Senior Clinical Project Manager

The Steely Group Norwood , MA 02062

Posted 3 months ago

The Senior Clinical Project Manager is responsible for the successful execution of clinical trials from protocol conception through the clinical study report.   The Senior Clinical Project Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

JOB RESPONSIBILITIES:
1.     Manages clinical operations aspects of clinical studies, including: 
  Clinical Trial Overall: 	
Develop comprehensive study timelines and metrics  	
Develop and manage study budget within financial goals 	
Prepare and present project debriefings, as required; plan, execute, and lead or participate in study-specific meetings    Vendor Management: 	
Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations  	
Assist in the selection and evaluation of study personnel (contract and internal) 	
Provide study-specific training and leadership to clinical research staff, and other contract personnel; 	
Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs 	
Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics Site Selection and Management: 	
Participate in site and country selection. Develop relationships with investigators and site staff. 	
Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments 	
Manage clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations 	
Participate in site monitoring visits as appropriate  2.     Uses operational and therapeutic expertise to optimize trial design and execution:  	
Design clinical trial protocols with study team consistent with clinical development plan 	
Develop ongoing data review plan to ensure data trend detection and study objectives are met  	
Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc. 	
Prepare and/or review study-related documents: Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completion Guidelines 	
Provide input and support documentation for adverse event safety monitoring while collaborating FDA and regulatory authorities report submissions 	
Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution  3.     Ensures all clinical trial execution within compliance of international GCP guidelines/regulations and SOPs:  	
Participate in planning of QA activities and coordinate resolution of audit findings  	
Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issues 	
Coordinate and assist regulatory or ethics committee activities planning 	
Provide staff oversight maintaining clinical trial master files to ensure appropriate compliance  4.     Lead and consistently be present for the Cross-Functional Study Team as well as internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)

JOB REQUIREMENTS: 	
Bachelor’ s Degree (health, biologic science or related field) required; Master’ s Degree preferred 	
Minimum of 5 years' clinical study management experience in biopharmaceutical industry, including at least 2 years as a clinical study lead/project manager, required 	
Prior experience managing contracted resources/CRO required 	
Site monitoring and clinical data review highly preferred 	
Clinical quality compliance experience highly preferred 	
Advanced knowledge of GCP and current knowledge of CFR for IND clinical trials required 	
Knowledge of ICH and other country regulatory requirements is preferred 	
Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required


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Senior Clinical Project Manager

The Steely Group