Senior Trial Manager - FS
Premier Research
Summary
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.
Job description
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; 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
Requirements
- Bachelor's degree or international equivalent, preferably in a clinical, biological, scientific, or health-related field; or equivalent combination of education, training, and experience
- 10 years of clinical research experience
- 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
- 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
Benefits
- Health Insurance
- Retirement Plans
- Paid Time Off
Company overview
Premier Research International LLC is a global leader in clinical research and consulting services dedicated to helping biotech, specialty pharmaceutical, and medical device innovators transform breakthrough science into life-changing therapies. Founded in 1989, the company specializes in addressing trial complexity, overcoming development hurdles, and demonstrating product value through integrated end-to-end solutions. With deep therapeutic expertise across oncology, hematology, immunology, rare diseases, cell and gene therapy, and women's health, Premier Research leverages innovative technology and operational proficiency to deliver accelerated development timelines. The company operates globally with over 2,000 employees across more than 70 countries, managing clinical trials from preclinical planning through commercialization. Premier Research's mission focuses on turning brilliant ideas into new medical treatments by providing personalized clinical research, product development, and consulting services that help answer unmet patient needs across a broad range of medical conditions.