Clinical Research Manager

BeiGene, Ltd.; Deutschland; Remote; EUR 83.000 - 104.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Zusammenfassung

BeOne seeks an experienced clinical operations leader to manage trial monitoring staff in Germany, ensuring study start-up, site activation, and enrolment goals within timelines. You will guide performance, onboard new hires, and uphold ICH/GCP standards across all sites.

The role requires a Bachelor's or higher in a scientific field, 5-7 years in clinical operations, and fluent German and English. Oncology experience is highly recommended, with up to 30-40% travel.

Qualifikationen

• Bachelor's degree (or equivalent) in a scientific/medical discipline.
• 5-7 years of progressive experience in clinical operations.
• Experience in oncology is highly recommended.

Aufgaben

• Mentor and manage junior staff and Clinical Research Associates (CRAs).
• Plan, assign, and direct work; assess performance and develop staff.
• Oversee study start-up, TMF, site activation, and enrolment timelines.
• Ensure compliance with ICH/GCP, local regulations, and SOPs.

Kenntnisse

German & English fluency

Line management

Interpersonal skills

Organizational skills

Communication skills

Ausbildung

Bachelor's degree or higher in scientific/medical field

Tools

MS Word

MS Excel

MS Project

MS PowerPoint

Outlook

Jobbeschreibung

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

Acts as line manager for trial monitoring staff (CRAs) in the given 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, organisational skills, project management and leadership competencies. Adheres to ICH/GCP, assure clinical trial protocols are executed at clinical trial sites 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

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. 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.

Minimum Requirements – Education and Experience

Bachelor's degree (or equivalent) or higher in a scientific, medical or healthcare discipline. Minimum 5-7 years progressive experience in clinical operations within the biotech/ pharmaceutical sector. Prior clinical trial experience including experience in a management/leadership capacity. Experience in oncology is highly recommended.

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 German & English (writing and speaking).

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.

Travel

up to 30-40%

Computer Skills

Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook.

Salary Range

83,400.00 EUR - 104,300.00 EUR

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

Equal Opportunity Employer

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.

About BeOne

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland.

China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.

Values

• Patients First
• Driving Excellence
• Bold Ingenuity
• Collaborative Spirit