Project Manager, GoClinical

PPG US ProPharma Group, LLC; Town of Deerfield (WI); Hybride; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

ProPharma Group seeks a seasoned Clinical Research Operations professional to oversee study plans, escalate issues, and manage vendor relationships across diverse therapeutic areas. You will develop training, coordinate site setups, and ensure adherence to ICH/GCP and SOPs.

The role emphasizes leadership of multidisciplinary teams, mentoring junior staff, and maintaining regulatory compliance throughout the study lifecycle.

Qualifications

• Current knowledge of ICH/GCP and applicable regulations.
• Proven track record of independent execution of successful studies from startup to closeout.
• Competent in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing).
• Well organized and able to multi-task.
• Positive and energetic attitude towards leadership of study teams.
• Professional, well spoken, and articulate.
• Experience mentoring, oversight, issue escalation and resolution.

Responsabilités

• Ensures timely operationalization of each project plan per SOPs and regulatory guidelines.
• Serves as main point of contact for issue escalation (Site, Sponsor, Vendors, GCPC, GCCM).
• Creates study-specific documents and training; submits to Sponsor for approval.
• Oversees site setup including DCV introduction and training.
• Develops protocol-specific training for GCCs and GCPCs.
• Manages study team communications and risk mitigation.
• Ensures compliance with Quality Management System and SOPs.

Connaissances

ICH/GCP knowledge

Independent study execution

SOPs & Regulations

Multi-tasking

Leadership

Communication

Team management

Formation

Bachelor’s degree

Description du poste

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

• 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.

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.

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.