Medical Specialist

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:

• The Medical Specialist (MPs) is responsible for supporting members of the medical team (i.e. Medical Monitors (MM), Medical Scientists (MS), and other functional leads) to perform and execute all project deliverables associated with a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements.
• Partners with the MM and MS across all therapeutic areas at Premier Research to support overall project delivery through coordination and oversight of broad study needs. This may include tracking of safety data, document maintenance in accordance with applicable study regulations (including keeping document logs and collections) and providing planning and scheduling assistance for internal and external activities, and FDA regulated documentation.
• Independently responsible for managing and overseeing the 24/7 staff physician tracker and process in accordance with FDA regulation, including: managing vendor relationship, liaising with associated therapeutic area/BU, conducting test calls, maintaining associated SOPs, triaging medical information.
• Collects study-specific data reports, compiling specified documents, and modifying Premier Research-approved templates to study-specific and protocol needs.
• Provides document formatting and the display of select data/information or summaries, as needed.
• Assists with 21 CFR Part 11 document compliance and facilitates document handling for the MM, as well as tracks and supports the capture of these documents into the Trial Master File (TMF). Supports other activities for TMF documents for the medical team under specifications of the MM.
• Provides project template customization including Word documents and PowerPoint slide decks to the specification of the medical team.
• Develops and independently maintains tracking tools for select safety concerns to the specifications of the lead MM for individual studies, as well as tracking of study participants during the pre-enrollment eligibility process (PEER) as applicable.
• Assists with the Data Monitoring Committee/Data and Safety Monitoring Board/Safety Review Committee (DMC/DSMB/SRC) meeting planning and preparations for the medical team, following the specifications of and under the supervision of the MM/MS, and supports recurring medical data reviews and DMC/DSMB meetings with document collection and distribution to MM/MS.
• Supports all therapeutic areas in the setup, development, and maintenance of study specific data displays using Clinical Trial Management Software. Assists MM/MS in facilitating team communications and maintaining documentation internally and externally. Ensures effective communication by scheduling internal and external team meetings.
• Develops and independently maintains Medical Affairs team study tracker, proactively identifies gaps, and promptly alerts the MM/MS teams to critical issues.
• Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures. Participates in corporate initiatives and actions that ensure the continued success of the company.

What we are looking for:

• Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience or Bachelor's degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred.
• Strong computer skills in MS office suite required.
• Basic knowledge of ICH/GCP regulations.
• Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures.
• Basic knowledge of project management terminology and guidelines a plus.