Clinical Project Manager

Hobson Prior are looking for a Clinical Project Manager to join a clinical-stage gene therapy company on a permanent basis in New York.

Job Responsibilities:

• Support project team members to be compliant with current ethical and regulatory guidelines and requirements.
• Support budget negotiation and trial agreements with sites.
• Oversee program budget and provide input.
• Develop project management plan and be responsible for cross functional project meetings
• Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible program.
• Responsible for outsourced vendor management oversight and invoicing.
• In charge of the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project.
• Responsible for oversight of TMF review and upkeep for clinical operations inspection readiness.
• Work together internally and externally to ensure clinical milestones are achieved and to ensure issues are managed accordingly.
• Alleviate clinical risk by problem solving and contingency plan development.
• Oversee communications and compliance with regards to regulations and SOPs.
• Supervise and support quality assurance.
• Manage the implementation of corrective action plans.
• Oversee activities outsourced to CRO.
• Identify and contribute to gathering and delivery of study related documentation (protocols, IB, ICF, etc).
• Regularly review trial data and procedures guaranteeing good quality data.
• Establish and uphold good communication and relations with others in the clinical programmes including investigators, CROs, and regulatory consultants.
• Contribute to the expansion of the clinical quality management system through the development and review of SOP's and supporting documents.
• Aid and participate in audits and inspections.

Key Skills:

• Able to maintain ownership throughout assigned work by using initiative, strong decision-making whilst maintaining flexibility.
• Being well organised, able to effectively prioritise workload and multi-task.
• Outstanding and professional communication skills, both written and verbal.
• Ability for working independently as well as in a team environment under time and resource pressures.
• Understanding of the principles of ICH GCP and regulatory requirements in both the EU and US.
• Previous line management and supervision experience.

Requirements:

• Educated to Degree level (or equivalent) in a Biological Science discipline.
• Minimum of 5 years clinical trial management experience to include trials of an advanced medicinal product.
• At least 2 years of clinical trial management experience in a commercial setting.
• Experience working within a small biotech would be advantageous.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.