Overview

The Project Manager II will manage and coordinate clinical and/or data project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed. Preference for in-office over work from home with occasional travel depending on project.

Responsibilities

Essential Job Functions:

• Provides operational support for Clinical Operations
• Oversee all aspects of clinical, data, and/or other contracted activities on clinical research projects (including full-service and/or global trials) in order to assure applicable regulations, standard operating procedures and sponsor requirements are met
• Perform contract and financial management activities for assigned trials and serve as central point of contact with sponsor for project updates
• Serve as supervisor, resource, mentor, and motivator to team members
• Meet with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects
• Participate in business development activities, as required
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
• Normally receives minimal instructions on routine work and detailed instructions on new assignments
• Works under close supervision from supervisor or senior personnel
• Ability to work in a team environment and independently as required
• May be required to work Holidays and weekends

• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures

• Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
• Other duties as assigned
• May be required to assist in other departments

Qualifications

Job Requirements

Experience / Education:         

• 2 years of relevant clinical research and project management experience or equivalent
• 2 years of experience directly managing employees
• Bachelor’s Degree or equivalent experience

Knowledge / Skills / Abilities: 

• Good working knowledge of physician care in hospitals, clinics, or other healthcare settings
• Good knowledge of FDA guidelines and review processes, IND and NDA processes, and GCPs; project management skills including client management, fiscal/contract management, and quality management; as well as strong time management skills and the ability to thrive in a stressful environment with multiple priorities
• Demonstrates a high level of attention to detail and the ability to interact professionally with clients, team members, and investigational sites
• Solid knowledge of computers and Microsoft Office Suite of products as well as experience with tools specific to clinical trial management (e.g. CTMS, EDC, IVRS, eTMF, etc.)
• Need to be able to read, write and understand English
• Effectively communicates in clear, concise, professional manner with employees and senior management within company and with peer and senior level customer contacts
• Communicate well both verbally and in writing and effectively conveys issues and potential resolutions to team members and supervisors
• Demonstrates active listening and excellent interpersonal communication skills and exhibits ability to lead team using appropriate motivational techniques, conflict management approaches, and consistent integrity
• Comfortable presenting topics to groups for the purpose of training, bid defense meetings or other public speaking opportunities
• Demonstrates problem solving ability, taking into consideration time, financial, quality, and customer relations
• Independently extrapolates and applies relevant decisions from previous discussions to new situations
• Recognizes and consults with supervisor on project decisions that could have substantial impact on clinical, data quality, or regulatory issues
• Travel is required 10-20% (depending on project) , primarily domestic/infrequently international, daily/overnight
• Must have a valid driver’s license and the ability to rent a car

Physical Requirements:  [Adjust as needed for travel requirements or other]    

• Must be able to work in an office environment, which has minimal noise conditions
• Ability to stand or sit for most of the work day
• Must be able to perform some activities with repetitive motion, such as keyboarding
• Must be able to travel for long distances in various methods of transportation (ie. car, airplane, shuttle bus, etc.)
• Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.