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SMA I

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ICON plc

Jul 30

  • Job
    Full-time
    Entry Level
  • Frankfurt
  • Quick Apply

AI generated summary

  • You should have relevant experience in clinical research, strong organizational skills, attention to detail, and effective communication abilities. Knowledge of regulatory guidelines is a plus.
  • You will manage site activities, coordinate with stakeholders, ensure compliance with protocols, and support data collection for clinical trials, contributing to successful project execution.

Requirements

  • A Bachelor’s degree in the life sciences, expertise with regulatory guidelines and clinical terminology.
  • Demonstrable strong site management experience.
  • You will need to have fluent written and spoken German and English skills.
  • We would also welcome some previous experience as a CRA or an In- house CRA.

Responsibilities

  • Identifying, training/initiating and closing out of study sites.
  • Conducting remote site monitoring visits and/or targeted on-site visits as needed.
  • Conducting remote site management activities.
  • Managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.
  • Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed.
  • Maintains Sponsor and patient confidentiality.
  • Actively participates in regular meetings with Project Managers.
  • Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines.
  • Developing knowledge of and compliance with local regulatory requirements.

FAQs

What type of organization is ICON?

ICON is a Clinical Research Organisation (CRO) that focuses on advancing and improving patients' lives through drug development and clinical studies.

What is the main responsibility of a Site Management Associate (SMA) I at ICON?

The main responsibility of a Site Management Associate I is to manage, implement, and monitor clinical studies within a team setting, following ICON Standard Operating Procedures (SOPs), Site Specific Procedures (SSPs), and applicable regulations.

What are some specific duties included in the SMA I position?

Responsibilities include identifying, training, initiating, and closing out study sites; conducting remote monitoring visits; managing study protocols and timelines; assisting with regulatory document preparation; maintaining sponsor and patient confidentiality; participating in project team meetings; and developing site and patient enrollment strategies.

What qualifications are required for the SMA I position?

Candidates must have a Bachelor’s degree in life sciences, strong site management experience, fluent written and spoken proficiency in German and English, and prior experience as a Clinical Research Associate (CRA) or In-house CRA is welcomed.

What qualities does ICON seek in its employees?

ICON seeks individuals who embody their core values of Accountability & Delivery, Collaboration, Partnership, and Integrity, and who are driven to deliver excellence in their roles.

What kind of benefits does ICON offer its employees?

ICON offers competitive salary packages, annual bonuses, health-related benefits, competitive retirement plans, and an inclusive work environment that fosters personal fulfillment and career development.

Is ICON committed to diversity and inclusion in the workplace?

Yes, ICON is an equal opportunity and inclusive employer, ensuring a workplace free of discrimination and harassment, and all qualified applicants receive equal consideration for employment.

How can applicants request accommodations during the application process?

Applicants who require reasonable accommodations due to a medical condition or disability can inform ICON through the designated form in the application process.

What is the expected work environment for an SMA I at ICON?

The work environment is described as dynamic and supportive, allowing employees to collaborate with some of the brightest individuals in the clinical research sector while contributing to the industry.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.