Senior Trial Manager

Premier Research; United States; On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research in the United States seeks a Senior Trial Manager to join our Functional Services Provider (FSP) team. You will oversee planning, execution, and completion of clinical trials in accordance with ICH/GCP, ensuring milestones and quality.

This role requires 10 years of clinical research experience, including 7 years of global study oversight. You will lead a trial operations team, coordinate documentation, sites, and vendors, and drive on-time deliverables.

Qualifications

• Bachelor’s degree in clinical/biological/scientific health field or equivalent
• 10 years of clinical research experience including 7 years of global oversight
• Proven ability to deliver quality, timely deliverables and ownership
• Excellent English verbal and written communication
• Strong analytical and organizational skills; able to manage multiple projects
• Eastern Time Zone preferred

Responsibilities

• Oversee planning, execution, completion of clinical trials per ICH/GCP
• Coordinate trial operations team to support milestones and delivery
• Develop and review project documents like CRFs, source templates, study plans
• Create and maintain CMP with templates; ensure proper communication and escalation
• Oversee site and vendor evaluation/selection and trial site activation
• Lead monitoring team to ensure quality and timely deliverables

Skills

Clinical research experience

Global study oversight

Customer experience

English communication

Analytical and organizational skills

Time zone: Eastern Time Zone

Education

Bachelor’s degree in clinical/biological/scientific health field

Job description

Premier Research is looking for a Senior Trial Manager to join our Functional Services Provider (FSP) team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing

• Provides oversight and trial management of the planning, execution, and completion of clinical trials in accordance with all applicable regulations and guidance including ICH/GCP
• Ensures successful management and coordination of all members of the trial operations team, to support milestone achievement and overall project delivery
• Oversees and facilitates the development and review of project documentation, such as Case Report Forms, Source Documents, templates and study plans. May contribute to the review of protocol/study design, informed consent forms, and be a reference point for CRAs and investigative sites
• Creates and maintains the study specific clinical monitoring plan (CMP) utilizing approved templates; ensures effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
• Responsible for clinical operations oversight in the evaluation and selection of investigative sites and vendors (e.g. – central labs, IVRS, etc.), and drives the successful activation of trial sites according to time, quality/scope, and budget parameters
• Leads, drives, manages and actively monitors the clinical monitoring team with a focus on quality and timely project deliverables. Reviews data reports to ensure monitoring optimization; performs monitoring visit report review/management; and addresses quality issues with the appropriate team members as needed

What We Are Searching For

• Bachelor’s degree, or its international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field; or equivalent combination of education, training, and experience
• 10 years of clinical research experience, including 7 years of global study oversight experience. Alternatively, must have proven experience in all primary job functions
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Demonstrates excellent English verbal and written communication skills
• Strong analytical and organizational skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Eastern Time Zone preferred

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $150,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status