Clinical Trial Lead

Catalyst Clinical Research

About The Position

As a Clinical Trial Manager you will be 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. You will be 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.

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, OR
Minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities
Travel required
Valid current passport required
Driving license required
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

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.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.