Project Manager, GoClinical

Responsibilities

• DCT study oversight and management
• Ensures timely operationalization of each project plan, by setting priorities for each study team member in accordance with project plans, ProPharma Group Standard Operational Procedures (SOPs), ICH/GCP guidelines and all regulatory guidelines
• Main point of contact for all issue escalation (Site, Sponsor, Vendors, GoClinical Project Coordinators (GCPC) and GoClinical Clinician Managers (GCCM)
• Creates study-specific documents and training and submits to Sponsor for approval
• Oversees site setup including DCV introduction and training
• Develops and delivers protocol specific training and applicable amendment training to GoClinical Clinicians (GCCs), GCCMs, and GCPCs
• Sets up and maintains necessary vendors for each study (e.g., central pharmacy, central lab, equipment)
• Organizes and leads Sponsor/CRO, Central Lab and Vendor teleconferences
• Tracks objectives and key performance indicators related to all Decentralized Visits
• Manages monthly unit trackers, invoices, and GCC payments
• Provides guidance to GCPCs and GCCs assigned to projects
• Complies with Quality Management System and applicable SOPs
• Escalates risk and risk mitigation plans for all study related issues to Associate Director, DCT or designee
• Communication to all study teams and management of study closeout
• Other duties as assigned

Preferred

• Phase II or Phase III, global experience, and experience in multiple therapeutic areas or disease state/indications desirable

Benefits

• Remote working is supported; new hires based within a reasonably short commute of an office are encouraged to work on a hybrid basis and spend some time working from that office, as agreed with their manager.
• Glassdoor
• 3.5
• Regulatory, clinical, and compliance services for life sciences.
• Raleigh, North Carolina, USA
• http://www.propharmagroup.com/
• Late Stage
• Total Funding
• $8.63M
• Key Investors
• Jump Capital
• 2020-10-23
• Series Unknown· $8.63M
• 2020-09-22
• Acquired
• 2015-03-25
• Series Unknown
• Leadership Team
• Dawn Sherman
• CEO and Board Chair
• Marshall Florence
• Vice President Labeling and Strategy
• Recent News
• PR.com
• Rob Merrill Named CEO of TFives, Life Sciences AI Compliance
• 2026-09-18
• PR Newswire
• ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development
• 2026-07-10
• ProPharma Appoints Adrian Pencak as Chief Commercial Officer

Qualifications

• Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines
• Proven track record of independent execution of successful studies (delivered on time, within budget, and with high quality) from startup to closeout
• Competent in application of standard business procedures (SOPs, Global Regulations, OEC, and Outsourcing)
• Well organized and able to multi-task
• Positive and energetic attitude towards all aspects of the role including leadership of study team
• Professional, well spoken, and articulate
• Management of study team, mentoring, oversight, providing issue escalation, and resolution
• Bachelor's Degree or equivalent experience defined as a minimum of 5 years related, combined experience in education, knowledge, and skills that will enable the incumbent to perform the tasks of the role proficiently
• A minimum of 2 years of direct clinical research experience including experience in managing and completing clinical trials from pre-study activities through study completion and data summarization
• Phase II or Phase III, global experience, and experience in multiple therapeutic areas or disease state/indications desirable
• Bachelor’s Degree or equivalent experience defined as a minimum of 5 years related, combined experience in education, knowledge, and skills that will enable the incumbent to perform the tasks of the role proficiently.
• A minimum of 2 years of direct clinical research experience including experience in managing and completing clinical trials from pre-study activities through study completion and data summarization.

Required skills

• Clinical Data Summarization, Clinical Research, Clinical Research Regulations, Clinical Trial Management, Global Clinical Trials, ICH/GCP, Phase II/III Clinical Trials, Standard Operating Procedures (SOPs), Study Team Leadership

Experience

• 2+ years