Senior Trial Manager

Premier Research

2d•$122,000

About The Position

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.

Requirements

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 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

Responsibilities

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