Clinical Research Associate Line Manager

BeiGene; Remote; GBP 60,000 - 85,000; Full time

Job summary

A leading global biotechnology company is seeking a Clinical Research Associate Line Manager in the UK. You will oversee study startup and monitoring staff, ensuring compliance with clinical protocols while mentoring junior staff. This role demands a bachelor's degree in a scientific field and 5-7 years of relevant clinical operations experience, preferably with at least 2 years of line management, alongside excellent leadership and organizational skills. The position requires fluency in English and the ability to handle multiple tasks effectively.

Qualifications

• Minimum of 5-7 years experience in clinical operations, preferably in pharma or CRO.
• Ability to manage multiple priorities in a fast-paced environment.
• Fluent in English (writing and speaking).

Responsibilities

• Act as line manager for study startup and trial monitoring staff.
• Ensure quality and oversight of clinical work through evaluations.
• Mentor junior staff and conduct performance appraisals.

Skills

Leadership

Project management

Clinical operations knowledge

Interpersonal skills

Organizational skills

Analytical Thinking

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

MS Project

MS PowerPoint

Outlook

Job description

Clinical Research Associate Line Manager page is loaded## Clinical Research Associate Line Managerlocations: United Kingdom Remotetime type: Full timeposted on: Posted Todayjob requisition id: R32346BeOne 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:*** Acts as line manager for study start up and trial monitoring staff (CRAs) in the country* Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development of direct reports.* Participate in selection for hiring and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.* Demonstrates a high level of clinical operations knowledge, organizational skills, project management and leadership competencies.* Adheres to ICH/GCP, assure clinical trial protocols are executed at clinical trial site in accordance to ICH guidelines and GCP, local regulations, and applicable SOPs.* Collaborate closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.* Supports start-up and provide local expertise.**Essential Functions of the Job:*** Responsible for managing study start up and trial monitoring staff in accordance with BeOne’s policies and applicable regulations.* Participate in the selection for hiring new employees. Ensure that new employees are properly onboarded and trained to complete job responsibilities. Provide oversight for the execution of the training plan and training experiences, as applicable.* Manage the quality of assigned staff's clinical work through regular review and evaluation.* Provide country-specific study start-up expertise to study start-up team leads and project teams. Review study start-up document templates, drug labels, ICF, and other applicable documents.* Helps to develop and reviews site specific recruitment materials and tools.* Perform independent quality review of submission packages, submit package to EC and HA, if required.* Collaborates with Regional Clinical Operations Manager and clinical study sites to achieve timely and complete IRB/EC submissions, ensure TMF completeness and ensure successful delivery of country site commitments, i.e. achieving site activation and enrolment goals within planned timelines, as well as maintaining inspection readiness.* Contribute to feasibility, site identification, selection and evaluation.* Performs accompanied visits of CRAs to assess their performance. Review visits reports, follow-up on issue resolution and communicates with the rCOM on significant risk identified and action proposed.* Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.* Anticipate and identify site issues; propose CAPAs; identify gaps and utilize opportunities, as required. Constantly strive for operating excellence, question status-quo and promote innovation.* Contributes to Clinical Operations strategy and performance against key metrics, identifying areas of improvements and propose solutions**Supervisory Responsibilities:*** Mentor and manage junior staff and Clinical Research Associates* Acts as the escalation point person for CRA(s) with site related issues and concerns* Conduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback as well as oversight of subordinate team’s performance**Education Required:*** Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* Minimum of 5-7 years progressive experience in clinical operations within the biotech/ pharmaceutical sector within Italy* Prior clinical trial experience including experience in a management/leadership capacity experience in oncology is highly recommended**Computer Skills:** Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook**Other Qualifications:*** Ability to work independently and effectively handle multiple priorities in a fast-paced environment* Minimum of 5-7 years progressive experience in clinical operations, preferably including at least 2 years of line management in the pharmaceutical or CRO industry* Excellent interpersonal skills, strong organizational skills* Fluent in English (writing and speaking)Travel: up to 30-40%Global CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.* Fosters Teamwork* Provides and Solicits Honest and Actionable Feedback* Self-Awareness* Acts Inclusively* Demonstrates Initiative* Entrepreneurial Mindset* Continuous Learning* Embraces Change* Results-Oriented* Analytical Thinking/Data Analysis* Financial Excellence* Communicates with ClarityWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.