Site Identification Specialist at PSI CRO

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Identification, Study Startup, Communication, Organizational Skills, Negotiation, Relationship Building, Regulatory Knowledge, Project Management, Clinical Operations, Process Improvement, Due Diligence, Risk Management, Training Development, Database Management, Team Collaboration, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

Company Description PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Based in Shanghai Overall Responsibilities - Maintains and refines the internal site database in cooperation with Study Startup, Clinical Operations and Process Improvement. - Participates in development of improvement strategies for the site identification process, implementation thereof, as well as related training activities. Project Responsibilities - Upon assignment to an awarded study, liaises with Project Management and Study Startup specialists as well as other functions involved to define the main study objectives and the optimal site profile. - Creates the initial list of potential sites. - Communicates with project teams on project/ regional level to fine-tune strategy and methodology of initial and follow-up site contacts depending on indication, regional particularities, and technologies in use. - In cooperation with the project team maintains a study site identification tracker, or an analog thereof, for further site evaluation and selection activities. - Liaises with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives. - In cooperation with Legal, performs due diligence check of regulatory and legal limitations applicable to the recommended investigators or clinical sites. - Participates in project team meetings during study startup, as needed. - Supports the project team throughout study startup and further on, whenever additional rounds of site identification are necessary, and/or additional information on the site/investigator is needed. Qualifications - Bachelor's and above Degree in Medicine, Pharmacy and relevant Life Sciences major. - Minimum 2 years of experience in site identification/ study startup activities. - Excellent knowledge of ICH GCP, local laws and applicable regulations in the region. - Fluent in oral English. - Well-developed communication and organizational skills. - Ability to negotiate and build relationships at all levels. Additional Information Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Responsibilities

The Site Identification Specialist maintains and refines the internal site database and participates in developing improvement strategies for the site identification process. They liaise with project teams to evaluate the status of site identification and perform due diligence checks on recommended investigators or clinical sites.