Clinical Research Associate Line Manager

Clinical Research Associate Line Manager

BeiGene

Remote, Poland

General Description:

• Acts as line manager for study start up and trial monitoring staff (including SSUS, 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, organizational 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 of the job:

• Responsible for managing study start up and trial monitoring staff in accordance with BeiGene’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.
• Perform independent quality review of submission packages, submit package to EC and HA, if required.
• 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 rCSM 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.

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.

Education Required:

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

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Poland      Clinical Research      Remote      BeiGene