Senior/Clinical Trial Manager - Europe (Remote) - Cardiovascular, NASH
- Employer
- Worldwide Clinical Trials
- Location
- United Kingdom;Homeworking
- Salary
- Competitive
- Start date
- 8 Dec 2021
- Closing date
- 7 Jan 2022
View more
- Discipline
- Clinical Research, Clinical Research Associate
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
The selected candidate is responsible for ensuring site qualification, initiation, interim monitoring, site management, and study close-out activities for studies in accordance with the study protocol and study plan. In addition, the CTM ensures overall quality and timeliness of clinical deliverables for assigned programs and/or region.
Cardiovascular and NASH experience is required.
Essential Functions:
- Actively participate in the implementation and execution of clinical trial activities from study planning through closure; ensure compliance with the clinical monitoring plan
- Provide leadership and direction to clinical site management team members from study start through closure; training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and Sponsor as needed
- Point of escalation for clinical site management and investigator sites
- Draft (and finalize) the Clinical Monitoring Plan (CMP) and customization of Worldwide Clinical Trial monitoring visit report/letter templates, site/monitoring tools
- 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.
- Track and reports to PM on compliance, trends and study metrics; responsible 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
- Support the PM in ensuring the CRA team is staffed to meet the monitoring demands of the project or program in compliance with the approved budget and CMP; support 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 enrollment stays on target.
- Follow up with CRAs regarding visits schedules, outstanding trip reports and follow up letters; review/finalize trip reports according to SOPs, expectations and as outlined in the annotated report
- May perform site qualification, initiation, interim monitoring, and/or closeout site visits as needed
- Represent clinical site management on sponsor and other relevant study team calls and may represent the Company as the primary contact on projects
- Conduct occasional co-visits for a specific study to ensure the quality of the site, of the CRA work and of the study procedures
Other skills and abilities:
- 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
- Excellent oral and written communication, organizational, problem-solving and interpersonal skills
- Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
- Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
- Proficiency with IxRS, EDC systems
Requirements:
- Bachelor Degree or Nursing Degree required and a minimum experience of 8 years as a Clinical Research Associate
- Must have previous experience as a Lead CRA, Clinical Operations Lead or Clinical Trial Manager
- Cardiovascular and NASH experience required
- Willingness to travel required up to 30%
- Valid current passport required
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Company
Find out more about working for our company
Brief Company Description;
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
- Website
- https://www.worldwide.com/
- Mini-site
- Worldwide Clinical Trials
- Telephone
- +44 115 956 7711
- Location
-
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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