Requisition ID 2024-14222

Job Location(s)
Berlin (Germany)

Languages Required
English

Company
Cook Medical Europe Ltd

Position Type
Full Time

Category
Clinical

Education
Bachelor's Degree

Overview
This position is responsible for setting-up and overseeing the CRAs in EMEA and assuring collaboration on global monitoring initiatives.

Responsibilities

Lead the team of external CRAs in EMEA
Continuously assess CRA resources needed for ongoing and future studies
Work with various vendors to identify and hire sufficiently experienced CRAs
Attend study meetings (internal and external), as needed
Support development and apply practical training program for new CRAs
Ensure CRAs complete and adequately document role-based and any study-related trainings
Overlook CRA performance and provide timely and accurate feedback to the CRAs on a regular basis
Perform co-monitoring visits with CRAs as needed to ensure monitoring process, protocol and procedures are correctly understood
Develop study-specific monitoring plans and provide input to global monitoring plans
Through close collaboration with Director Global Monitoring, help ensuring global alignment with regard to monitoring and global sharing of best practices
Support Director Global Monitoring with development of remote and central monitoring strategies and implement them locally
Serve as mentor for new external CRAs as well as for new internal EMEA team members with regards to monitoring topics and serve as point of contact for day-to-day questions
Review Monitoring reports and follow-up letters
Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA CFR, ISO14155, ICH-GCP, EU MDR) and country-specific regulatory requirements that impact clinical studies
Review and provide input to clinical study-related documents, and training materials (e.g., CIP, IB, CRF Specifications, Study-specific IC Template, Progress Report, Training Plan, Audit Plan, Monitoring Plan, Clinical Study Overview Presentation)
Participate in external meetings, e.g., in RC or Investigator meetings, medical conferences
Assist in the preparation for site audits and inspections and in responding to any findings
Develop organizational tools such as Q&A lists for monitoring-specific topics
Participate and provide input to global Monitoring calls and distribute info as applicable to CRAs
Support the study team in resolving quality issues linked to monitoring deliverables
Perform spot checks of TMF documentation or any other document/activity

Qualifications
Educational Background:

Project Management and Monitor Manager experience. Background preferably in a life science, nursing, pharmacy related field or similar experience within science, healthcare or quality;
Proven record and at least 10 years of experience as CRA in, e.g., study start up activities, monitoring activities, insight into project management, and/or 3 years of experience as lead CRA or 2 years of experience as Monitoring Manager;
Knowledge of applicable international standards and other regulatory requirements that may impact clinical studies.

Personal qualifications:

Able to lead and motivate with a positive mind set;
Able to see studies from the HCPs’, patients’ and sites’ perspective;
Conscientious, influential person with an outstanding work ethic and strong personal discipline;
Willing and capable to handle multiple sites/studies/responsibilities;
Sufficiently assertive to deal with confrontational situations;
Excellent organizational, leadership and problem-solving skills;
Highly self-motivated;
Excellent written, listening, and verbal communication skills;
Able and desiring to work in a collegial team atmosphere; including communicating and working constructively with colleagues;
Willing and able to travel up to 80%.

Monitoring Manager EMEA