Senior Clinical Scientist

Jobtailor; Deutschland; Remote; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior clinical studies professional in Germany to lead and oversee external clinical investigations for medical devices. You will develop study protocols, manage sites, and ensure compliance with regulatory standards to support product development and market introduction.

Responsibilities include designing PMA/outcome studies, coordinating with cross-functional teams, and ensuring timely completion of studies.

Qualifikationen

• Bachelor's Degree or equivalent in a related field.
• Minimum 8 years in conducting clinical studies or related laboratory work.
• Experience with medical device studies and IDE trials desirable.
• Knowledge of medical device regulations desirable.
• Experience in medical device clinical trials preferred (TAVR).
• IDE trial experience preferred.
• Physician management experience.
• Safety management desirable.
• Experience collaborating with external clinical research committees.

Aufgaben

• Develops and/or reviews departmental operating procedures.
• Develops study protocols for executing experiments, evaluation, and documentation of results.
• Follows standard and complex procedures in executing studies, evaluation, and documentation of results.
• Participates in the development of clinical strategy for product development.
• Designs, executes, and monitors Abbott-sponsored external clinical studies, including PMA and outcome studies.
• Identifies and qualifies external clinical sites.
• Develops and maintains operating procedures.
• Participates in clinical strategy development to support product development and market introduction.
• Participates in cross-functional product development activities, including risk management.
• Completes clinical studies successfully and on time to support product development goals and product introduction timelines.

Kenntnisse

Clinical Study Management

Medical Device Clinical Trials

IDE Experience

Cross-Functional Collaboration

Regulatory Compliance Knowledge

Ausbildung

Bachelor's Degree in Related Field

Tools

PMA Study Design

External Clinical Site Qualification

Risk Management Tools

Jobbeschreibung

• Develops and/or reviews departmental operating procedures.
• Develops study protocols for executing experiments, evaluation, and documentation of results.
• Follows standard and complex procedures in executing studies, evaluation, and documentation of results.
• Participates in the development of clinical strategy for product development.
• Designs, executes, and monitors Abbott-sponsored external clinical studies, including PMA and outcome studies.
• Identifies and qualifies external clinical sites.
• Develops and maintains operating procedures.
• Participates in clinical strategy development to support product development and market introduction.
• Participates in cross-functional product development activities, including risk management.
• Completes clinical studies successfully and on time to support product development goals and product introduction timelines.

Requirements

• Bachelors Degree (± 16 years) In a related field and/or an equivalent combination of education and work experience.
• Minimum 8 years in conducting clinical studies or related laboratory skills.
• Experience in medical device related studies is desirable.
• Knowledge of regulations governing medical devices is desirable.
• Experience conducting medical device clinical trials preferred (TAVR in particular).
• Investigational Device Exemption (IDE) trial experience.
• Physician management.
• Safety management desirable.
• Experience working with external clinical research committees (i.e. screening committees, DSMB, CEC).

Core Competencies

Demonstrates expertise in developing and executing clinical study protocols, managing external clinical sites, and ensuring compliance with medical device regulations. Proven ability to collaborate in cross-functional product development and successfully complete clinical studies on time to meet product introduction goals.

Highest-signal resume keywords

• Clinical Study Management
• Medical Device Clinical Trials
• Investigational Device Exemption (IDE) Experience
• Cross-Functional Collaboration
• Regulatory Compliance Knowledge

Hard Skills

• Clinical Study Protocol Development
• Clinical Evaluation
• Documentation of Results
• Risk Management
• External Clinical Site Qualification
• PMA Study Design
• Outcome Study Execution
• Laboratory Skills
• Safety Management
• Physician Management

Certifications & Qualifications

• Bachelor's Degree in Related Field

Industry Keywords

• Medical Device Regulations
• Clinical Strategy Development
• Clinical Research Committees
• TAVR Studies
• External Clinical Studies