Associate Director, Clinical Operations

Wuxi Apptec Austin , TX 78719

Posted 3 weeks ago

Overview

Job Summary: The Associate Director, Clinical Operations provides leadership as a member of the senior management team overseeing the day to day activities of the project management team and clinical operations team; assists with the evaluation and implementation of systems and process to support efficient performance; and manages and coordinates clinical and/or data project services for sponsors to assure project/program milestones are met and applicable regulations are followed. This can be a work from home position and requires approximately 20% travel.

Responsibilities

Essential Job Functions:

  • Provides operational support for Clinical Operations

  • Serves as Program or Project Director or Senior Project Manager for large or complex projects

  • Serves as supervisor, resource, mentor, trainer and motivator to team members

  • Oversees work of Project Managers including assessing quality, financial health, and customer relations

  • Assists with development of systems and procedures for effective project management and clinical operations

  • Participates in business development activities as required, including proposal pricing and bid defense meetings

  • Assists with yearly departmental budgeting

  • Performs training within company

  • 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:

  • Minimum of 8 years directly related clinical research experience in CRO, pharma, biotech/device company with 6 years of directly related project management experience including a minimum of 4 years supervising clinical and/or data project professionals

  • Experience leading multi-service project teams from study startup through clinical/statistical report. Demonstrates advanced knowledge of clinical, regulatory, and data aspects of trials including, but not limited to, field monitoring, data management, biostatistics, and medical writing. International experience is a plus

  • Bachelor's degree or HS diploma with commensurate experience

  • Graduate degree preferred

Knowledge / Skills / Abilities:

  • Good problem solving skills involving considerations of time, finance, quality, and customer relations

  • Makes autonomous day-to-day decisions on projects including decisions on budget, contract and client management issues with little or no guidance

  • Effectively communicates in clear, concise, professional manner with employees and senior management as well as with external peers and senior level customer contacts

  • Communicates well both verbally and in writing and effectively conveys issues and autonomously implements resolutions for team members

  • Demonstrates excellent interpersonal communication skills and exhibits the ability to lead teams using appropriate motivational techniques, conflict management approaches, and consistent integrity

  • Active and effective listener

  • Skilled at presenting topics to groups for the purpose of training, bid defense meetings or other public speaking opportunities

  • Excellent organizational and negotiation skills

  • Good working knowledge of physician care in hospitals, clinics, or other healthcare settings

  • Show advanced knowledge of FDA guidelines, ICH, GCP, NDA, IND, and other applicable regulations; 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.)

  • Good management skills including the ability to hire, coach/counsel, and terminate employees

  • Capable of creating career plans and monitoring progress

  • Analyzes resource usage with available tools

  • Approximately 20% travel required; must have valid driver's license and be able to rent a car

Physical Requirements:

  • Must be able to work in an office or medical site

  • 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.)

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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Associate Director, Clinical Operations

Wuxi Apptec