Clinical Project Manager

Job Description

This is an INTERIM project, 6 month duration aprox. sponsor exclusive and office-based, with some home-based flexibility.

Responsibilities:

• Proactively manage project level operational aspects of Clinical Trial including management of trial timeline, budget, resources and vendors.
• Provide efficient updates on trial progress to the Clinical Operations Manager, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
• Ensure effective project plans are in place and operational for each trial and work proactively with the COM to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Ensure potential study risks are escalated to the attention of the COM when appropriate.
• Lead study meetings and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
• Review site visit reports according to Sponsor Oversight plan; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Study Budget control with invoicing revision and approval according to executed contracts
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Review responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.

Requirements:

• Bachelor's degree in Life Sciences, Pharmacist, science degree
• Minimum years of clinical trials experience at a Sponsor or CRO. Must have a thorough knowledge of clinical research concepts, practices, guidelines and regulations covering early phase trials (Phase I-II) and Phase III trials.
• Experience in observational studies will be very valuable
• Read, write and speak fluent English
• Excellent verbal and written communication skills

Gerelateerde vacatures aan Clinical Project Manager

Clinical Project Manager - Sponsor Dedicated

Manager, Clinical Data Management

Site Innovation Project Manager

Regulatory Manager, Clinical Trials Regulatory Manag...