Clinical Data Associate III (19-00558) – MA – Cambridge

Duties: 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 GCP's, 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

Source: Job Diva – Job Listing

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