Clinical Study Manager

PE Global is currently recruiting for a Clinical Study Manager for a leading multi-national Biotech/Pharma client based in London.

This is an initial 6 month contract with strong possibility of extension for the right candidate.

This is being offered as a hybrid role with the candidate, ideally, attending the office every Wednesday with the rest of the team.

For assigned study(ies), the Clinical Study Manager is accountable for day-to-day study Operations study execution and related deliverables and is the primary point of contact within Global study operations for a study. Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the study team, vendors and CRO, and collaborating with cross-functional representatives to execute on study deliverables.

Role:

• Overall study execution oversight
  • Provide leadership, guidance and direction to study staff assigned to study
  • Responsible to facilitate and lead cross functional teams/subteams as needed. May serve as an agenda driven member of the Clinical Development Team (CDT)
  • Collaborate with cross-functional study members to execute on study deliverables
  • Ensure cross-functional development of key study plans (e.g., monitoring plan, data management plan, safety plan, etc.)
  • Proactively identify and communicate Clinical Operations and cross functional study risks and mitigations; align with cross-functional Study Execution Team on overall Risk Mitigation Plan
  • Identify, manage, and escalate study risks, issues and opportunities that impact timeline, quality, and budget
  • Provide regular study quality and progress updates to key stakeholders as needed; monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate
  • Collaborate with other Study Managers to ensure creation, consistency, and maintenance of the various study plans within a program
  • Collaborate with line managers of CTS staff to support team member productivity and career growth
• Study protocol and Informed Consent Form (ICF) development
• Study resource planning
• Study timelines
• Vendor oversight
• Study start-up – site selection and activation
• Drug / Investigational Product (IP)
• Study quality
• Study budget oversight
• Recruitment, enrolment, and monitoring oversight
• Study outcome and data deliverables
• Study closeout
• Insurance
• Program-wide initiatives
  • Lead or participate in study-specific projects that have a wider program impact
  • Collaborate with study managers/cross-functional team members to identify and correct inconsistencies and implement consistent and best practices

Requirements:

• Study Management and Execution experience
• Compliance and Quality Data Analysis and Interpretation experience  
• Drug Development and Study Design experience 
• Product and Therapeutic Area Knowledge 
• Decision Making, Strategic Thinking, and Problem Solving skills
• Influence and Organizational Awareness
• Agility and Proactivity 
• Leadership skills
• Communication and Collaboration skills 
• Data Analysis and Interpretation experience

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***