Strategic Clinical Trials Lead

Precision Medicine Group (New York, United States); Oregon; Ibrido; USD 111.000 - 201.000; Tempo pieno

Vantaggi offerti da questo lavoro

Discretionary annual bonus

Health insurance

Retirement savings plan

Descrizione del lavoro

Precision Medicine Group seeks an experienced clinical trial leader to plan, conduct, and oversee the operational aspects of studies in compliance with protocol, SOPs, ICH-GCP and applicable regulations. You will act as the primary client contact and collaborate with PM on budgets and study documents.

You will identify training needs, generate site lists, drive feasibility, manage regulatory submissions, and lead cross-functional teams to deliver milestones with high data quality and patient

Competenze

• Bachelor’s degree or equivalent in science/health-related field.
• Advanced degree preferred.
• Minimum 7 years of clinical research experience with monitoring.
• Experience with radiopharmaceuticals and/or CAR-T studies is preferred.
• Experience with Microsoft Office products.

Mansioni

• Serve as the clinical trial lead for planning, conduct and oversight of studies.
• Collaborate with PM on monthly invoicing and budget variance management.
• Develop study documents (e.g., clinical plans, ICF templates, CRF guidelines).
• Identify training needs for CRAs and third-party vendors.
• Drive site feasibility and country recruitment/retention strategies.
• Manage regulatory submissions to authorities and IRBs/ethics committees.
• Develop monitoring strategies to meet timelines and quality deliverables.
• Lead internal clinical team meetings and coordinate with QA for CAPA.

Conoscenze

Clinical monitoring

Budget management

Communication

Team leadership

Travel ability

Regulatory guidance

Formazione

Bachelor’s degree in science/health

Advanced degree preferred

Strumenti

Microsoft Office

CTMS

eTMF/Documentation tools

Descrizione del lavoro

Precision Medicine Group seeks an experienced clinical trial leader to plan, conduct, and oversee the operational aspects of studies in compliance with protocol, SOPs, ICH-GCP and applicable regulations. You will act as the primary client contact and collaborate with PM on budgets and study documents.

You will identify training needs, generate site lists, drive feasibility, manage regulatory submissions, and lead cross-functional teams to deliver milestones with high data quality and patient