Clinical Operations Lead (Clinical Trial Manager) at Alimentiv

berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 26

Salary

75000.0

Posted On

22 Sep, 26

Experience

18 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Healthcare & Life Sciences

Description

About the job

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

Project Oversight

Overall oversight of (a group of) regional 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 the satisfactory performance and compliance with standards mentioned above
May support 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 project requirements and 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. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review
May be required to manage/oversee investigator sites including 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 Study Sponsor to provide status updates on country and site progress
Provide operational support and guidance to the monitoring team throughout 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. Escalates to PM and other functions as appropriate
Support line managers by providing status updates on utilization 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 their 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 clinical project team
Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits

Qualifications

College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading

Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

Other

Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation
Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills
Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized
Demonstrate the 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 in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com

PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

+ Bonus

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities