Senior Project Manager - Rare Disease

ProPharma Group; Chicago (IL); Hybrid; USD 95,000 - 145,000; Full time

Job summary

ProPharma Group is seeking a seasoned Clinical Project Manager to lead studies across the full lifecycle, coordinating internal teams and external partners. You will ensure regulatory compliance, manage timelines and budgets, and drive delivery of study milestones with a focus on quality and patient safety.

The role emphasizes collaboration with cross-functional groups, TMF oversight, measurement of study metrics, and proactive risk management to support sponsor programs and regulatory

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.

• Plans and manages assigned studies from start to close out while
• managing project timelines and project budget.
• Proactively anticipates and understands concerns/issues/delays in theproject and develops risk assessment and contingency plans.
• Holds eachfunctional area responsible for associated risk mitigation andmanagement.
• Primary source of communication for the clinical project team as well as the cross functional project teams both internal and external
  stakeholders.
• Participates in project kick-off meetings, provides regular updates toclient, and ensures maintenance of communication between team
  members and client.
• Monitors project budget vs. cost. Responsible for timely execution ofchange orders to ensure that the project margins are being met.
• Tracks and forecasts budget, metrics, timelines progress for all projectdeliverables to enable better project decisions.
• Gathers metrics from cross-functional areas in relation to projectprogress.
• Provide study-specific training for the assigned clinical operations staffas appropriate.
• Evaluate and identify resourcing needs and continuously monitor the life cycle of the study.
• Develop, analyze, and report study metrics to Sponsor per Project Planand proactively identify and communicate any risks or concerns.
• Develop and maintain Study Project Plans including, but not limited to,site selection and monitoring plans, TMF management plan, paymentplans, etc. Also responsible for creating, training, and updating studyspecific tools and templates to be used throughout the course of thetrial.
• Provide strategic input into study documents such as study synopsis,
• protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans,Clinical Data Review Plan, Safety Plan, Clinical Database editspecifications, Annotated Monitoring Visit Report templates, ClinicalStudy Report development, etc. as assigned.
• Manages study drug product and non-drug site supplies (study
• materials/equipment/manuals), deliverable development, shipment,tracking accountability and resupply to sites as needed.
• Develops the agenda and manages the planning and execution of
• Investigator Meetings: meeting vendor contracting and management, coordinate development of meeting agenda, content development anddelivery of operational (non-Clinical Science) presentations and trainingmaterials, manage meeting execution and documentation; ensure inputfrom key stakeholders.
• Responsible for the development and presentation of slides and trainingmaterials for various audiences.
• Assists with vendor selection (ECG, Lab, IWRS, IRB, Raters) and
• contracting for assigned studies.
• Ensures clinical study team compliance with applicable FDA / ex-US
• regulations, ICH-GCPs, other local regulatory requirements and
• corporate SOPs.
• Develop subject recruitment/retention strategy and related initiatives
• for assigned studies.
• Collaborate and communicate with other functional areas to identify
• and evaluate fundamental issues on study related projects.
• Leads and/or participates in investigator, client, and cross-functional
• team meetings.
• Oversee maintenance and quality review of study TMF.
• Develop and maintain tools for management of study deliverables (i.e.,timelines, study plans, adherence to monitoring plan and TMF plan, etc.).
• Other duties as assigned

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 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.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***