Regional Clinical Study Manager - Oncology/ Solid Tumor

BeiGene, Ltd.; United States; Remote; USD 116,000 - 157,000; Full time

Job summary

An established industry player is seeking a Regional Clinical Study Manager to lead oncology studies. This role is pivotal in ensuring study delivery meets quality standards and timelines while collaborating with key stakeholders. You will oversee regional operations, manage budgets, and ensure compliance with regulations. The position offers a unique opportunity to make a significant impact in the fight against cancer, working alongside a passionate team dedicated to improving patient outcomes. If you are a motivated leader with a strong background in clinical research, this opportunity is perfect for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Time Off

Wellness Programs

Employee Stock Purchase Plan

Annual Bonus Plan

Qualifications

• 4+ years of experience in clinical research within biotech, pharma, or CRO.
• Proven experience as team lead in clinical functions.

Responsibilities

• Accountable for regional study delivery within timelines and budget.
• Leads the regional clinical operations team and external vendors.

Skills

Clinical Research

Team Leadership

Project Management

Analytical Thinking

Collaboration

Education

Bachelor’s Degree in a scientific or healthcare discipline

Higher Degree preferred

Tools

MS Office

Project Planning Applications

Job description

Regional Clinical Study Manager - Oncology/ Solid Tumor

Regional Clinical Study Manager - Oncology/ Solid Tumor

Apply locations Remote (US) time type Full time posted on Posted 30+ Days Ago job requisition id R23565

BeiGene 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.

Position Summary:

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget.
• Leads the regional clinical operations team (including oversight of external partners working on the 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 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.

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 the 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 colleagues to ensure cross-team, site learnings, and best practices are shared.
• Leads improvements and partners with CST members to enhance the 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 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.

Computer Skills:

MS Office, Project Planning Applications.

Other 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 team lead in clinical functions.
• Experience as CRA is preferred.

Travel:

Travel might be required as per business need.

Education Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred.

*exceptions might be made for candidates with relevant clinical operations experience.

BeiGene 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.

• 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

Salary Range: $116,300.00 - $156,300.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.