Remote Senior Clinical Project Director - DMC & CRO Leader

EDETEK Inc.; Argentina; Presencial; ARS 164.000.417 - 253.455.191; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Vision and Dental Insurance

Paid vacation and sick days

Corporate holidays

Descripción de la vacante

EDETEK is seeking an experienced Senior Clinical Project Manager to lead planning, execution, and oversight of clinical trials for pharmaceutical, biotechnology, and medical device clients. The role emphasizes timeline management, sponsor communication, risk management, and vendor oversight in a matrix environment.

The ideal candidate will have CRO experience and hands-on DMC coordination, ensuring studies are delivered on time, within scope, and in compliance with applicable regulations.

Formación

• Bachelor's degree in life sciences, nursing, pharmacy, public health, or related field.
• Minimum of 7 years of clinical project management experience in pharma/biotech/medical device or CRO.
• Experience coordinating or supporting DMC/IDMC activities in clinical trials.
• Strong understanding of ICH-GCP and regulatory requirements.
• Excellent verbal and written communication skills.

Responsabilidades

• Lead clinical study activities from startup through closeout.
• Serve as the primary operational point of contact for sponsors and maintain relationships.
• Develop and manage study timelines, plans, reports, and risk registers.
• Coordinate cross-functional teams across clinical operations, data management, statistics, and regulation.
• Facilitate meetings and ensure timely follow-up on action items.
• Oversee vendors and budget tracking; ensure quality and timelines.
• Support audits and inspection readiness.

Conocimientos

Clinical leadership

Sponsor management

DMC coordination

CRO operations

Vendor oversight

Risk management

Cross-functional

Timeline management

Quality focus

Educación

Bachelor's in life sciences

Advanced degree preferred

Herramientas

CTMS

EDC

eTMF

MS Office

Descripción del empleo

EDETEK is seeking an experienced Senior Clinical Project Manager to lead planning, execution, and oversight of clinical trials for pharmaceutical, biotechnology, and medical device clients. The role emphasizes timeline management, sponsor communication, risk management, and vendor oversight in a matrix environment.

The ideal candidate will have CRO experience and hands-on DMC coordination, ensuring studies are delivered on time, within scope, and in compliance with applicable regulations.