MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-
year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Under supervision of the ESD Operations and Outsourcing Lead, the ESDS assistant is supporting a wide range of Early Stage trials (also known as phase 1 clinical trials).
The ESDS assistant is an essential member of the trial team. The incumbent will provide operational project support to the Early Stage Development Scientist and is responsible for in-
house activities in compliance with MSD processes to initiate, execute and close out the early stage clinical trials managed by the TPharm EU department.
Core activities include, but are not limited to :
Assemble and provide support for timely Clinical Trial Submissions for clinical trials.
Update, maintain Essential Documents Repository ( Trial Master File ).
Assemble and track availability of all essential documents required for study conduct.
Responsible for periodic in-house reconciliation of all essential documents in the electronic Trial Master File
Update, maintain and monitor Clinial Trial Management System to allow accurate project management, regulatory reporting and clinical grants payments
Follow-up on release, return and destruction of Investigational Medicinal Product
Act as relationship manager with 3rd party vendors for set-up of blood samples shipments or with support groups such as ancillary supplies management
Operational and project support activities, including, but not limited to :
Review compliance of site staff vs non study specific training requirements
Provide professional presentation of study materials for investigator / vendor or country operations meetings
Update operational trackers
Organization and documentation (minutes) of project team meetings
Review study budgets / clinical trial agreements for consistency with study protocol
Possibility for SME role : CTMS, TMF steward, maintenance of ESDS Asst job-aids
Background & Experience
Master’s degree or bachelor with 3-5 years experience in clinical research operations
Skills Required :
Understanding and knowledge of study protocols and study working documents, lab manuals, etc.
Interpersonal skills and ability to work in a team environment
Advanced organization and planning skills
Advanced communication skills (written and verbal) in local languages and English
Advanced computer skills : e.g. professional using of MS Office programs for daily business
Good understanding of the clinical research processes
Understanding of the ICH / GCP and local clinical trial regulations
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
At MSD, we’re inventing for life.