Remote Senior Clinical Project Leader: Growth & Impact

United Biosource Corporation; EE. UU.; A distancia; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Discretionary PTO (Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Descripción de la vacante

United Biosource Corporation is seeking a REMS Senior Project Manager to lead project teams from initiation to close-out, coordinating sponsors, investigators, and vendors across REMS-related studies. You will drive milestones, budgets, and regulatory deliverables while building strong client relationships.

The role requires in-depth knowledge of GCP/ICH guidelines, effective supervision of PMs, and the ability to influence cross-functional teams.

Formación

• BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experience.
• Excellent supervisory skills.
• Excellent interpersonal skills and presentation abilities; decisive risk mitigation.
• Strong knowledge of regulatory requirements (GCP, ICH, etc.).
• 10% travel requirement and willingness to travel as needed.

Responsabilidades

• Serve as the primary sponsor contact for all study-related items from start-up through close-out, adhering to SOPs, budgets, timelines and contracts.
• Lead cross-functional project activities and special projects; supervise PMs and team members to ensure on-time delivery.
• Assist in the development of protocols, CRFs, regulatory documents and project master files; ensure audit readiness.
• Develop and manage communication, monitoring, and training plans; track progress against plans and ensure compliance.
• Lead investigator meetings, negotiate budgets, and support client proposals and RFP responses.
• Support project audits and regulatory inspections; provide timely reporting to sponsors; mentor junior staff.

Conocimientos

Project management

Supervisory skills

Interpersonal skills

Presentation skills

Regulatory knowledge

Travel willingness

Educación

Bachelor's degree

Descripción del empleo

United Biosource Corporation is seeking a REMS Senior Project Manager to lead project teams from initiation to close-out, coordinating sponsors, investigators, and vendors across REMS-related studies. You will drive milestones, budgets, and regulatory deliverables while building strong client relationships.

The role requires in-depth knowledge of GCP/ICH guidelines, effective supervision of PMs, and the ability to influence cross-functional teams.