Clinical Research Manager

Clinical Project Manager

Barrington James are fortunate enough to be partnered with a small sized CRO who are looking for their next Project Manager to help drive their vision of expansion across Europe. They have seen huge amounts of growth over the past decade and are hiring for Project Managers to come in to the business to drive all aspects of the project management process from initiation, planning, execution, control and closure.

This is an ideal opportunity for someone who is looking to progress further and take their career to the next step.

My clients are one of the the world’s leading independent, full-service ophthalmic clinical research and product development firm with offices in the United States, the United Kingdom and Japan. They support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market.

Responsibilities

• Manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s).
• Drives all aspects of the project management process from initiation, planning, execution, control and closure.
• Manages all aspects of a clinical trial proactively.
• Develops enrollment projection, timeline, and hours required for the study as part of the overall study budget.
• Responsible for maintaining the ongoing timelines for each study, and uses these timelines to track and manage a study’s progress.
• Responsible for ongoing budget tracking and progress reviews for each study.
• Oversee and/or review of the development and writing of ICF, source documents and eCRFs, and tracks them to completion.
• Review of the clinical protocol for operational considerations.
• Writes or oversees the development and writing of all study plans.
• Reviews study-related materials created by the Monitoring and Data Management Groups (e.g. study training manuals, monitoring plan, data management plan, Statistical Analysis Plan).
• Ensures review of Clinical Trial Master File for completeness.
• Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management).
• Responsible for periodic (weekly, or as needed) clinical trial team meetings both internal and with the Sponsor.
• Reviews study metrics for performance and quality with the team and management.
• Informs all functional leads of deliverables and timeline, project developments and insures completion according to timelines. Ensures all respective study functional leads provide deliverables on time (e.g. query generation and resolution, data base lock, study report).
• Manage and coordinate all vendors involved in the clinical trials, e.g. central labs, reading centers
• Prepares high-quality reports (financial, project, etc.) for management on program status and issues.
• Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs.
• Negotiates and manages competing priorities across multiple functional areas.
• Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs.
• Develops strong relationships with current and prospective clients to generate new and/or add-on business opportunities. Supports business development by participation in bid defense or capabilities presentations.
• Serves as a team leader and actively line manages and mentors other project management and clinical monitoring staff. Facilitates team building and communication.
• May represent Ora at professional meetings or seminars.

Other Requirements

• BS or MS in a Life Science, 3+ years of industry clinical project management experience, 5+ years of industry clinical experience.