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- Tasks: Lead regional clinical studies, ensuring quality and timely delivery while collaborating with diverse teams.
- Company: BeOne, a rapidly growing company dedicated to fighting cancer.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in cancer research while developing your leadership skills.
- Qualifications: Experience in clinical operations and strong leadership abilities required.
- Other info: Join a dynamic team committed to innovation and excellence in clinical research.
The predicted salary is between 48000 - 84000 Ā£ per year.
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.
General Description:
- Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget.
- Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study.
- Ensures alignment of regional deliverables with overall study goals.
Essential Functions of the job:
Regional Leadership
- Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study.
- Leads external vendors involved in study delivery on a regional level.
- Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required.
- Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings.
- Leads regional operations meetings with all regional study team members.
Timelines, Planning and Execution
- Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines.
- Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these.
- Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders.
- Provides regional input on global study plans as required.
- Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs.
- Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs.
- Ensures regional and country information in study systems and tools is entered and up to date.
- Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports.
- Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QCād on a regular basis as per the study TMF QC plan.
- Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region.
- Manages the trial data collection process for the region, drives data entry and query resolution.
- As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing.
Quality:
- Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads.
- Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations.
- Ensures inspection readiness for study in region at any point in time throughout the study life cycle.
- Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented.
- Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate.
- Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared.
- Leads improvements and partners with CST members to enhance efficiency and the quality of the work performed on assigned studies.
- Contributes to development, optimization and review of work instructions and SOPs as required.
Budget and Resources:
- Works with the sourcing team to select and manage regional study vendors.
- Manages regional study budgets.
- Works closely with Clinical Business Operation on investigator fees, site.
Clinical Study Manager Line Manager in London employer: BeiGene, Ltd.
Contact Detail:
BeiGene, Ltd. Recruiting Team
StudySmarter Expert Advice š¤«
We think this is how you could land Clinical Study Manager Line Manager in London
āØTip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. We canāt stress enough how valuable personal connections can be when it comes to landing that Clinical Study Manager role.
āØTip Number 2
Prepare for interviews by brushing up on your knowledge of clinical operations and study management. We recommend practising common interview questions and scenarios related to regional leadership and compliance, so you can showcase your expertise confidently.
āØTip Number 3
Donāt forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show your genuine interest in the role.
āØTip Number 4
Apply through our website for the best chance at landing your dream job! Weāre always looking for passionate individuals who want to make a difference in cancer research, and applying directly shows your enthusiasm.
We think you need these skills to ace Clinical Study Manager Line Manager in London
Some tips for your application š«”
Tailor Your CV: Make sure your CV is tailored to the Clinical Study Manager role. Highlight your experience in leading clinical operations and managing study timelines, as these are key aspects of the job. We want to see how your background aligns with our mission to fight cancer!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to express your passion for clinical research and how you can contribute to our team. Be specific about your leadership experience and how you've successfully managed studies in the past.
Showcase Collaboration Skills: Since collaboration is crucial for this role, make sure to highlight any experiences where you've worked effectively with cross-functional teams or external partners. We love seeing examples of teamwork that led to successful outcomes!
Apply Through Our Website: We encourage you to apply directly through our website. Itās the best way for us to receive your application and ensures youāre considered for the role. Plus, it shows youāre keen on joining our mission at BeOne!
How to prepare for a job interview at BeiGene, Ltd.
āØKnow Your Stuff
Make sure you brush up on the specifics of clinical study management and BeOne's mission in fighting cancer. Familiarise yourself with their recent studies and any challenges they might be facing. This will show your genuine interest and help you answer questions more confidently.
āØShow Your Leadership Skills
As a Clinical Study Manager, you'll need to lead teams effectively. Prepare examples from your past experiences where you've successfully led a team or resolved conflicts. Highlight your collaborative approach and how you ensure everyone is aligned with study goals.
āØBe Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to study delivery and compliance. Think about how you would handle issues like budget overruns or regulatory challenges. Practising these scenarios can help you articulate your thought process clearly during the interview.
āØAsk Insightful Questions
Prepare thoughtful questions to ask at the end of your interview. Inquire about the team dynamics, current projects, or how BeOne measures success in their studies. This not only shows your enthusiasm but also helps you gauge if the company culture aligns with your values.
