Senior Trial Manager

11 Premier Research International LLC; North Carolina; On-site; USD 128,000 - 173,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Senior Trial Manager to lead our clinical trial operations for the FSP team. You will oversee planning, execution, and completion of trials in accordance with ICH/GCP, coordinating a global operations team and ensuring milestone delivery.

The role requires a Bachelor's degree, 10 years of clinical research, including 7 years of global study oversight, excellent English communication, and strong analytical skills.

Qualifications

• Bachelor's degree or international equivalent in clinical, biological, scientific or health-related field.
• 10 years of clinical research experience including 7 years of global study oversight experience.
• Excellent English verbal and written communication skills.
• Strong analytical and organizational skills; ability to work independently with multiple projects.
• Eastern Time Zone preferred.

Responsibilities

• Provide oversight and trial management of planning, execution, and completion of clinical trials per ICH/GCP.
• Coordinate trial operations and team to support milestones and project delivery.
• Develop and review study documents (CRFs, source documents, templates, study plans).
• Select investigative sites and vendors; activate sites on time within budget.
• Lead monitoring team to ensure quality and timely deliverables and address issues.

Skills

Clinical research

Global study oversight

English communication

Analytical skills

Organizational skills

Education

Bachelor's degree or international equivalent

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.

Premier Research is more than a company – it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.