Life Science People are a strategic growth partner within the Life Science industry providing bespoke services to the life science community from SMEs through to blue-chip organisations and sourcing the best talent to make a tangible contribution to healthcare.
Do you want to work for a company that pushes boundaries, innovates, and invents? A company that are made up of pioneering experts, bright thinkers, dreamers, and doers. If so, then this may be the role for you…
The Global Clinical Trial Manager (CTM) remote role will work closely with PM and a CRA team to lead the delivery of site management clinical operations activities through the co-ordination of a team of Clinical staff globally.
As a Global Clinical Trial Manager your role will include:
- Actively participate in the implementation and execution of clinical trial activities from study planning through closure.
- Provide leadership and direction to clinical site management team members from study start through closure and be a point of escalation for clinical site management and investigator sites
- Drafting (and finalizing) the Clinical Monitoring Plan (CMP) and customization of company monitoring visit report/letter templates, site/monitoring tools
- May assist in the design and development of additional study related documents including (but not limited to) Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plan, etc.
- Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed.
- Track and reports to PM on compliance, trends and study metrics. Escalate issues and trends per study expectations.
- Supports the PM in the development of and implementation of recruitment strategy in countries and sites assigned. Leads the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrolment stays on target.
- Supports the PM in taking responsibility for the quality of the site data and addressing any identified needs with action plans with measurable metrics to ensure data cleaning is completed as specified.
- Formulates regional monitoring strategy and accountable for Forecasting of site visits w/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 SOPs, expectations and as outlined in the annotated report
- Follows up with CRAs regarding visits schedules, outstanding trip reports and follow up letters.
- Tracking status of reports & action items and ensures all project follow up letters are prepared and follow up actions from MV (any site visits) are closed
- May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed
- Provides a key role in problem solving and 1st in issue escalation regarding monitoring and site issues, with proposed solutions to Project Management team and Sponsor as needed
- Proactively identifies and mitigates risk
- Reports to the PM/GPL of a study within matrix management structure
- Represents clinical site management on sponsor and other relevant study team calls
- If budgeted conduct co-visits for specific study. The focus of the visit is to ensure quality of site, of the CRA work and of the study procedures.
Skills and Experience Required:
- Excellent interpersonal, oral and written communication skills, planning and organizational skills with effective time management and excellent presentation skills.
- Must be able to carry tasks out with minimal supervision due to working remotely.
- Ability to manage multiple and varied tasks with enthusiasm and to negotiate and influence with diplomacy in order to achieve results.
- Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified
- Ability to lead and motivate a team across locations and cultures
- 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
- Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
- Experience in the study therapeutic indication/area- NASH/ Hepatology
- Thorough understanding of standard operating procedures
- Proficiency in Microsoft Office and with IxRS, CTMS and EDC systems
- fluent in English
If this role interests you, then please apply now. You can submit your CV and cover letter highlighting your expertise as a Clinical Research Associate (CRA). We will send you a confirmation of acknowledgement, and please note feedback can take up to 2-3 weeks. Upon successful selection for an interview, the process will occur in the following stages:
First stage: This will be an initial screening call with a Life Science People representative.
Second Stage: You will be required to fill out a screening form, equivalent to a screening call.
Final stage: A video call with the hiring manager to go through your background and experience in relation to the role.
The Clinical Trial Manager role is a full-time permanent position, paying up a competitive salary & benefits package. You will be based remotely but will need to have a willingness to travel and thus a valid current passport will be required. Full details will be provided on application.
Apply today to not only make a difference to global health but to also excel your career!