Study Start-Up Specialist at BeiGene

General Description :

Support in the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH / GCP, BeiGene SOPs, and local regulations.

Essential Functions of the job :

Familiar with ICH / GCP, relevant country regulations / guidelines, and SOPs

Site Feasibility

Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key information to support with site identification and selection;

Liaise with internal stakeholders (i. e., CRAs, FMDs, CSMs) as needed.

Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected / activated to achieve FPI.

Site Start-Up

Skilled in driving kick-off and completion of tasks from selection through activation.

Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.

ICF / Submissions

Skilled in document management / negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.

Skilled in document preparation and submission to central IRB to ensure timely reviews.

Support in the collection and review of essential documents

Complete SSU data entry in CTMS

Support in the development of local workflows to streamline output and deliverables

Contribute to the ongoing improvement of SSU infrastructure in the Americas - in the U. S., Canada, and Latin America

Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals

Education Required :

Bachelor's degree or higher in a scientific or healthcare discipline preferred with minimum of 2 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

Computer Skills : Intermediate skils in Microsoft Office - Outlook, Word, Excel, PowerPoint, Teams

Other Qualifications :

Knowledge in the execution of clinical trials, understanding of ICH / GCP

Prioritization of tasks in the achievement of goals

Strong written and verbal communication skills

Highly organized

Diligence in follow through

Travel : Up to 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Compensation Information :

$0.0 / - $0.0 /

Starting At : 0.0

Up To : 0.0