to ensure TMF inspection readiness.

+ Uses critical thinking to ensure tasks are proactively scheduled and fulfilled

in line with project team needs.

+ Proactively communicates any risks to project leads and line manager as

appropriate.

+ Supports the maintenance of study specific documentation and global

support with specific systems, tools and trackers, including, but not limited

to, study team lists, tracking of project specific training requirements,

system access management for organization/vendor/clients, and tracking of

project level activity plans in appropriate system(s).

+ Ensures (e)TMF is up to date by following file review schedules and

documents findings in appropriate system(s).

+ Reviews and tracks local regulatory documents. Supports project team to

ensure audit readiness, (e.g., [e]TMF) and contributes to internal, regulatory

and client audit responses as needed.

+ Provides system support (e.g., Activate and eTMF) and ensures systems

databases are always current.

+ Maintains knowledge of and understands SOPs, client SOPs/directives, and

current regulatory guidelines as applicable to services provided.

Ensures that trial status information relating to activities are accurately

maintained in the database and is always current.

+ Trains new personnel on processes and systems. + Contributes to

discussions with teammates in other regions to support a collaborative

network with consistent processes and sharing of best practices.

+ Provides training to other functional team members. + Serves as an

alliance-level lead, handling client (e)TMF activities.

+ Provides technical and administrative support and coordination for

projects in collaboration with relevant internal departments and team

members.

+ aggregate & analyse TMF-related data in BIs TMF System & related tools