Remote Clinical Trial Lead | Study Oversight & Strategy

Precision Medicine Group; Raleigh (NC); À distance; USD 111 000 - 201 000; Plein temps

Avantages offerts par ce poste

Discretionary annual bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Résumé du poste

Precision Medicine Group is seeking a Clinical Trial Manager/Senior Clinical Trial Manager for remote-based operations in the United States. The role leads planning, conduct and oversight of clinical studies in alignment with protocol, SOPs and ICH-GCP.

You will serve as the primary client contact, develop study documents, manage budgets, lead team meetings, and ensure regulatory submissions and IP management are handled efficiently. Extensive travel may be required.

Qualifications

• 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.

Responsabilités

• Serve as the clinical trial lead responsible for planning, conduct and oversight of the operational portion of clinical studies in accordance with protocol, SOPs, ICH-GCP and regulatory requirements.
• Primary clinical point of contact with the client and collaborate with PM on monthly invoicing and variance management of clinical budget.
• Develop study related clinical documents and training materials; identify training needs for CRAs and third-party vendors.
• Lead internal clinical team meetings and set expectations for the clinical team of CRAs and CTAs; review and approve IP release packages.
• Oversee submissions and approvals to Competent Authorities and IRB/ Ethics Committees; develop monitoring strategies to ensure timelines and quality.

Connaissances

Communication

Interpersonal skills

Time management

Negotiation

Critical thinking

Decision making

Analytical skills

Formation

Bachelor’s degree

Advanced degree

Outils

Microsoft Office

Description du poste

Precision Medicine Group is seeking a Clinical Trial Manager/Senior Clinical Trial Manager for remote-based operations in the United States. The role leads planning, conduct and oversight of clinical studies in alignment with protocol, SOPs and ICH-GCP.

You will serve as the primary client contact, develop study documents, manage budgets, lead team meetings, and ensure regulatory submissions and IP management are handled efficiently. Extensive travel may be required.