Clinical Trials Project Manager, DCT Lead (Remote)

ProPharma; Deerfield (MA); Híbrido; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

ProPharma is seeking a results-driven professional to oversee decentralized clinical trials (DCT) and manage study teams across regulatory and operational activities. You will ensure adherence to ICH/GCP guidelines, SOPs, and project plans while coordinating between sites, sponsors, and vendors.

Ideal candidates bring 2+ years of clinical research experience and a track record of delivering studies on time and within budget.

Formación

• Current knowledge of ICH/GCP and applicable regulations and guidelines.
• Proven ability to independently execute studies from startup to closeout.
• Experience applying SOPs, global regulations, OEC, and outsourcing.

Responsabilidades

• DCT study oversight and management.
• Ensure timely operationalization and adherence to SOPs and regulatory guidelines.
• Serve as main point of contact for issue escalation (Site, Sponsor, Vendors, GCPCs, GCCMs).
• Create study-specific documents and training and submit to Sponsor for approval.
• Oversee site setup including DCV introduction and training.
• Develop protocol-specific training for GCCs and GCCMs.
• Set up and manage vendors for each study.
• Organize Sponsor/CRO, Central Lab and Vendor teleconferences.
• Track study objectives and KPIs for Decentralized Visits.
• Manage monthly trackers, invoices, and GCC payments.
• Provide guidance to GCPCs and GCCs.

Conocimientos

ICH/GCP knowledge

Independent execution

SOP adherence

Multi-tasking

Leadership

Communication

Educación

Bachelor's Degree or equivalent

Descripción del empleo

ProPharma is seeking a results-driven professional to oversee decentralized clinical trials (DCT) and manage study teams across regulatory and operational activities. You will ensure adherence to ICH/GCP guidelines, SOPs, and project plans while coordinating between sites, sponsors, and vendors.

Ideal candidates bring 2+ years of clinical research experience and a track record of delivering studies on time and within budget.