Senior Consultant – Clinical Operations, Development

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ProductLife Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting • Healthcare • Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

• Leads or delivers defined clinical operations projects, studies, or complex workstreams • Manages assigned clinical studies, projects, or major workstreams against approved plans, timelines, budgets, quality expectations, and client requirements • Provides input into study and project strategy based on operational experience • Contributes advanced operational expertise to protocol development, study design, feasibility assessment, country and site planning, study start-up, enrollment, conduct, and closeout activities • Leads or contributes to clinical documentation including protocol synopses, protocols, informed consent forms, operational plans, risk assessments, vendor oversight plans, and clinical study reports • Supports or leads vendor and CRO selection, onboarding, oversight, performance monitoring, issue resolution, and risk mitigation • Develops and manages project plans, timelines, budgets, methodologies, dependencies, and status reporting • Identifies, assesses, documents, and manages study or project risks and develops mitigation plans • Supports preparation and review of clinical sections of regulatory submissions • Leads defined cross-functional workstreams across Clinical Operations, Regulatory, Quality, Data Management, Medical, Safety, Biometrics, vendors, and other contributors • Serves as a key contact for assigned projects or workstreams and communicates status, risks, recommendations, and decisions • Identifies and implements improvements to study execution, tools, templates, processes, quality, and ways of working • May lead project teams or defined groups of contributors and provide coaching, technical guidance, feedback, and day-to-day direction • Exercises independent judgment in non-routine situations and escalates broader business, client, financial, or cross-functional decisions • Contributes Clinical Operations expertise to project scoping, proposals, statements of work, client discussions, and follow-on opportunities • Participates in practice development, knowledge sharing, process-improvement initiatives, tool or service offering development, and relevant professional or industry activities

🎯 Requirements

• Bachelor’s Degree • 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, 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 factors

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