Fortrea, a leading global contract research organization (CRO), is dedicated to advancing scientific rigor and innovation in clinical development. With decades of experience, we partner with pharmaceutical, biotechnology, and medical device companies to deliver cutting-edge solutions across over 20 therapeutic areas. Operating in nearly 100 countries, Fortrea is revolutionizing drug and device development to benefit partners and patients worldwide. Join us in our mission to make a global impact by transforming the development process and delivering life-changing therapies faster than ever.
Responsibilities in the Job
As a Medical Data Review Specialist II, you will play a pivotal role in the Global Medical Data Review Team. Your primary responsibilities include:
- Central Medical Review Execution:
- Conduct ongoing reviews for multiple studies as per the Medical Review Plan.
- Communicate findings at the patient and site level.
- Collaborate with the study team to ensure consistency and effectiveness.
- Data Management and Risk Assessment:
- Support critical data and process definition with input from project teams.
- Identify and evaluate safety signals through data analysis and signal detection systems.
- Contribute to risk assessment tools related to medical review.
- Planning and Implementation:
- Draft Central Medical Review Configuration Plans and Central Monitoring Plans.
- Maintain and update plans throughout the study lifecycle.
- Reporting and Inspection Readiness:
- Prepare and distribute quality reports during study conduct and at close-out.
- Ensure inspection readiness and support regulatory authority inspections as needed.
- Mentorship and Process Improvement:
- Mentor new team members and provide training on project processes.
- Propose and implement process improvements for greater efficiency.
Qualifications
To excel in this role, you should possess:
- A background in a relevant scientific or clinical discipline.
- Experience in medical data review, central monitoring, or related clinical trial activities.
- Familiarity with electronic data capture (EDC) systems and medical review platforms.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
Skills
- Expertise in medical data review and clinical trial processes.
- Proficiency in data visualization and critical data evaluation.
- Knowledge of risk assessment and regulatory compliance.
- Ability to provide actionable insights and solutions.
- Strong organizational and time management skills.