Welcome page Returning Candidate? Log back in! Clinical Data Manager II Job Locations US-CA Job ID 2021-8033 Overview

The Clinical Data Manager II 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 Pharmapace and/or WuXi Clinical and/or Sponsor SOPs. This position can either be In-Office or work from home with less than 20% travel.

Responsibilities Provides operational support for Data OperationsServes as data management lead interacting directly with sponsor, sites and vendors on medium complexity paper-based or EDC projects with moderate to minimal supervisionPerforms 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 databaseManages 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 documentationFunctions as the primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trialProactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, and defining validation specifications, and database and validation specification testingParticipates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management supportMay lead such meetings and provide formal training as requiredPerforms Business Development functions including but not limited to attendance and participation in client meetingsPerforms data management study close-out activities including finalizing SAE reconciliation, medical coding, and quality control steps in accordance with WuXi Clinical Standard Operating ProceduresEnsures approved study documentation is maintained and properly stored in the trial master filesManages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clientsNotifies project manager and supervisor of any potential out-of-scope requests or work issues that will affect project budget or timelinesAssists with training and mentoring of study team members on the DM project specific tasksMay assist with departmental trainingMinimal data error rates at database lock as defined in the SOP'sNo unlocks of databases due to data errorsQuery and data entry rates considered acceptable per terms of contractAccuracy of data updatesQuality of documentation and accountability of workAdherence to timelines and budgetsOrganization and coordination on multiple projectsTrain and mentor junior level staff in general team leadership skills, company processes, and project specific tasksGood understanding of departmental and company procedures which relate to tasks that are performed routinelySuccessful completion of projects with a focus on customer satisfaction and an emphasis on generating repeat businessPosition requires employee be aware of budget constraints for time for data entry, query rates, and time to perform other data functionsExpected to manage to those constraints and to alert project manager and manager if they cannot be effectively managedMismanagement of these aspects and high data error rates could result in missed deadlines, potentially affecting project profitability, opportunities for repeat business, contract bonuses or penaltiesMay provide technical leadership and coordination of data-related project activities to other team membersInteracts closely with project manager and supervisor to provide project/budget updates. Receives formal administrative supervision from DM Manager or aboveReceives moderate to minimal supervision from project managers and supervisor, depending on complexity of project workIn lead assignments, responsibilities may include: coordination of other team members; decision-making with data management tasks and processes that are project-specific; providing technical and project guidance and training to other team members; monitoring project status and reporting project metrics; maintaining project timelines ensuring tasks and deliverables are on-time; and, may serve as main point of contact with sponsor and vendors for data-related activities on assigned projectsAbility to work in a team environment and independently as requiredPerform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating ProceduresThorough 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

Experience / Education:         

Associates degree with minimum 4 years DM lead experience; or the equivalent industry work experience (4-6 years)BS or MS in Life Sciences or technical degree with 3 years DM lead experience is preferredMust have experience with DM start up, maintenance and closeout activities in both paper and EDC studiesExperience in moderate to complex projects, paper based and EDC Databases. Some global project experience preferred

 

Knowledge / Skills / Abilities:

Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with eachAbility to effectively communicate issues and potential resolutions to sites, other team members, project manager, and supervisorMust show excellent interpersonal skillsMust exhibit positive, professional in demeanor in all communications and interactions and must be able to use differing communications strategies to resolve conflicts, lead meetings, and make presentations to sponsors, employees, management and others as necessaryMust be able to communicate to coworkers in a positive, constructive manner and must be comfortable delivering both positive statements and constructive criticism to team membersMust exhibit concise technical writing skills in English with minimal grammatical or logical errorsMust have experience in managing clinical trial databases in Pharmaceutical or related industryExperience with both paper-based and EDC studies preferredFamiliarity with SAS including basic programming skills a plusOther programming skills also preferredAdvanced 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 guidanceMust have ability to interact with internal and external customers professionally, using clear dictionMust be able to solve problems independently when required and must be able to anticipate risks to the project within the scope of the position and to propose solutions to supervisorMust have positive, professional demeanor with all interactions on the phone or in the officeAbility to organize workload and handle multiple prioritiesAbility to work in team environment and effectively manage multiple priorities within established time constraintsExpected to have good working knowledge of Good Clinical Practices and Good Clinical Data Management PracticesAbility to occasionally work in remote environment independently, but remain engaged with project team, sponsor, clinical sites, vendors, project manager and supervisorAbility to mentor staffTravel is required less than 10%, Domestic/International, Daily / Overnight

 Physical Requirements: 

Must be able to travelMust be able to work in an office environment, which has minimal noise conditionsAbility to stand or sit for most of the work dayMust be able to perform some activities with repetitive motion, such as keyboardingMust 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, hotel, and airports with personal luggage and laptop

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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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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