Skip to main content

This job has expired

Clinical Trial Manager II - UK

Employer
Labcorp
Location
Maidenhead, United Kingdom
Salary
Competitive
Start date
27 Oct 2021
Closing date
4 Nov 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


- Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure.
• Serves as the main point of contact at a country level for internal and external stakeholders

• Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
• Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
• Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
• Assessment and set up the of vendors during study start up period (locally)
• Investigator Meeting participation and preparation
• Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
• Validation of study related materials (i.e. protocol, ICF, patient material)
• Responsible for preparing country specific documents (e.g. global country specific amendment)
• Prepares materials for Site Initiation Visits
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow up. Ensures timelines are met.
• Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities
• Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
• Lead study team meetings locally
• Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
• Management of Site relationships (includes CRO related issues)
• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
• May perform site closure activities, including post-close out
• May act as point of contact for Sites
• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances
Education/Qualifications:
Bachelor's or Master's degree in Life Sciences or equivalent
Experience:
Must Have
• Minimum qualifications posted above
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
• Demonstrated organizational and planning skills and independent decision-making ability
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Ability of critical thinking and risk analysis
• Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
• Skilled in the use of technology
• Strong English (oral & written) and local language capabilities in (Ex-US

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert