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Clinical Data Manager

Description:

 

Key contact partner for (i) data collection/curation, data review, data delivery, (ii) data standardization or (iii) process definition, testing and training. 

 

Collect, ingest, structure, curate and standardize clinical trial related data from internal and external sources. Ensure data quality and integrity by implementing plausibility checks, anomaly detection, and fraud detection methods in data collection systems.

 

Supports the clinical research development process through the provision of advanced expertise in the areas of (i) data collection/curation, data review, delivery (ii) data standardization or (iii) process definition, testing and training.

 

This position interprets clinical requirements to translate and document them into technical specifications for new substances, indications or marketing claims.

 

Duties & Responsibilities:

  • Accountable/Responsible to interpret requirements to translate and document them into technical specifications in clinical trials.  Provision clinical trial data to business consumers. Facilitate requirements gathering from consumers and develop global solutions to meet immediate and long-term needs of the business. Monitor and maintain ongoing operations of clinical data environments and respond to issues.
  • Leads and oversees all clinical data management tasks performed by an external partner. Oversees CRO capacities/budget for outsourced tasks.
  • Develop/test different ways to constantly improve data reliability, integrity and quality.  Ensures real-time inspection readiness of all data collection, data review deliverables for clinical trials and participates in regulatory agency and Company internal audits as necessary. 
  • Collaborate with members of the development team at Company on the project goals. Contributes to cross-functional and team-based thinking.
  • Keep abreast of data science and in particular new data collection/curation/standardization/digital tech solutions and innovative processes/tools within and outside Company. Turn derived insights into new clinical data management approaches relevant for clinical development, registration, and marketing of drugs. 
  • Conduct and support data collection/curation/standards process and tool trainings for data managers.
  • Participate in or lead cross-functional Company internal process development teams and drive/plan relevant clinical data management (data collection/curation/standardization) aspects.

 

Requirements:

  • MUST BE LOCATED IN THE CONTINENTAL UNITED STATES
  • Bachelor’s degree from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with more than or equal to nine (>/= 9)) years of professional experience; Or
  • Master’s degree (e.g. MBA, MSc) from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with greater than or equal to five (5) years of professional experience.
  • Initial experience within the pharmaceutical industry or CROs. 
  • Broad knowledge and advanced experience in understanding of clinical trial development process required.
  • In-depth knowledge and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, Data Standardization methods and/or basic SAS/SQL programming skill required.
  • Thorough knowledge/experience in design of clinical trials, basic medical terminology and on processing clinical trial information.
  • Demonstrated ability to build/test, curate, oversee and interpret data in complex clinical trials with established experience. 
  • Intellectual curiosity to find new and unusual ways solving data collection / curation / standardization / process definition, testing and training issues.
  • Excellent organizational skills, problem solving abilities, negotiation skills and time management skills required.
  • Strong communication skills: Confident and persuasive communicator to ensure that the message is clear and well understood. 
  • Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors required.
  • Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
  • Ability to lead and facilitate meetings required.
  • Ability to develop and deliver (technical) training required.
  • Language skills: English: fluent (Read/Write/Speak).
  • Know, understand, and implement:
    • International regulations and guidelines for good clinical and statistical practice from all ICH regions
    • The various international guidelines on clinical development, data standardization, and
    • Company processes and SOPs that govern clinical development.
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