Senior Clinical Research Associates (experienced) - Germany at Thermo Fisher Scientific

Munich, Bavaria, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Minimum 2+ years of experience as a CRA (Senior CRA I/II)
Experienced CRA only
Ability to work in Germany (near Frankfurt or open across all locations; fully homebased, fully office-based in Munich or Karlsruhe, or hybrid)
Availability for full-time (40 hours/week) or 80% FTE permanent roles
Willingness to travel up to 50-75%

Responsibilities

Performs and coordinates all aspects of the clinical monitoring and site management process
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation
Acts as a site processes specialist, ensuring the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subject rights, well-being, and data reliability
Ensures audit readiness
Develops collaborative relationships with investigational sites
Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters in a timely manner using approved business writing standards
Brings observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution
Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues, and timely data recording
Conducts monitoring tasks in accordance with the approved monitoring plan
Participates in the investigator payment process
Ensures shared responsibility with other project team members on issues/findings resolution
Investigates and follows up on findings as applicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS)
Performs QC check of reports generated from CTMS system where required
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client company

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementProtocol ComplianceRegulatory ComplianceClinical TrialsSite VisitsDocumentation ManagementCRA

Questions & Answers

Common questions about this position

What work arrangements are available for this Senior CRA position?

Positions can be fully homebased, fully office based in Munich or Karlsruhe offices, or hybrid, and are open across all locations in Germany near Frankfurt.

Is the role full-time or part-time, and what are the hours?

The role is permanent and open to full-time (40 weekly hours) or 80% FTE.

What experience level is required for this Senior CRA role?

This position is for experienced CRAs only, with a minimum of 2+ years experience as Senior CRA I/II.

What are the main responsibilities of a Senior CRA in this role?

The CRA performs and coordinates clinical monitoring and site management, conducts remote or on-site visits to assess compliance, ensures data accuracy, and develops collaborative relationships with sites, with travel up to 50-75%.

What skills are essential for success in this CRA position?

Candidates need skills in risk-based monitoring, root cause analysis, critical thinking, problem-solving, ensuring ICH-GCP compliance, and audit readiness.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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