Clinical Project Manager

Proclinical is currently seeking a Clinical Project Manager for a biotechnical company located in New York. Successful candidate will contribute to the execution of gene therapy projects per development plan, from initiation through to closeout. Candidate will also ensure that all clinical study management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices.

Job Responsibilities:

• Supporting project team members to be compliant with current ethical and regulatory guidelines and requirements.
• Supporting budget negotiation and trial agreements with sites.
• Managing program budget and providing input.
• Developing project management plan and being responsible for cross functional project meetings.
• Liaising with data management team and external vendors - ensuring data is reported accurately and in a timely manner for the responsible program.
• Managing outsourced vendor oversight and invoicing.
• Handling the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project.
• Reviewing and managing any oversight of TMF and clinical operations inspection readiness.
• Collaborating internally and externally to ensure clinical milestones are achieved and ensuring issues and obstacles are managed accordingly.
• Mitigating clinical risk by problem solving and contingency plan development.
• Overseeing site and team communications and compliance with regulations and SOPs.
• Managing and supporting quality assurance.
• Supervising the implementation of corrective action plans.
• Overseeing activities outsourced to CRO.
• Identifying and contributing to compilation and delivery of study associated documentation.
• Reviewing trial data and procedures ensuring good quality data.
• Establishing and maintaining good communication and relations with stakeholders in the clinical programs.
• Contributing to the development of the clinical quality management system by developing and reviewing Standard Operating Procedures and supporting documents.
• Assisting and participating in audits and inspections.

Skills and Requirements

• BA/BS (or equivalent) in a Biological Science discipline.
• 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
• 2+ years of clinical trial management experience in a commercial setting.
• Excellent oral and written communication skills.
• Strong work ethic.
• Resourceful and able to creatively solve problems.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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