Regional Clinical Study Manager

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.

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English required. Spanish is a plus

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Sao Paulo Hybrid (2 to 3 days per week in the office)

General Description:

The Regional Clinical Study Manager (CSM) leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities. Works to ensure adherence to a standardized approach to clinical trial management.

Manages clinical trial projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters. Exhibits a strong understanding of methodologies and approaches, ensures alignment of clinical project goals with Clinical Operations program objectives.

People management which includes performance oversight and development, quarterly check-ins, year-end performance reviews and mentoring of team members.

Essential Functions:

Quality

Ensures that TMF for assigned clinical trial(s) is created, maintained, monitored, and closed out on a timely basis

Ensures site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are being adhered to

Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance

Manages Central Lab and ancillary vendors selection, set-up, conduct, and close-out for BeiGene studies.

Oversees and/or delegates the management and oversight of study vendors (CRO) to ensure that BeiGene’s clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial deliverables and performance goals are met.

Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs

Timelines

Escalation point person to Clinical Program Lead and Program Management Lead when necessary.

Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks

Ensures accurate and comprehensive completion of documents needed for Health Authority submissions by working with Regulatory Affairs to establish timeframes for submissions and ensure clarity of documentation required

Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process

Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites

Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts

Budget

Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners

Oversees the administration of invoice reconciliation, scoping, and change orders, for clinical trial operations

Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts

Participates in clinical trial scenario planning (estimates time and cost)

Planning/Leading

Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close-out to ensure both internal and external deliverables are on time and on budget

Ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity

Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving

Proactively identifies, negotiates and brokers solutions to clinical study issues that may arise

Delegates and oversees the management of certain aspects of project management to junior staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters

Minimum Requirements – Education and Experience:

Bachelor’s degree in a scientific or healthcare discipline required;

Masters degree or higher preferred

5+ years of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical sector or CRO industry.

Other Experience:

Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.

Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.

Proficient written and verbal communication skills.

Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.

Management experience of CROs, Vendors and Consultants preferred.

Therapeutic or medical knowledge preferred

Regulatory authority inspection experience a plus

Strong written and verbal communication skills.

Supervisory Responsibilities:

Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans

Conduct quarterly check-ins and year end performance appraisals for direct reports which includes providing ongoing and constructive feedback

Travel: Up to 10 - 15%

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

#LI-Remote

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