Clinical Programme Manager

Highly Competitive Salary
  1. Permanent
  2. Program Manager / Director
  3. United States
New York
Posting date: 11 Jul 2019
CR.NA.24321_1562858894

ProClinical is currently seeking a Clinical Program Manager for a biotechnical company located in New York. Successful candidate will support the planning and execution of gene therapy programs per development plan, from initiation through to closeout. Candidate will also ensure that all program management and deliverables are completed on time and within budget and in accordance with SOPs, policies and practices. The role will highlight any risks, slippages and obstacles with plans to mitigate any issues.

Job Responsibilities:

  • Contributing to the clinical and business project planning of Gene therapy programs.
  • Supporting the Clinical Research & Development projects, providing knowledge of all aspects of clinical development including supporting the day to day management of the clinical operations department.
  • Collaborating with stakeholders to ensure development milestones are achieved, and issues and obstacles are managed accordingly.
  • Supporting oversight of vendor management.
  • Supporting the communication of timelines across the team members to ensure efficient production, scheduling and delivery of projects.
  • Highlighting potential risks, and actual issues with quality, budget or timelines to the senior leadership team.
  • Providing oversight of project management plan development and assignments.
  • Providing oversight of Quality Management components of studies. Escalating potential risks, issues, findings and corrective actions as appropriate.
  • Supporting contract negotiations in relation to study matters.
  • Reporting to senior leadership on team performance against project expectations.
  • Facilitating continual improvements to internal processes to improve efficiency.
  • Participating in internal and external audits as planned and reporting non-conformances and recommendations for improvement.
  • Contributing to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
  • Overseeing preparation of study documents, procedures, manuals and study specific training
  • Supporting the oversight of the data transfer process at the vendor level.
  • Reviewing final program budgets.
  • Contributing to the development of key study documents such as clinical protocols, Investigator Brochures and Development Safety Update Reports.
  • Supporting the identification of vendors required to support a study.

Skills and Requirements

  • BA/BS (or equivalent) in a Biological Science discipline.
  • Proven experience of running projects in the gene therapy or advanced therapies arena.
  • Significant experience of working in a translational clinical research environment.
  • Proven strong project management experience.
  • Ability to work unsupervised and yet have strong interpersonal skills to influence; communicate and manage change.
  • Broad experience of business operations including Quality Management Systems, awareness of Expenditure and Processing of Requisitions.

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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