Principal CRA – Lead Monitor (mwd)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
About Us
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier cleaner and safer. Through our PPD clinical research services we support clinical trials in more than 100 countries delivering laboratory digital and decentralized solutions that help bring life-changing therapies to patients faster.
Our global Clinical Operations teams provide end-to-end clinical trial support from study start-up through close-out across commercial and government-sponsored studies.
Why Join Thermo Fisher Scientific / PPD
Work on high-quality global clinical trials across diverse therapeutic areas
Be part of a stable well-established organization with long-term career opportunities
Strong collaboration with experienced CTMs and project teams
Clear development pathways (e.g. Lead CRA CTM)
Flexible working models that support work-life balance
Permanent employment
Full-time (40 hours/week) or Part-time (32 hours/week) options available
About the Role
We are seeking a highly experienced Principal Clinical Research Associate (CRA) to lead and coordinate all aspects of clinical monitoring and site management for complex clinical trials. Acting as a subject-matter expert and site process specialist you will ensure trials are conducted in accordance with the approved protocol ICH-GCP applicable regulatory requirements and internal SOPsensuring subject safety data integrity and continuous audit readiness.
In this principal-level role you will manage complex and high-risk studies across multiple sponsor and monitoring models (e.g. FSO FSP government-sponsored research). You will serve as a key escalation point for sites and project teams take a leadership role on assigned studies and actively contribute to the mentoring and development of junior and senior CRAs alike.
What Youll Do
Principal-Level Clinical Monitoring & Oversight
Lead monitoring activities for complex high-risk or strategically important clinical trials using a risk-based monitoring approach
Independently conduct on-site and remote monitoring visits in line with approved monitoring plans
Perform and oversee SDR SDV and CRF review ensuring the highest standards of data accuracy and integrity
Evaluate investigational product accountability through physical inventory and records review
Ensure essential documents are complete inspection-ready and compliant with ICH-GCP and applicable German/EU regulations
Lead site initiation maintenance and close-out activities providing expert guidance and recommendations
Quality Risk & Issue Management
Apply advanced root cause analysis (RCA) critical thinking and problem-solving methodologies to identify systemic site issues
Strategic Project & Stakeholder Collaboration
Serve as a trusted partner to investigative sites sponsors and internal project teams
Identify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM)
Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where required
Participate in investigator meetings and support investigator identification and feasibility activities
Support investigator payment processes and trial financial oversight as applicable
Leadership Mentorship & Process Improvement
Actively mentor coach and support the development of junior and senior CRAs
Contribute to project-specific and functional training initiatives
Identify opportunities for process optimization and drive implementation of improvements
Provide expert input into monitoring strategies and clinical operations best practices
Administrative & Operational Responsibilities
Maintain timely and accurate completion of timesheets expense reports and required documentation
Maintain frequent communication with sites between visits to ensure ongoing compliance and issue resolution
Drive corrective and preventive actions (CAPAs) to resolution and proactively mitigate risk
Author high-quality monitoring reports and follow-up correspondence in a timely manner
Act as a key escalation point for significant site issues protocol deviations and compliance risks
Support and lead activities related to audits inspections and regulatory inquiries
Education & Experience
Bachelors degree in a life sciences related field or equivalent qualification
Minimum 5 years of experience as a Clinical Research Associate / Monitor
Valid drivers license
Full right to work in Germany
Fluency in German and English (C1 level) interviews will be conducted in German
Knowledge Skills & Abilities
Strong clinical monitoring skills with hands-on RBM experience
Excellent understanding and application of ICH-GCP and applicable regulations
Solid therapeutic area knowledge and medical terminology
Well-developed critical thinking problem-solving and root cause analysis skills
Strong written and verbal communication skills with medical professionals
High attention to detail and strong organizational skills
Ability to work independently while contributing effectively to cross-functional teams
Flexibility and adaptability in a dynamic project environment
Proficiency in Microsoft Office and ability to learn clinical systems (e.g. CTMS)
Locations: Home-based or hybrid anywhere in Germany
FTE: Full-time (40 hrs/week) or Part-time 80% (32 hrs/week)
Contract: Permanent
Travel: Approximately 5075% (study-dependent)
Severely disabled applicants with the same aptitude will be given preferential treatment.
Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt.
Required Experience:
Staff IC
Key Skills
About Company
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