北京招聘

JOB SUMMARY

 

The Project Specialist performs administrative and supportive activities assigned by the Project Lead to ensure the contracted services and expectations are carried out by the project team in accordance with executed contracts and the customers’ expectations. 

JOB RESPONSIBILITIES

 

 

• Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.

• Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.

• Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.

• Provide administrative support to Project Leads and functional leads.

• Ensure all study documents are archived based on the appropriate guidelines and policy.

• Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

 

 

QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)

 

• Associates Degree (or equivalent)  level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field  or equivalent combination of education and experience

• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

• Strong organizational skills.

• Ability to manage time and work independently.

• High proficiency with full MS Office Applications.

• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

• Ability to travel if necessary preferred (approximately 5%)

• High level of competence in English language

Why Syneos HealthTM? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.