Senior Trial Manager - FS

Premier Research; United States; Remote; USD 135,000 - 165,000; Full time

Job summary

Premier Research in the United States is seeking a Senior Trial Manager - FS to join our Functional Services Provider team. You will oversee planning, execution, and completion of clinical trials in accordance with ICH/GCP, while coordinating the trial operations team.

The role requires 10 years in clinical research, including 7 years of global study oversight with CROs, and strong English communication. Eastern Time Zone preferred, with a focus on delivering quality, timeliness, and

Qualifications

• 10 years of clinical research experience, including 7 years of global study oversight with CROs on behalf of the sponsor.
• Therapeutic area experience in Rare Dermatology, Immunology, Inflammation and Autoimmune.
• Proven ability to drive a positive customer experience with timely, quality deliverables and ownership.
• Excellent English verbal and written communication skills.
• Strong analytical and organizational skills; able to manage multiple projects in a fast-paced environment.
• Eastern Time Zone preferred.

Responsibilities

• Provides oversight and trial management of planning, execution, and completion of clinical trials in accordance with ICH/GCP.
• Ensures successful management and coordination of all trial operations team members to support milestones and project delivery.
• Oversees development and review of study documentation and may contribute to protocol/study design and informed consent forms.
• Creates and maintains the CMP using approved templates and ensures communication and escalation are incorporated.
• Responsible for site and vendor evaluation and activation of trial sites within time, quality, and budget constraints.
• Leads a monitoring team to ensure quality of reports and timely project deliverables.

Skills

Analytical skills

Organizational skills

English communication

Customer experience

Education

Bachelor’s degree in clinical/biological/health-related field

Job description

Premier Research is looking for a Senior Trial Manager - FS 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 reviewof 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; oversees monitoring visit report review to ensure quality of approved reports

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 with CRO management on behalf of the sponsor
• Therapeutic Area experience in Rare Dermatology, Immunology, Inflammation, and Autoimmune
• 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