Clinical Trial Lead: Strategy, Oversight & Execution

Precision For Medicine; Peapack-Gladstone (NJ); Presencial; USD 111 000 - 201 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Resumo da oferta

Precision Medicine Group in the United States seeks a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP, and regulatory requirements.

You will coordinate with PMs, CRAs, and vendors to ensure timelines, study start-up, enrollment, and data integrity while maintaining strong client relationships across sites and teams.

Qualificações

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred.
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
• Advanced degree preferred

Responsabilidades

• Serve as the primary clinical point of contact with the client.
• Collaborate with PM on monthly invoicing and variance management of clinical budget.
• Develop study related clinical documents (e.g. clinical plans, ICF templates, study manuals, CRF guidelines, trackers).
• Identify and develop training needs for CRAs and third‑party vendors; present at Investigator Meetings and Study Kick‑offs.
• Generate potential site list from key stakeholders and drive feasibility.
• Identify risks to enrollment based on feasibility and site commitments.
• Develop country recruitment/retention strategy; ensure effective communication with investigators and study team.
• Lead internal clinical team meetings and set expectations for CRAs and CTAs.
• Assist in regulatory submissions to Competent Authorities and IRB/Ethics Committees; coordinate with regulatory teams.
• Develop and monitor clinical monitoring strategies to meet timelines and quality deliverables.
• Oversee CAPA development and ensure timely closure; support GCP audits.
• Assist sites and staff with data quality, IP management, and data reviews.

Conhecimentos

Communication skills

Interpersonal skills

Organizational skills

Travel flexibility

Formação académica

Bachelor’s degree or equivalent in science/health-related field

Advanced degree preferred

Minimum 7 years of clinical research experience

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Precision Medicine Group in the United States seeks a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP, and regulatory requirements.

You will coordinate with PMs, CRAs, and vendors to ensure timelines, study start-up, enrollment, and data integrity while maintaining strong client relationships across sites and teams.