• 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

• Must have experience managing open label extension studies in Rare Disease

• 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.