WuXi AppTec

Manager, Clinical Data Management

Job Locations US-CA-San Diego
Job ID
2021-8809

Overview

The Manager, Data Management is responsible for oversight of clinical data management
functions on assigned projects and department line management.

Responsibilities

Essential Job Functions:
• Supervises and/or performs all study-specific data management activities during startup,
maintenance, and study closeout phases and is accountable for all data management activities
• Provides oversight of data management projects to ensure high-quality deliverables, repeat
business, project profitability and generation of new business to achieve annual goals.
• Collaborates with Project Management, Clinical Operations, Quality Control, Quality Assurance,
Pharmacovigilance, etc. on data management aspects of projects and supports project teams
and staff.
• Supervisory responsibilities include, but are not limited to, providing technical and operational
guidance and direction, checking output of work, ensuring deliverables are met, and administering
company policies and performance management
• Manages staff, which may include goal setting, performance management, mentoring, corrective
action, employee separations, leave requests, timesheet reviews, as well as participation in the
interview and selection process, and job description reviews in an office or remote setting
• Provides ongoing training and career development for direct reports and other operational staff, as
applicable.
• Serves as Project Manager for back end service projects and may serve as lead data manager on
complex trials.
• Monitors project financials against budget constraints to maximize project profitability and avoid
mismanagement of project, missed deadlines, poor client satisfaction, and loss of repeat business
• Ensures that standards are observed for database administration, database design, data
capture and data quality control.
• Reviews and/or develops department Standard Operating Procedures (SOP), Work Instructions
(WI), and process documentation
• Participates in business development and client interaction activities as required, including proposal
pricing and bid defense presentations.
• Manages project resources according to budget and notifies project manager and supervisor of any
potential out-of-scope requests from sponsors that would affect project budget or timelines
• Manages successful completion of projects with a focus on customer satisfaction and an emphasis
on generating repeat business
• Ability to work in a team environment and independently as required
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and
WuXi AppTec Policies, SOP, WI and has a thorough understanding of FDA Guidelines, ICH, GCP,
NDA, IND and other applicable regulations
• May be required to assist in other departments or be assigned other duties

Qualifications

Experience / Education:

  • BS or MS in Life Sciences, technical, or related discipline with minimum 6 years of clinical data
    management experience in CRO or Pharma required or minimum of 4 years of clinical data
    management experience and prior management experience. Management or leadership
    experience is preferred
  • Must have experience with DM start up, maintenance, and closeout activities in both paper and
    Electronic Data Capture (EDC) studies.
  • Experience in moderate to complex, paper based, and EDC projects. Global project experience
    preferred.

Knowledge / Skills / Abilities:


• Must have experience with multiple Clinical Data Management Systems (CDMS)
• Excellent oral and written communication skills to interact and build rapport with sponsors, vendors,
and investigative sites
• Ability to work in fast-paced environment
• Ability to effectively communicate issues and potential resolutions to sites, other team members,
project manager, and supervisor
• Must exhibit positive, professional demeanor in all communications and interactions and must be
able to use differing communication strategies to resolve conflicts, lead meetings, and make
presentations to sponsors, employees, management and others as necessary
• Must be able to communicate to coworkers in a positive, constructive manner and must be
comfortable delivering both positive statements and constructive criticism to team members
• Must exhibit concise technical writing skills in English with minimal grammatical or logical errors
• Must have experience in managing clinical trial databases in Pharmaceutical or related industry
• Experience with both paper-based and EDC studies preferred
• Familiarity with SAS including basic programming skills a plus
• Advanced skills with Microsoft Office Suite applications
• Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation
• Must have ability to initiate steps according to established processes without intervention and new processes with minimal guidance
• Must be able to solve problems independently when required and must be able to anticipate risks to the project and to propose solutions to supervisor
• Strong organizational, planning and follow-up skills and the ability to hold others accountable
• Ability to work effectively in fast-paced changing environment and effectively manage multiple
priorities within established time constraints
• Expected to have good working knowledge of Good Clinical Practices and Good Clinical Data
Management Practices
• Ability to work in remote environment independently, but remain engaged with project team,
sponsor, clinical sites, vendors, project manager and supervisor
• Ability to mentor staff

 

Physical Requirements:
• Must be able to travel (Domestic/International, Daily/Overnight,10%)
• Must be able to work in an office environment as necessary, which has minimal noise
conditions or have a home-based office area to work for remote positions
• Ability to stand or sit for most of the work day
• Must be able to perform some activities with repetitive motion, such as keyboard entry
• Must be able to travel for long distances in various methods of transportation (i.e. car, airplane,
shuttle bus, etc.)
• Must be able to navigate to and from site locations, hotels, 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

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