Clinical Data Associate III

Cambridge, MA

Posted: 06/03/2019 Industry: Biotech/R&D/Science Job Number: 48974

The Study Data Manager (SDM) is responsible for the management of clinical data from data receipt through declaring a locked database, including overseeing the timely receipt, review, quality assurance, and documentation in support of global clinical and post-marketing studies, analyses, and filings in compliance with GCPs, SOPs and standards within established timelines and budgets.
  • Develop eCRF design requirements; review and approve eCRF specifications according to protocol and approved standards.
  • Ensure proper documentation/availability (e.g., Data Management Plans)
  • Liaise with and oversee external vendors (e.g., EDC, CROs, laboratories)
  • Provide training for team members in data management procedures.
  • Ensure proper clinical data review and query management
  • Ensure SAE and external data reconciliation
  • Experience with EDC (e.g., Medidata Rave)
  • Familiarity with standard international coding dictionaries (e.g., WHODD, MedDRA).
  • Provide oversight of data management activities to ensure progress according to study timelines.
  • Ensure proper collection and validation of data and documentation on a timely manner
  • Organize study specific meetings (e.g., Patient Validation, Medical Review)

Skills: Capable of interacting effectively with scientists and managers within and outside CSO TO:
  • Strong interpersonal and communication skills (verbal and written)
  • Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills
  • Leadership skills
  • Project Management skills
  • Strong Vendor Management skills
  • Decision-making and problem-solving skills
  • Ability to work autonomously and to efficiently & effectively provide status reports
  • Ability to anticipate and timely escalate issues and to define appropriate action plans
  • Knowledge and qualification with international standards (e.g. GCP, CDISC/CDASH, etc.), EDC (e.g., Medidata Rave), processes and SOPs
  • Experience in managing and leading international meetings (Data Review, etc)
  • Ability to work in an international environment with internal and/or external partners (CROs, etc.)
  • Strong English skills (verbal and written if English is the second language)
  • Ability to adapt and be flexible to change and managing internal and external impediments
  • Familiarity with standard international coding dictionaries (e.g., WHODD, MedDRA).
  • Thorough understanding of database concepts
  • Knowledge of industry data management standards and practices

Education:

Bachelor' s degree plus at least 7 years of experience in pharmaceutical industry or life science-related discipline including at least 5 years data management experience in pharma/biotech.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Lara Coghlan

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