北京招聘

GENERAL DESCRIPTION AND RESPONSIBILITIES:

o Collaborate with Project Management Department colleagues and/or supervisor to support business development activities or tasks as assigned by Business Development Department or the Company.
o Act as a key contact for the Sponsor and Project(s)
o Lead, manage and communicate with multi-functional teams on regional or global interdisciplinary projects/studies to ensure on-time, and within budget deliverables for projects
o Manage clinical projects to meet Company and Sponsor requirements and satisfaction. This includes managing resources, budgets, milestones, timeline and quality
o Plan, initiate, develop and organise clinical trials in accordance to the highest standards required in the good clinical practices, regulatory obligations, investigator integrity and compliance with study protocols and procedures
o Set up , maintain, execute and implement project-related documents, dossiers and files, project databases, project timelines and processes, as well as tracking systems or other tracking/analysis tools for Sponsor and Management
o Review , finalise and approve all study-related regulatory and administrative documents (including investigator study budgets and contracts) from investigator sites, monthly client/site invoices, monthly monitoring reports, work progression reports and other documents
o Plan and coordinate in regular study team meetings and present at the Investigator’s meetings , site initiation meetings and/or site close-out meetings
o Assess project resource requirements on a continual basis to ensure appropriate resources are allocated
o Identify specific training needs and supervise, train and mentor project team/clinical research staff within the company on project related policies, procedures, project management tracking tools, and other relevant SOPs
o Work and coordinate directly with both pharmaceutical and biotechnology companies (collectively refers to sponsors) with overall responsibilities for managing the budget, timelines, qualities of all aspects of the assigned clinical trials/projects
o Work closely with sponsors to oversee the implementation of project specific procedures and requirements to ensure that the study goals and expectations (on-time, on-budget, quality performances) are met
o Measure and keep track team overall performance indices against projected baselines, timeline and milestones to ensure that all project work are completed and delivered to sponsor’s requirements and satisfactions
o Resolve and recommend solutions and manage any deviation from plan or budget

This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.


MINIMUM REQUIREMENTS:

o Bachelor degree, major in nursing, pharmacy or other science-related background from a recognized institution, and/or equivalent combination of training and experience
o Minimum 5 years experience in clinical research, with at least 2 years prior experience in managing projects
o Advance knowledge of ICH-GCP guidelines, local GCP guidelines and regulations in the region
o Good understanding of cross-functional processes, clinical trial processes and the regulatory environments
o Good computer/technology skills including MS Word, MS Excel, PowerPoint, and MS Project (or similar Project Management tools)
o Effective written and verbal communication skills, preferably with good command of Japanese in addition to local language
o Good organizational, leadership and interpersonal skills
o High integrity in personality and professionalism
o Ability to manage time and work independently
o Positive attitude, high degree of initiative and committed
o Self-initiative to perform duties, with good analytical and problem-solving capabilities
o Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
o Meticulous and able to work in a fast-paced environment
o Able to work under pressure and under challenging timelines when required
o Ability to travel when required

* ABOUT US

EPS INTERNATIONAL CO., LTD (EPS INTERNATIONAL), a clinical service provider established by a reputable leading full service Japanese contract research organization – EPS Co. Ltd (EPS), commences its operations in 1999 to provide an integrated, seamless and optimal drug development platform through synergizing EPS’s long-established clinical resources and operations in Asia region to best support increasing outsourcing needs in the research, development and commercialization of pharmaceutical products and medical devices initiated by global and Japanese companies worldwide.
 
We have strong presence in Asia and are fast expanding our footprints in the Pacific, Europe and US.
 
Website www.epsgr.com
 
 
* COMPANY VALUES

In line with EPS’s corporate visions, EPS INTERNATIONAL aims to be an “Ever Progressing System” by continuously delivering quality clinical services, providing efficient and effective turn-key solutions for our Clients’ products development needs in Asia region.
 
 
* COMPANY SUCCESS
 
EPS INTERNATIONAL leverages and applies EPS’s values with many years of combined experiences as an added value to our Clients’ programs ranging from research, development to commercialization in key Asian countries. Lead by a great team of professionals with in-depth experiences and relationships supported by regional clinical networks, key opinion leaders and good performance sites, EPS INTERNATIONAL is the preferred outsourcing partner in Asia.

 
One of the large CRO in Japan and listed on Tokyo Nikki Stock Exchange. We are profitable and have strong and stable financial support from EPS Group.


A full service provider from Bioanalytics (Phase I) to Phase IV to Central lab, patient recruitment services, resource solution to meet clients one-stop shop needs


Strong language capabilities within the team - Japanese, Chinese & English. Known as the best Japanese study CRO service provider.

 
Our Data Management Group has a strong brand and reputation in the industry

 
Comparatively large clinical operation team with wide therapeutic area experience that spans over Asia.