Clinical Operations Lead
Location: Düsseldorf, North Rhine-Westphalia, Germany
Employment type: Full-time
This range is provided by Alimentiv. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Responsibilities
Project Oversight
* Overall oversight of a group of regional Clinical Research Associates (CRAs) to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines
* Monitoring support visits (Co‑monitoring), per project requirements, to aid the site/CRA in satisfactory performance and compliance with the above standards
* May support the clinical project team by providing oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations, etc.)
* Oversee regional startup and feasibility activities
* Assist in vendor management activities as required per project
* Perform review of visit reports for quality, compliance and appropriate site management
* Assure compliance with high‑quality and timely project deliverables according to the monitoring plan
* Proactive management of site and country performance (recruitment, data collection, document collection, TMF review, etc.) and inform clinical project team on progress
* Contribute to financial project management processes as applicable such as revenue recognition, site payments and site pass‑through expense reviews
* May be required to manage/oversee investigator sites and CRA responsibilities, on a temporary or permanent basis
Project Liaison
* Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
* Attend meetings with the study sponsor to provide status updates on country and site progress
* Provide operational support and guidance to the monitoring team throughout the project
* Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study; ensures study‑specific training requirements are completed and documented
* First point of contact for regional CRAs for study‑specific questions and issues and escalates to PM and other functions as appropriate
* Support line managers by providing status updates on utilisation and performance of CRAs
* Liaise with line manager for assigning sites to CRAs following line‑manager allocation of a CRA resource to the project
* Conduct CRA assessment visits per departmental requirements to assess the performance of the CRA against monitoring responsibilities
Study Documents and Plans
* Develop training materials and study tools for sites and CRAs, including monitoring plans
* Develop and implement enrolment and recruitment strategies together with the clinical project team
* Develop presentation materials for and present at sponsor kickoff meetings, investigator meetings and sponsor calls (as needed) and prepare presentations for site qualification and site initiation visits
Qualifications
* College diploma/degree AND 7‑9 years related experience with continuous training and upgrading of knowledge/skills
* Undergraduate university degree (Bachelors or Honors Bachelors) AND 4‑6 years of experience with substantial ongoing job‑related training
Other Requirements
* Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP certification/designation
* Minimum of 3 years CRA experience, strong experience with EDC systems, proficiency with MS Office, strong written and verbal communication skills and highly effective interpersonal and organisational skills
* Proactive, detail‑oriented, task‑driven and highly organised
* Demonstrate critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and investigator responsibilities
* Demonstrated ability in report writing and strong ability to critically understand clinical research documents
* Ability to handle multiple tasks to meet deadlines in a dynamic environment
Working Conditions
* Home‑based
Accommodations for persons with disabilities are available on request. Please contact recruitment@alimentiv.com.
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