Site Operations Director

2 tygodni temu

Gdynia, Pomerania, Polska Thermo Fisher Scientific Pełny etat

This is a challenging yet rewarding opportunity to lead our research site in Gdynia, Poland.

Company Overview

At Thermo Fisher Scientific, we strive to make a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research.

Job Summary

The Manager, Sites is responsible for providing overall leadership, strategy and accountability for the efficiency, quality, operational performance of the site.

This role involves managing staff, which includes interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.

Main Responsibilities
  • Manage multiple key studies to ensure delivery at site level and oversee resource allocation of studies to staff.
  • Review protocols, case report forms and investigator's brochures. Collaborate with management to clarify study questions prior to study start.
  • Train and orient new team members and other clinic staff in basic research processes, new therapeutic areas or unfamiliar study related procedures.
  • Provide leadership and supervision of clinical staff within the research sites, ensuring that all study related tasks are properly planned and executed with adequately trained and skilled team members.
  • Participate in clinic process improvements, QA/QC initiatives and issue resolutions.
  • Participate in day-to-day clinical study activities and procedures, ensuring efficient workflow and appropriate management of research subject's activities.
Requirements

We are looking for a candidate with a Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

A minimum of 1 year of leadership responsibility is required, along with previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-5 years).

Fundamental communication and interpersonal skills, with the ability to manage, motivate and mentor staff are essential.

Strong organization skills, with the ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations are also necessary.

A strong understanding of budgets, project planning and performance metrics is required.

English language proficiency, both written and verbal, is crucial, with a second language being an advantage.

Sound knowledge of taxonomies (folder structures, metadata, user access), Records Management principles, FDA Good Clinical Practices, ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents is required.

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