Early-Phase Clinical Program Lead

Syneos Health, Inc.; United States; In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Syneos Health is seeking an Early Phase Clinical Project Manager to lead interdisciplinary clinical studies from initiation to closeout in compliance with GCP and regulatory requirements. You will manage timelines, budgets and sponsor relationships to ensure on-time study delivery.

The role requires strong organizational and communication skills, the ability to work independently, and travel up to 25% to sites and meetings across the United States.

Competenze

• Bachelor's degree or equivalent in life sciences, medicine, pharmacy, nursing or related field.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines and regulatory requirements.
• Strong organizational skills and ability to manage time independently.
• Excellent communication, presentation and interpersonal skills, written and spoken.
• Ability to travel approximately 25%.

Mansioni

• Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements. Accountable for all project deliverables for each project assigned.
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• May participate in bid defense meetings where presented as potential project manager.
• May be required to line manage other project management team members and clinical monitoring staff.

Conoscenze

Strong organizational skills

Time management

Independent work

Excellent communication

Formazione

Bachelor's Degree in life sciences, Medicine, Pharmacy, Nursing or equivalent

Descrizione del lavoro

Syneos Health is seeking an Early Phase Clinical Project Manager to lead interdisciplinary clinical studies from initiation to closeout in compliance with GCP and regulatory requirements. You will manage timelines, budgets and sponsor relationships to ensure on-time study delivery.

The role requires strong organizational and communication skills, the ability to work independently, and travel up to 25% to sites and meetings across the United States.