北京招聘

Description

Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.

If that is your passion, we have a place for you.

Manager, site start-up (China - Beijing)

RESPONSIBILITIES

· Interface with internal contacts to determine operational strategy and expectations and parameters for the review and negotiation of contracts and regulatory documents.

· Provide Proposal Management with input on proposals and budget development for SSU components of projects. Attend proposal defenses as needed. Create Investigator Grant Estimates for Proposal Management, as necessary.

· Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for SSU components of projects. Review and negotiate regulatory documents, contracts, and contract amendments with

sponsors for agreement on wording and budgets. Ensure accuracy and completeness of documents.

· Where applicable, review and ensure project work instructions for SSU projects are completed and accurate. Provide feedback to SSU leads in the writing of project work instructions.

· Resource staff efficiently to ensure achievement of utilization and SSU realization targets.

· Interact with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.

· Review and analyze site performance metrics and processes to provide input in the development and implementation of process/system improvements.

· Accountable for staff efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines.

· Identify and make recommendations to resolve ongoing training and development needs of staff.

· Manage staff in accordance with organization's policies and applicable laws. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters.

· Mentor SSU Leads and ensure adherence to start-up project timelines, scope of work and budget.

· Serve as SSU Lead for single projects or programs as necessary.

· Serve as SSU advisor for designated clients as necessary.

· May manage site identification activities.

Qualifications

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

· Full knowledge of drug development process

· Full knowledge of applicable regulatory requirements, SOPs, and company's Corporate Standards

· Strong knowledge of budget management and resourcing

· Considerable working knowledge of medical terminology

· Strong knowledge of Microsoft Office and e-mail applications

· Effective communication, organizational, interpersonal, and leadership skills

· Strong negotiation skills

· Ability to independently coordinate and manage new processes

· Ability to lead and motivate teams

· Ability to handle management/personnel issues

· Ability to work independently and to effectively prioritize tasks

· Ability to work well within a matrix team environment

· Ability to establish and maintain effective working relationships with coworkers, managers and clients

ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY