Clinical Trial Manager, CNS in Europe

Multiple Locations: United Kingdom • Serbia • Poland • Italy • Spain

Notice

This position is no longer open.

Requisition Number: 2487

Position Title: Clinical Trial Manager

External Description:

LOCATION: Eastern and Western Europe (home-based)

TA: CNS, Neurology

SUMMARY: Responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff within a geographic region. Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may act as Report Reviewer.

RESPONSIBILITIES:

  • Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes
  • Provide leadership and direction to clinical site management team members from study start through to closure
  • Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to:
  • Primary SM Sponsor contact
  • Investigator and Bid Defense Meeting
  • Internal and External study team calls
  • Project specific Audits / Inspections
  • Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities
  • Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP)
  • Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters
  • Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP.
  • Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed
  • Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target
  • Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality
  • Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed
  • Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready
  • Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed
  • Review/finalize trip reports according to Worldwide SOPs and expectations
  • May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed
  • Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed
  • Proactively identify and mitigate risks
  • May represent site management as primary contact on projects
  • Conduct co-visits where required to ensure quality of site, the CRA work and study procedures.

OTHER SKILLS AND ABILITIES:

  • Excellent interpersonal, oral and written communication skills in English
  • Excellent planning and organizational skills with effective time management
  • Excellent presentation skills
  • Flexibility to change
  • Ability to manage multiple and varied tasks with enthusiasm
  • Ability to negotiate and influence with diplomacy in order to achieve results
  • Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified
  • Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision
  • Ability to lead and motivate a team remotely
  • Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
  • Strong customer focus, ability to interact professionally within a sponsor contact
  • Extensive understanding of clinical research principles and process
  • Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements
  • Experience in the study therapeutic indication/area
  • Thorough understanding of standard operating procedures
  • Proficient knowledge of Microsoft Office, eCRF, IVRS packages
  • Proficiency with IxRS, CTMS and EDC systems

REQUIREMENTS:

  • Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR
  • Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate
  • Minimum 1-2 years experience functioning as CTM/LCRA (or equivalent) with CNS and Neurology TA; supporting main CTM and coordinating clinical operations activities
  • Travel required
  • Valid current passport required
  • Driving license required

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City:

State: Nottinghamshire

Employment Type: Regular

Community / Marketing Title: Clinical Trial Manager, CNS in Europe

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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