WuXi AppTec

  • Senior Clinical Data Manager

    Job Locations US
    Job ID
    2018-3775
  • Overview

    The Senior Clinical Data Manager performs clinical database setup, maintenance, and data quality control functions through database lock in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and ResearchPoint Global and Sponsor SOPs. This can be either an in-office or WFH position.  SOPs.

    Responsibilities

    •  

      Essential Job Functions:

      • Provides operational support for Data Operations
      • Serves as data management lead interacting directly with sponsor, sites and vendors on complex paper-based or EDC projects under minimal supervision
      • Performs and is accountable for all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database
      • Manages processes to ensure data integrity via appropriate data management processes, such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data or query quality checks, ensuring database updates are applied, etc.) in accordance with approved study documentation
      • Functions as the primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trial
      • Proactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, and defining validation specifications, and database and validation specification testing
      • Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support
      • May lead such meetings and provide formal training as required
      • Performs Business Development functions including but not limited to attendance and participation in client meetings
      • Performs data management study close-out activities including finalizing SAE reconciliation, medical coding, and quality control steps in accordance with RPG Standard Operating Procedures
      • Ensures approved study documentation is maintained and properly stored in the trial master files
      • Supports other team members and provides leadership in this function as needed
      • Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients
      • Notifies project manager and/or supervisor of any potential out-of-scope requests or work issues that will affect project budget or timelines
      • Assists with training and mentoring of study team members on the DM project specific tasks
      • Assists with training employees on departmental procedures and processes and technical tasks
      • 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 on rare occasions
      • Contributes to the overall operations and to the achievement of departmental goals
      • Other duties as assigned
      • May be required to assist in other departments

     

    Qualifications

    • Job Requirements

       

      Experience / Education:         

      • 5- Associates degree with minimum 5 years DM lead experience; or the equivalent industry work experience (5-7 years)BS or MS in Life Sciences or technical degree with 4 years DM lead experience is preferred

      Knowledge / Skills / Abilities: 

      • Must be able to utilize experience and knowledge to make logical and appropriate decisions on a wide range of data management projects and tasks with little or no guidance or supervision
      • Can be depended upon for reliability and judgment. Has respect of peers, sponsors and management
      • Produces quality services and is accountable for project success
      • Must be able to review data management documents and files in advance of Quality Assurance review with high level of accuracy
      • Makes decisions on the quality of the documents and take appropriate action
      • Must make effective decisions on managing tasks within time constraints so that deadlines are not missed
      • Expected to require minimal supervision on issues that can have substantial impact on clinical and data quality issues
      • Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with each
      • Ability to effectively communicate issues and potential resolutions to sites, other team members, project manager, and supervisor
      • Must show excellent interpersonal skills
      • Is comfortable creating & making presentations before clients or prospective clients
      • Must exhibit concise technical writing skills in English with minimal grammatical or logical errors
      • Need to be able to read, write and understand English (bilingual in Mandarin preferred)
      • Must have extensive experience with DM start up, maintenance and closeout activities in both paper and EDC studies
      • Ability to demonstrate knowledge of Good Clinical Practices (GCP), and International Conference on Harmonisation (ICH)
      • Experience in moderate to complex projects, paper based and EDC Databases. Some global project experience preferredExperience with projecting budgets for proposed projects and making capabilities & bid defense presentations
      • Must have experience in managing clinical trial databases in Pharmaceutical or related industry including global projects a plus (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 ResearchPoint Global documentation
      • Must be able to solve problems independently when required and must be able to anticipate and judge risks to the project and to implement or to propose solutions to supervisor when required
      • Must have positive, professional demeanor with all interactions on the phone or in the office
      • Must have ability to effectively deal with complex client interactions
      • Ability to organize workload and handle multiple priorities
      • Ability to work in team environment and effectively manage multiple priorities within established time constraints
      • Ability to mentor staff
      • Expected to have good working knowledge of Good Clinical Practices and Good Clinical Data Management Practices
      • Travel is required 5%, primarily domestic/infrequently international, daily/overnight; if driving, must have valid driver's license and be able to rent a car.

       

       

      Physical Requirements:                  

      • 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
      • If working remote: must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) on an infrequent basis
      • Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop when traveling

       

      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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