title: Manager, Site Start-Up & Regulatory

Job Code: 01014

Reports To: Associate Director or Director, Site Start-Up & Regulatory; or designee

Summary:

Assists senior managers in managing work and teams within a specific or broad area of site start-up, such as site

activation, regulatory, submissions, site contracts, or regulatory records. Ensures fulfillment of customer

requirements and compliance with related regulations. Analyzes processes and develops strategies to increase

efficiency. Performs operational level planning, including efficient allocation of resources within the department.

Participates in business development presentations as a subject matter expert in Site Start-Up & Regulatory

functions within the Company.

Essential Functions:

1. Approves courses action for staff members on salary administration, interviewing and selection, terminations,

professional development, performance appraisals, job description preparation, and employee counseling.

Works with and advises staff on administrative policies and procedures, technical problems, priorities, and

methods.

2. 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.

3. Supports management with site start-up and financial management tasks of projects, as well as strategy

development for process improvement. Facilitates and supports project reviews with Clinical Operations staff,

focusing on budget, schedule, and risk analysis.

4. Supports management in reviewing, approving, and presenting prepared information at project or departmental

review meetings. Develops and implements training programs for appropriate departmental teams.

5. Interacts with the executive management and Legal Department and assists with the accurate creation and

implementation of site start-up and regulatory management workflows. Identifies and reports on areas of

process and risk.

6. Oversees the implementation of customer-required and enterprise-wide project management systems and tools.

Participates in the development, implementation, and maintenance of enterprise project management systems,

acting as a systems manager; may supervise a systems administrator. Develops requirements for modifications

to existing systems and reports based on input from functional teams. Provides input and requirements for longrange

IT plans. Implements Company and customer-required project management systems and processes.

7. 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. Develops and implements strategies and tools

for tracking contract management team metrics/cycle times. Oversees all quality control efforts of individual

departmental teams.

8. Represents the Company at professional meetings or seminars.

9. Establishes and maintains training materials for assigned area.

This document has been electronically approved. Refer to the Approval Certificate at the end of the document for details.

Manager, Site Start-Up & Regulatory 01014 15May2012

Manager, Site Start-Up & Regulatory Version Date: 15May2012

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Other Responsibilities:

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Note: If there are additional responsibilities that are specific to an individual employee, department, country, or

other grouping, please use the Job Description Addendum Template.

Requirements:

BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent

combination of education and experience. Advanced degree preferred. Moderate experience in a clinical research

organization and related contract management or site start-up experience. Experience managing a staff preferred.

Background in development/management of information systems and process engineering preferred. Thorough

knowledge of applicable regulations, drug development, and clinical project management procedures. Strong

presentation, documentation, and interpersonal skills. Proficient in MS Office (Word, Excel, and PowerPoint), MS

Project, email, and Internet. Ability to handle multiple tasks to meet deadlines, delivering high quality work in a

dynamic environment.

上班地址：汉口路266号申大厦10楼1006室