Project Manager, GoClinical

ProPharma; United States; Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

ProPharma in the United States is seeking a seasoned clinical research professional to oversee decentralized clinical trial (DCT) study activities from startup to closeout. You will lead study teams, ensure adherence to ICH/GCP, and manage vendor relations to deliver on time, within budget, and with high quality.

This role emphasizes collaboration across Sponsor, CRO, and internal sites, with a hybrid work model and opportunities to mentor GCPCs, GCCMs, and GCPCs while upholding ProPharma's SOPs

Qualifications

• Current knowledge of ICH/GCP and applicable regulations.
• Proven ability to independently execute studies from startup to closeout.
• Strong SOPs, global regulations, and outsourcing know-how.

Responsibilities

• DCT study oversight and management.
• Prioritize tasks per study plan and SOPs to ensure on-time delivery.
• Main escalation point for site, sponsor, vendors, and GCPC/GCCM.
• Create study documents and training; submit for sponsor approval.
• Oversee site setup including DCV introduction and training.
• Develop protocol-specific training and amendments for GCCs and GCPCs.
• Manage vendors (central pharmacy/lab/equipment) for each study.
• Lead Sponsor/CRO, Central Lab and Vendor teleconferences.
• Track objectives and KPIs for Decentralized Visits.
• Handle monthly unit trackers, invoices, and GCC payments.
• Provide guidance to GCPCs and GCCs; ensure quality management.
• Escalate risks and mitigation plans to leadership; manage study closeout.

Skills

ICH/GCP regulations

Independent study execution

SOPs & Global Regulations

Multi-tasking & organization

Leadership & mentoring

Professional communication

Education

Bachelor's Degree or equivalent experience

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions

• 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.

Necessary Skills and Abilities

• 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.

Educational Requirements

• 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.

Experience Requirements

• 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.

Diversity & Inclusion

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.