Regional Clinical Study Manager / Line Manager

BeiGene; Italia; Remoto; EUR 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

A leading biotech company in Italy is seeking a Clinical Operations Lead to manage regional study delivery and lead the clinical operations team. This role involves ensuring alignment with study goals and maintaining high-quality standards throughout the study lifecycle. The ideal candidate has over 4 years of clinical research experience and a Bachelor’s Degree in a scientific field. This position offers a full-time opportunity with the flexibility of remote work.

Competenze

• 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.
• Proven experience as a team lead in clinical functions.
• Experience as CRA is preferred.

Mansioni

• Accountable for regional study delivery and inspection readiness.
• Leads clinical operations team and resolves issues.
• Ensures alignment of regional deliverables with study goals.
• Manages clinical study operations from feasibility to closeout.

Conoscenze

Team leadership

Clinical research expertise

Analytical thinking

Project management

Communication skills

Formazione

Bachelor’s Degree in a scientific or healthcare discipline

Higher Degree preferred

Descrizione del lavoro

Overview

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.

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Essential Functions / Responsibilities

• 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.
• 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 the 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 the region in collaboration with feasibility managers, country heads, medical affairs and other stakeholders.
• Provides regional input on global study plans as required.
• Ensures timely availability of local adaptations of global study documents (e.g., informed consent forms), in collaboration with key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs.
• Accountable for submissions of studies in countries in the 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 QC’d 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.
• Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations; handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads.
• 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 & Resources

• Works with the sourcing team to select and manage regional study vendors.
• Manages regional study budgets.
• Works closely with Clinical Business Operations on investigator fees, site payment issues and patient travel reimbursement activities.
• Identifies and manages regional team resource needs and establishes contingency plans for key resources.
• Monitors regional resource utilization over study life cycle and liaises with functional managers as needed.

Supervisory Responsibilities

• Provides performance feedback on team members as required.
• Might mentor junior team members.

Education & Qualifications

• 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.
• Proven experience in clinical research including relevant experience as a team lead in clinical functions.
• Experience as CRA is preferred.
• Education: Bachelor’s Degree in a scientific or healthcare discipline required; Higher Degree preferred. Exceptions might be made for candidates with relevant clinical operations experience.

Travel

Travel might be required as per business need.

Global Competencies

When 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 Clarity

We 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.

Summary

• Location: Italy Remote
• Type: Full time