Medical Director

2 tygodni temu

Warszawa, Mazovia, Polska Sitero LLC Pełny etat

Medical Director

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Medical Director

Location: Poland

Function: Clinical Services

DESCRIPTION:

The Medical Director will assist the medical monitoring in managing all medical aspects of clinical trials. The Medical Director administers the Sitero Mentor Event Reporting system to facilitate the evaluation and reporting of adverse events, serious adverse events and adverse event of special interest. The Medical Director will be responsible for preparing listings of protocol deviations and adverse events for regular meetings, performing initial review for coding and reconciling coding based on the inputs of the clinical and medical teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Prepare and review protocol deviation listing
  • Code protocol deviations per protocol deviation guidance
  • Prepare draft of medical monitoring plan for the medical monitoring
  • Query CRAs for clarification on protocol deviations
  • Prepare adverse event listings
  • Code adverse events and serious adverse events
  • Assist the medical monitoring in management of clinical trials
  • Administer Sitero Mentor Event Reporting system

EDUCATION AND EXPERIENCE REQUIRED:

  • 5 years of experienced working in clinical trials as a medical monitoring associate or equivalent relevant experience
  • A Medical professional with MD and/or PhD degrees.
  • Conducting and development of gastroenterology and immunology clinical trials.
  • Experience in working in interdisciplinary research team for 3-5 years.
  • Ability to effectively communicate with physicians in English.
  • GI residency with endoscopy experience is a plus.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

  • If Medical Director is in Poland, this is a Full Time, Permanent position
  • If Medical Director is outside of Poland, this is a Contract position

COMMITMENTS:

  • Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
  • Willing to work in shifts as and when needed.

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.


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