Clinical Trial Lead

SerenaGroup Inc.; United States; Remote; USD 125,000 - 220,000; Full time

Job summary

A growing company is seeking a Clinical Trial Lead to manage and oversee clinical studies from initiation through final reports. This role requires excellent organizational skills and a knack for managing various external partners while ensuring compliance and maintaining project timelines.

Qualifications

• Effective communicator, both written and spoken.
• Intermediate reasoning and problem-solving ability.

Responsibilities

• Manage external partners from study start-up through final reports.
• Ensure studies follow all GCP/ICH guidelines and regulatory requirements.
• Own study timelines, budgets, and quality metrics.

Skills

Communication

Problem Solving

Adaptability

Education

Associate degree or equivalent relevant experience

Job description

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The SerenaGroup is growing fast, and we're looking for a Clinical Trial Lead who thrives in a dynamic environment. If you're a natural organizer, love collaborating with smart people, and have a knack for keeping clinical studies on track, you might be the person we're looking for.

What You'll Do

You'll be the operational lead for clinical studies—planning, launching, and running trials from start to finish. You'll juggle vendors, sites, sponsors, and all the details in between, ensuring everything runs smoothly, stays compliant, and gets done on time (and on budget).

Key Responsibilities

• Manage external partners (labs, device companies, service providers) from study start-up through final reports.
• Make sure studies follow all GCP/ICH guidelines and regulatory requirements.
• Own study timelines, budgets, and quality metrics.
• Lead protocol development, informed consent, CRFs, and other study documents.
• Build strong relationships with investigators and site staff to ensure smooth operations and compliance.
• Track and communicate study progress, issues, and mitigation plans to management.
• Handle regulatory submissions (including eTMF, IRB, and ClinicalTrials.gov).
• Run sponsor meetings, provide updates, and manage sponsor billing.
• Oversee site initiation, monitoring, and budgets; act as the key site-sponsor liaison.
• Maintain site metrics and EDC system access.

What Makes You a Great Fit

• You pick up new skills fast and love learning on the job.
• Details matter to you—you spot and fix problems before they snowball.
• You're adaptable and thrive when things change (because they will).
• You take initiative and find ways to improve processes rather than just waiting for instructions.
• You're motivated by meaningful work and share our values.
• You solve problems with logic and creativity.
• You're a team player who builds trust and drives a positive, collaborative vibe.
• You have technical know-how from education, training, or hands-on experience.
• You pride yourself on a strong work ethic and high standards.

Why Join SerenaGroup?

We're not just growing—we're building something special. As we expand, you'll have the chance to take on new challenges, develop your skills, and make a real impact. We value curiosity, initiative, and people who care about doing great work.

Ready to help shape the future of clinical research? Apply now and let's talk.

Requirements:

Description:

Clinical Trial Lead

Location: Remote

Reports to: Chief Research Officer

The SerenaGroup is growing fast, and we're looking for a Clinical Trial Lead who thrives in a dynamic environment. If you're a natural organizer, love collaborating with smart people, and have a knack for keeping clinical studies on track, you might be the person we're looking for.

What You'll Do

You'll be the operational lead for clinical studies—planning, launching, and running trials from start to finish. You'll juggle vendors, sites, sponsors, and all the details in between, ensuring everything runs smoothly, stays compliant, and gets done on time (and on budget).

Key Responsibilities

• Manage external partners (labs, device companies, service providers) from study start-up through final reports.
• Make sure studies follow all GCP/ICH guidelines and regulatory requirements.
• Own study timelines, budgets, and quality metrics.
• Lead protocol development, informed consent, CRFs, and other study documents.
• Build strong relationships with investigators and site staff to ensure smooth operations and compliance.
• Track and communicate study progress, issues, and mitigation plans to management.
• Handle regulatory submissions (including eTMF, IRB, and ClinicalTrials.gov).
• Run sponsor meetings, provide updates, and manage sponsor billing.
• Oversee site initiation, monitoring, and budgets; act as the key site-sponsor liaison.
• Maintain site metrics and EDC system access.

What Makes You a Great Fit

• You pick up new skills fast and love learning on the job.
• Details matter to you—you spot and fix problems before they snowball.
• You're adaptable and thrive when things change (because they will).
• You take initiative and find ways to improve processes rather than just waiting for instructions.
• You're motivated by meaningful work and share our values.
• You solve problems with logic and creativity.
• You're a team player who builds trust and drives a positive, collaborative vibe.
• You have technical know-how from education, training, or hands-on experience.
• You pride yourself on a strong work ethic and high standards.

Why Join SerenaGroup?

We're not just growing—we're building something special. As we expand, you'll have the chance to take on new challenges, develop your skills, and make a real impact. We value curiosity, initiative, and people who care about doing great work.

Ready to help shape the future of clinical research? Apply now and let's talk.

Requirements:

Qualifications

• Associate degree or equivalent relevant experience.
• Confident with basic math—decimals, fractions, the whole deal.
• Clear and effective communicator, both written and spoken.
• Intermediate reasoning and problem-solving ability.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Medical and Diagnostic Laboratories

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