Senior Consultant - Clinical Operations & Development

PLG; United States; Sur place; USD 140 000 - 180 000; Plein temps

Résumé du poste

ProductLife Group seeks a Senior Consultant in Clinical Operations & Development to lead delivery of complex clinical studies and programs. You will manage scope, timelines, budgets, and quality while coordinating with regulatory, quality, data management, and vendors.

The role demands extensive CRO/vendor oversight, strategic input on study design and feasibility, and proactive risk management to ensure timely program success in a fast-paced biopharma environment.

Qualifications

• Bachelor’s Degree and a minimum of twelve years of experience in Clinical Operations in a biotechnology or pharmaceutical setting.
• Demonstrated history of Clinical Program oversight and Strategic Development Activities.
• Deep familiarity with current regulatory guidance and GxP practices.

Responsabilités

• Leads or delivers defined clinical operations projects, studies, or complex workstreams.
• Manages assigned clinical studies against plans, timelines, budgets, quality expectations, and client requirements.
• Provides input into study and project strategy based on operational experience.
• Leads cross-functional collaboration among Clinical Operations, Regulatory, Quality, and other teams.

Connaissances

Clinical Operations

Vendor management

Regulatory compliance

Cross-functional leadership

Project management

Study delivery

Formation

Bachelor's Degree

Description du poste

## Senior Consultant - Clinical Operations & DevelopmentApply: Remote: No Office - USA based: Full time: Posted Today: JR000077Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‐thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‐driven work.**Job Description :****Specific activities and responsibilities:** Overall Role Scope:Leads or delivers defined clinical operations projects, studies, or complex workstreams. Applies advanced Clinical Operations expertise to address non-standard issues and support successful study execution. Clinical study and program delivery:Manages assigned clinical studies, projects, or major workstreams against approved plans, timelines, budgets, quality expectations, and client requirements. Identifies delivery risks and recommends corrective actions. Operational strategy:Provides input into study and project strategy based on operational experience. Evaluates study requirements, interdependencies, risks, and execution options and recommends practical solutions to improve cost, timing, quality, or feasibility. Protocol and study planning:Contributes advanced operational expertise to protocol development, study design, feasibility assessment, country and site planning, study start-up, enrollment, conduct, and closeout activities. Challenges assumptions and identifies execution risks. Clinical documentation:Leads or contributes to the development and review of protocol synopses, protocols, informed consent forms, operational plans, risk assessments, vendor oversight plans, and clinical study reports within the assigned project scope. Vendor and CRO management:Supports or leads vendor and CRO selection, onboarding, oversight, performance monitoring, issue resolution, and risk mitigation for assigned studies or services. Escalates issues with broader contractual, financial, or program impact. Project planning and control:Develops and manages project plans, timelines, budgets, methodologies, dependencies, and status reporting for assigned work. Exercises judgment when priorities or requirements change. Risk and issue management:Identifies, assesses, documents, and manages study or project risks. Develops mitigation plans and escalates risks that may affect other projects, functions, client commitments, or business objectives. Regulatory and quality support:Supports the preparation and review of clinical sections of regulatory submissions. Applies current regulatory requirements, GxP expectations, internal procedures, and industry practices to assigned work. Cross-functional leadership:Leads defined cross-functional workstreams and coordinates activities among Clinical Operations, Regulatory, Quality, Data Management, Medical, Safety, Biometrics, vendors, and other contributors. Client and stakeholder management:Serves as a key contact for assigned projects or workstreams. Communicates status, risks, recommendations, and decisions clearly and adapts messaging to the needs of the audience. Continuous improvement:Identifies and implements improvements to study execution, tools, templates, processes, quality, and ways of working within assigned projects or the immediate team. People and project leadership:May lead a project team or defined group of contributors. Provides coaching, technical guidance, feedback, and day-to-day direction to less experienced colleagues. May support onboarding and capability development. Decision-making authority:Exercises independent judgment in non-routine situations within the assigned role or project. Determines approaches to complex work and escalates decisions with broader business, client, financial, or cross-functional consequences. Business development and proposals:Contributes Clinical Operations expertise to project scoping, proposals, statements of work, client discussions, and identification of follow-on opportunities. Internal contribution:Participates in practice development, knowledge sharing, process-improvement initiatives, development of tools or service offerings, and relevant professional or industry activities. **Required education:**Bachelor’s Degree and a minimum of twelve years of experience in Clinical Operations in a biotechnology or pharmaceutical setting. **Required experience:*** Demonstrated history of Clinical Program oversight and Strategic Development Activities* Deep familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends* Ability to balance multiple priorities and sophisticated issues using logical, creative, analytical, and efficient processes with a high level of attention to detail and quality of work* Exercise good judgment in selection methods, techniques and evaluation criteria for issues that may require in-depth evaluation of variable factorsReady to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.