(Senior) Study Start-up Specialist
BeiGene
This listing was originally posted on BeiGene's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moAbout us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
Lead the delivery of study start-up, maintenance, and closeout activities, including initial and ongoing submissions, within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, local regulations, as well as BeiGene culture and Values. Whilst leading or contributing to process improvement and excellence initiatives. Support other SSUs as required
Essential Functions of the job:
Contribute to Submission strategies
Lead or Support the delivery of clinical start-up component of assigned studies with accountability for time, cost and quality for assigned activities, which include, but not limited to,
Prepare and execute study submissions packages for IRB/IEC, Regulatory Authorities, Institutions, and any other submission requirements as needed
Clinical trial site contract and budget negotiation, if required
Support other functions as needed to ensure timely start up
Site Feasibility, if required
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.
Support in the collection and review of essential documents
Implements best practices and shares lessons learned with team and other colleagues, as appropriate.
Proactively identify potential issues and seek improvement. Takes the initiative for issue resolution within and outside Study Start Up team.
Actively involved in company process improvement initiatives
Complete and maintain company systems including CTMS and eTMF
Establish, maintain and enhance relationship with internal and external stakeholders
Mentor junior staff as required
Perform additional tasks as assigned Management.
Supervisory Responsibilities:
Not applicable
Qualification Required:
Bachelor’s degree or higher in a scientific or healthcare discipline. Experience may discretionarily substitute for degree.
Computer Skills: Intermediate skils in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams, SharePoint,
Other Qualifications:
At least 2 years experience in a similar role
Fluent in local language/s as well as written and verbal English
Strong interpersonal skills, can do attitude and problem-solving skills
Able to multi-task and meet compressed timelines Knowledge in the execution of clinical trials, understanding of ICH/GCP
Prioritization of tasks in the achievement of goals
Highly organized
Diligence in follow through
Travel: Up to 10%
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
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