General Description:The role may be a combination, in variable proportions, of line management and operational responsibilities (CTMA type tasks). - Line manage Clinical Trial Management Associate (CTMA) team members. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development of direct reports.
- Lead the selection, hiring and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
- Proactively seeks opportunities to participate and lead process improvements, best practices and to share lessons learned with team and other colleagues.
- Demonstrates advanced clinical operations knowledge and has strong organizational skills.
- Leads study teams with Clinical Operations tasks, and/or support compilation and quality of the trial master file (eTMF).
- Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.
Essential Functions of the job: Line Management - Conduct regular 1:1s with direct reports (may be a group of BeiGene internal CTMAs and FSP CTMAs) to assess workload, provide feedback, track goals, development (direct development discussions in case of BeiGene internal CTMAs, development discussions & collaboration with FSP CRO LMs in case of FSP CTMAs). For the FSP CTMAs, meet regularly with FSP CRO LM(s) to ensure timely feedback.
- Conduct regular performance reviews with direct reports (e.g., mid-year, end-year).
- Interview and onboard new hires; ensure ongoing team members training, and adhesion to internal processes and SOPs.
- Promote a quality mindset in the organization and support the implementation of risk management principles.
- Contribute to the resource allocation process by assigning the right person to the right study at the right point in time, while addressing both study and individual development needs
- Coordinate and balance team members' workload, regular review of their quality metrics, and reporting of findings as outlined by clinical operations management.
- Understand importance of activities and how they fit within drug development process; oversee appropriate and effective delegation of tasks inside the team.
- Manage and maintain CTMA resourcing tools.
- Ensure operational excellence; question status-quo and translate it into actionable plans; promote innovation and translate it into implementable initiatives.
- Demonstrate master of skills required to support clinical trials.
- Contribute to (or leads part of) Clinical Operations strategy and performance against key metrics.
- Contribute to (or leads) the development of local/global process improvement activities.
- Participate in and help facilitate CTMA formal group discussions.
- Other duties as assigned.
Clinical Operations support to study teams: Provide support to cross-functional clinical study teams from start-up through close-out.
- Assist in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking).
- Preparation and documentation of internal and external meetings by preparing agendas and minutes.
- Maintaining clinical operations tools (e.g., CTMS, EDC, IRT) as instructed by the study lead.
- Contribute to setup, maintenance and close out of eTMF.
- Other duties as assigned.
Computer Skills: MS Office, Project Planning Applications
Other Qualifications: - Solid leadership and management experience either as direct line manager or as cross functional team lead.
- Strong written and verbal communication skills.
- Exercises sound judgement and discretion in matters of significance.
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment.
- Excellent interpersonal skills, strong organizational skills and ability to influence and lead.
Travel: Travel might be required as per business need.
Salary Range: $136,400.00 - $181,400.00 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. 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 BeOne Medicines 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.
