[Hiring] Associate Clinical Research Manager @BeiGene

Role Description

The Associate CRM oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH-GCP, local regulations, and company SOPs, and maintain quality across clinical trials. As a line manager, this role leads a team to achieve organizational goals and ensure high performance by providing guidance, support, and development opportunities while promoting a positive team culture.

Essential Functions of the Job

• Team Resource Allocation & Performance:
  • Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables.
  • Ensure CRAs have the required level of monitoring knowledge and skills to successfully perform required activities with high quality to meet study deliverables.
  • Manage and address CRA performance and quality indicators in accordance with ICH-GCP, SOPs, and local regulations.
  • Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation.
• Quality and Compliance:
  • Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH-GCP Guidelines, and Good Clinical Practices.
  • Support study/site milestone delivery in collaboration with cross-functional teams.
  • Responsible for execution of assessment visits and accompanied visits (where required) to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies.
  • Contribute to process optimization initiatives and manage risk escalation and resolution.
  • Support site audits/inspections/Site Compliance Visits (SCV) and ensure corrective action and follow-up for identified issues.

Supervisory Responsibilities

• Recruitment and Onboarding: Performs recruiting and hiring activities, along with onboarding new team members to ensure alignment with team objectives and culture.
• Task Assignment: Assign tasks based on individual strengths and team objectives, ensuring optimal productivity.
• Support and Resource Provision: Support team members by providing necessary resources to help them effectively perform their roles.
• Communication and Collaboration: Encourage open communication and collaboration within the team and with other functions, including acting as a point of contact for issue escalation and feedback where required.
• Performance Evaluation: Conduct regular performance evaluations and provide constructive feedback to promote continuous improvement.
• Mentoring and Development: Lead and mentor team members, fostering an environment of growth and development.
• Issue Resolution: Address any personnel issues promptly and fairly to maintain a positive work environment.
• Career Development Support: Support team members in identifying and pursuing professional development opportunities.

Qualifications

• Fluent in written and verbal English.
• Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field.
• Thorough understanding of the drug development process, including expert knowledge of international standards (ICH-GCP) and health authority requirements.
• Understanding of all aspects of monitoring and trial execution, with previous experience as a CRA preferred.
• Excellent interpersonal skills, strong organizational and effective written and verbal communication skills.
• Experience in Oncology is highly recommended.
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

Requirements

• Be adaptable to business trips as required per business need; require valid driver’s license in applicable countries.
• Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred.

Benefits

• Medical, Dental, Vision.
• 401(k), FSA/HSA.
• Life Insurance.
• Paid Time Off.
• Wellness programs.

Salary Range

$105,800.00 - $140,800.00 annually. BeOne 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.

Company Description

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.