Remote Senior Clinical Project Leader

EDETEK Inc.; United States; A distancia; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance and Benefits for US

Vacation & Sick Time

Corporate holidays

401K Plan

Perks & Discounts

Health Advocate & EAP

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. This remote role focuses on timelines, sponsor communication, risk management, vendor oversight, and quality delivery.

The ideal candidate has CRO experience and hands-on DMC coordination, capable of managing multiple stakeholders in a matrix environment, ensuring studies are delivered on time, within scope,

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.
• Strong CRO experience with sponsor-facing responsibilities.
• Experience coordinating or supporting DMC/IDMC activities.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Proven ability to manage multiple projects and stakeholders in a fast-paced environment.
• Experience with study risk management, vendor oversight, and issue escalation.
• Strong organizational, analytical, and problem‑solving skills.
• Excellent verbal and written communication skills.
• Proficiency with CTMS, EDC, eTMF and related project tracking tools.
• Ability to work effectively with global teams across time zones.
• Occasional travel may be required.

Responsabilidades

• Lead and manage clinical study activities from startup through closeout per protocol and regulations.
• Serve as the primary operational point of contact for assigned sponsors.
• Develop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers.
• Coordinate cross‑functional teams including clinical ops, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology.
• Facilitate internal and sponsor meetings with timely follow‑up on actions.
• Monitor study progress and identify operational risks, quality concerns, and timelines.
• Oversee study vendors and external partners to ensure deliverables meet timelines and quality.
• Support budget tracking, change orders, scope management, and resource planning.
• Ensure inspection readiness and support audits.
• Promote effective communication across global teams and functions.

Conocimientos

Clinical project management

Sponsor relationship management

DMC coordination

CRO operations

Vendor oversight

Risk identification & mitigation

Cross-functional collaboration

Timeline & budget management

Quality & compliance

Decision-making & accountability

Educación

Bachelor’s degree in life sciences, nursing, pharmacy, public health, or related field

Advanced degree preferred

Herramientas

CTMS

EDC

eTMF

Project tracking tools

Microsoft 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. This remote role focuses on timelines, sponsor communication, risk management, vendor oversight, and quality delivery.

The ideal candidate has CRO experience and hands-on DMC coordination, capable of managing multiple stakeholders in a matrix environment, ensuring studies are delivered on time, within scope,