*临床物资发放，辅材设备进出口管理，库存管理，供应商管理等
This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs, the person prepares, collates, distributes and archives clinical documents.
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role will collaborate at local level closely with COM, CRM and CRA.
Responsibilities include, but are not limited to:
61 Trial and site administration:
o Clinical supply & non-clinical supply management, in collaboration with other
country roles
o Manage Labeling requirements and coordinate/sign translation change request
61 Clinical supply and ancillary supply management:
o Conduct clinical supply local purchase when global central sourcing is not available
o Conduct ancillary supply local purchase
61 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 Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Obtain translations of documents
CORE Competency Expectations:
61 Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
61 Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
61 Hands on knowledge of Good Documentation Practices
61 Good IT skills (Use of MS office, use of some clinical IT applications on computer)
and ability to adapt to new IT applications. Strong MS Excel skills required.
61 ICH-GCP Knowledge appropriate to role
61 Excellent negotiation skills for CTCs in finance area
Behavioral Competency Expectations:
61 Effective time management, organizational and interpersonal skills, conflict
management
61 Effective communication with external customers (e.g. sites and investigators)
61 High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
61 Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
61 Demonstrates commitment to Customer focus, both internally and externally.
61 Able to work independently
61 Proactive attitude to solving problems / proposing solutions
Experience Requirements:
61 Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
Educational Requirements:
61 Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.