Clinical Operations - Global Lead

Avant Health LLC; Bethesda, Northern (MD, KY); Hybrid; USD 120,000 - 190,000; Full time

Job summary

Avant Health LLC is seeking a Clinical Research professional to direct clinical studies, ensure proper resourcing and trained staff, and meet project objectives.

You will work with senior leadership to formulate strategic goals and ensure operational alignment with organizational priorities.Responsibilities include designing and executing Phase-2b and Phase-3 trials and large non-interventional studies; developing study documents and trial SOPs aligned with GCP/ICH.

Qualifications

• Requires degree in life sciences, nursing or medicine.
• Minimum 5 years of clinical trial leadership experience, ideally in a full-service CRO.
• Global Phase-2b/Phase-3 trial experience.
• Knowledge of GCP/ICH guidelines and FDA/EMA requirements for clinical trial management.
• Knowledge of regulatory reporting and compliance requirements.
• Hands-on experience in managing CTMS and EDC portals.
• Strong project management skills and effective communication.
• Familiar with scientific literature search and evaluation.
• Spanish/French/German language skills are optional.

Responsibilities

• Direct clinical studies and ensure appropriate resourcing and trained staff.
• Work with senior leadership to formulate strategic goals and align operations with priorities.
• Design and execute Phase-2b and Phase-3 trials and large non-interventional studies.
• Develop research study documents and trial SOPs per GCP/ICH and regulations.
• Develop and maintain procedures for regulatory reporting and compliance.
• Manage CTMS and EDC platforms.
• Create research reports, abstracts, posters and manuscripts.
• Engage and communicate effectively with internal and external stakeholders.

Skills

Project management

Technical writing

Communication

Literature review

Multilingual (ES/FR/DE)

Education

Life sciences degree

Tools

CTMS

EDC

Job description

As a Clinical Research professional, you will direct clinical studies to ensure projects are appropriately resourced and staff are trained, and project objectives are met. You will work with senior leadership in formulating effective strategic goals and objectives for designated team and clients and ensure operational alignment with organization priorities.

• Design and execute Phase-2b and Phase-3 clinical trials and large non-interventional studies (NIS)
• Develop research study documents and trial SOPs, aligned with GCP/ICH guidelines and other applicable regulations
• Develop and maintain procedures for regulatory reporting and compliance
• Manage CTMS and EDC platforms
• Create research reports and other documents in PPT and MS Word formats
• Conduct literature reviews on various scientific topics
• Create abstracts, posters, manuscripts
• Engage and communicate effectively with internal and external stakeholders
• Create abstracts, posters, manuscripts
• A degree in life sciences, nursing or medicine
• A minimum of 5 years of prior clinical trial leadership experience, ideally in a full-service CRO setting
• Global Phase-2b/Phase-3 trial experience
• Knowledge of GCP, ICH guidelines and regulatory (FDA/EMA) requirements for clinical trial management
• Knowledge of regulatory (FDA/EMA) reporting and compliance requirements
• Hands-on experience in managing CTMS and EDC portals
• Proficient in project management skills
• Strong technical writing skills, and communication skills
• Familiar with scientific literature search/evaluations
• Native-level proficiency in Spanish, French or German (optional)