Medical Director (Contract)

Sitero; United States; Teletrabalho; USD 207 000 - 317 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Variable pay

Paid time off

Healthcare benefits

Retirement benefits

Resumo da oferta

Sitero is seeking a Medical Director to provide strategic input on clinical projects and manage medical monitoring across trials. The role involves supporting investigators, coordinating data reviews, and contributing to regulatory communications, including FDA interactions.

Ideal candidates hold an MD or PhD in Endocrinology with 2+ years in clinical trials and will bring expertise in protocol development, medical writing, and trial oversight in a remote United States setting.

Qualificações

• Licensed MD or PhD in Endocrinology or related field.
• Minimum 2 years of clinical trials experience in medical monitoring.
• Endocrinology background; Pediatrics and metabolic trial experience preferred.

Responsabilidades

• Provide strategic input into current and potential clinical projects.
• Support site investigators and manage medical monitoring of trials.
• Prepare protocol deviations listings and adverse event reports.

Conhecimentos

Strong communication

Medical Writing

Independent worker

Excel

CTMS

Formação académica

MD or PhD in Endocrinology or related background

Ferramentas

CTMS

Descrição da oferta de emprego

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: United States Remote

Function: Clinical Services

Education: MD or PhD in Endocrinology or related background

Therapeutic Area: Endocrinology

DESCRIPTION

The Medical Director will provide strategic input into current and potential clinical projects, support site investigators and manage the medical monitoring in managing all medical aspects of clinical trials. The Medical Director is responsible for strategic input on potential projects that support proposal writing and bid-defense meetings including a deep understanding of therapeutic area’s current clinical research landscape. Support of data review and medical writing for protocols and study specific reports (regulatory annual reports, clinical study report (CSR)). Has experience in FDA interactions examples, all IND support (Pre- submission, Type A, B and C, and IDE support, Pre-Sub, Informal and Submission meetings). The Medical Director will also be responsible for review and addressing site and CRA queries for inclusion/exclusion criteria. 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

• Proven track record of Strategy development for FDA submission
• Protocol development
• Medical writing support for Protocol, and study reports
• Experience with FDA interactions
• Prepare and review protocol deviation listing
• Code protocol deviations per protocol deviation guidance
• Prepare drafts of appropriate study plans
• Prepare adverse event listings
• Assist the medical monitoring in management of clinical trials

EDUCATION AND EXPERIENCE REQUIRED

• Licensed MD or PhD.
• 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience
• Endocrinology
• Pediatrics (preferred)
• Metabolic trial experience (preferred)

PREFERRED SKILLS

• Strong communication
• Medical Writing
• Independent worker
• Excel
• CTMS

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.

• competitive salary
• Variable pay
• paid time off
• healthcare and retirement benefits

EMPLOYMENT TYPE

Contract; Part time, Hourly

COMMITMENTS

• Hourly as project requires
• 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.

Originally posted on Himalayas