The Project Manager will have responsibility for the day-to-day management and completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget under the guidance of the Exec. Director, PM and Client Services

Main Tasks And Responsibilities

• Maintain contact with the Sponsor from project initiation to operational close out for allocated studies
• Lead the internal project team to ensure timely project communication and delivery throughout the life of the project for allocated studies
• Monitoring and control of allocated project progress to time/quality/cost
• Invoicing and debtor management
• Management of third party and internal suppliers as required
• Documentation of study related communication e.g. minutes, t-cons, risk registers & issue logs in a timely manner
• Generation, review and approval of appropriate study-related documentation and reports in line with SOP requirements
• Chair lessons learned meetings as appropriate
• Work with the internal team to identify and have mitigation strategies for project specific risk
• Management of study execution to ensure regulatory approvals, pharmaceutical development work, recruitment and screening of volunteers, clinical manufacturing, clinical operations and data sciences activities are delivered for customer
• Management of close out of studies to ensure data queries, post-study reporting to the regulatory authorities, scientific review meetings and archiving are completed in a timely manner for allocated studies
• Preparation of participant information and consent forms and management of the review process
• Tracking of allocated projects and issues in MS Project on a real time basis
• Oversight of the Investigator Site File and Trial Master File as required
• Application of lessons learned from previous studies to ensure continuous improvement in delivery
• Host Sponsor monitoring visits as required
• Oversight of data query resolution
• Support other aspects of the business as needed
  
  

Qualifications And Experience Required For Competent Performance

• Minimum Degree qualification or equivalent
• At least 2 years experience of working in a clinical research/manufacturing environment
• Ability to communicate effectively with internal and sponsor team