WuXi AppTec

Senior Clinical Project Manager

Job Locations US
Job ID
2021-8383

Overview

WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.

 

Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”

Responsibilities

Job Summary: The Senior Clinical Project Manager - manages and coordinates clinical project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed.


Essential Job Functions:

  • Performs project oversight in compliance with applicable WuXi Clinical policies, regulations, international standards, and SOPs
  • Applies thorough understanding of FDA Guidelines, ICH, GCP, and other applicable regulations 
  • in overseeing all aspects of clinical research projects (primarily inclusive of complex, full-service and/or global trials) to ensure 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
  • Meet with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects
  • Participate in business development activities, including proposal development and pricing and bid defense meetings, as required
  • Responsible for the management of US and Global projects, and displays very strong customer relations skills
  • Responsible to organize Kick Off Meeting, internal and sponsor tcons, draft internal and sponsor team meeting agendas, host meetings and review/approve meeting minutes
  • Position requires careful management of budgets in order to maximize project profitability
  • Provides operational support for Clinical Operations
  • Provides leadership, training and coordination to matrix project team members that may include Clinical Research Associates, Clinical Project Associates/Specialists, Associate Project Managers, vendors, contractors and consultants as required by the project
  • Demonstrates problem solving ability, taking into consideration sponsor deadlines as well as financial, quality and other important project aspects
  • Ability to work with minimal supervision; able to confidently make project decisions that could have substantial impact on clinical, data quality, or regulatory issues
  • Contributes to the overall operations and to the achievement of departmental goals
  • Other duties as assigned

Qualifications

 

Experience / Education:         

  • Bachelor’s degree in a life sciences discipline desired or equivalent training and experience
  • Must have a minimum 3 years of clinical project management experience in the CRO or pharma industry.
  • Minimum of 5-7 years’ overall of clinical research experience; experience can be a combination of CRO/Pharma industry and Academia/Research institutes, with a stronger emphasis on the CRO/Pharma industry.  
  • Experience in leading multi-service project teams through a complete clinical trial or multiple trials at various stages is required.
  • Good knowledge of clinical, regulatory, and data aspects of trials including, but not limited to field monitoring, data management, biostatistics, and medical writing
  • Advanced knowledge of FDA guidelines and review processes, ICH/GCP compliance and regulations. Knowledge of IND and NDA process preferred. 
  • Project management skills including client management, fiscal/contract management, cohort and vendor management, quality management is required; as well as strong time management skills and the ability to thrive in a fast-paced environment with multiple priorities
  • Solid Microsoft Office Suite (Word, Excel, Powerpoint) as well as experience with tools specific to clinical trial management (e.g. CTMS, EDC, IVRS, eTMF, etc.)

  

Knowledge / Skills / Abilities: 

  • Effectively communicates in clear, concise, professional manner with employees and senior management within company and with peer and senior level customer contacts
  • Strong fluency in English both verbally and in writing and effectively conveys issues and potential resolutions to team members and supervisors
  • Demonstrates active listening and excellent interpersonal skills and exhibits the ability to lead team using appropriate motivational techniques and conflict management approaches with integrity
  • Skilled at presenting topics to groups for the purpose of training, bid defense meetings or other public speaking opportunities
  • Demonstrates a high level of attention to detail and the ability to interact professionally with clients, team members, and investigational sites
  • Travel is required 10%, Domestic/International, Daily / Overnight

  

Physical Requirements:                                                      

  • Ability to stand/sit/walk for long periods of time
  • Ability to Lift 10 lbs occasionally
  • Ability to crouch, bend, twist, and reach
  • Ability to travel via airlines and other means, navigate airports, overnight stays in hotels, and must have a valid driver’s license and the ability to rent a car

 

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.

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