Senior Clinical Trial Manager

Job not on LinkedIn

🔥 4 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $140k - $196k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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.

Apply Now

Find Similar Remote Jobs

Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Lead startup, execution, and closeout efforts for clinical studies, particularly late-stage COPD trials • Independently manage clinical trial operations, including CROs, central labs, biomarker and specialty laboratories, and clinical trial sites • Lead cross-functional internal study team meetings and deliverables • Identify, qualify, and select clinical trial sites and investigators with CROs; manage key relationships • Supervise day-to-day trial execution, including site startup, patient enrollment, monitoring, compliance, and data-flow metrics • Facilitate investigator, kick-off, monitoring-training, CRO, and vendor meetings • Develop and review informed consent forms, study guidelines, operations manuals, and training materials • Participate in developing protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials • Manage clinical study budgets and execution timelines; ensure adherence to program goals • Lead monitoring oversight visits and collaborate with CROs, investigators, and site staff on outcomes and findings • Review study reports and metrics for timely collection of clinical data, samples, and lab results • Collaborate on SOP development and standardized clinical business tools • Develop action plans addressing protocol compliance, safety, data, and administrative issues • Maintain and oversee the Trial Master File • Collaborate with QA and cross-functional teams on inspection readiness, TMF completeness, audit preparedness, and compliance with GCP, SOPs, and regulatory requirements • Prepare trial-data presentations for management reviews, scientific meetings, and advisory boards • Train and mentor junior staff • Report to the Director, Clinical Operations and collaborate with Data Management, Clinical Supply, Regulatory Affairs, and Preclinical Discovery & Development • Advance clinical-stage protein medicines using AI-driven generative biology

🎯 Requirements

• Bachelor’s degree required; advanced scientific degree preferred • 8+ years of experience in clinical operations • At least 4+ years in late stage trial operations with a sponsor company • Experience in various therapeutic areas; respiratory indications are a strong plus • Experience in CRO, vendor and laboratory oversight required • Motivated self-starter capable of flourishing in a fast-paced environment • Creative problem solver with excellent communication and public speaking skills • Strong interpersonal and organizational skills, attention to detail, and ability to interact with individuals at all team levels • Ability to travel for up to 30% of the time, domestically and internationally • Detailed knowledge of GCP • Knowledge of FDA, EMA, and MHRA regulatory requirements is a plus

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume