Senior Associate, Clinical Research

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From MSD’s original posting

Job Description Senior Associate, Clinical Research Responsibilities include, but are not limited to: • Trial and site administration: o Track (e.g. essential documents) and report (e.g. Safety Reports) o Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers o Clinical supply & non-clinical supply management, in collaboration with other country roles o Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable) • Document management: o Prepare documents and correspondence o Collate, distribute/ship, and archive clinical documents, e.g. eTMF o Assist with eTMF reconciliation o Execute eTMF Quality Control Plan o Update manuals/documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies. o Prepare Investigator trial file binders o Obtain translations of documents • Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to: o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions o Obtain, track and…