Clinical Review Specialist - EDS (Day Shift & Fully Remote)

Employment Type and Schedule

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description Overview

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our Clinical Data Management team supervises all data collected in a clinical trial. This work spans the design and build of the EDC database, ingestion of all digital and vendor data sources, comprehensive data review and validation with a focus on high quality delivery of clinical trial data. We work closely with our project teams and customers across all therapeutic areas incorporating innovative technology and best practices to help our customers deliver life-changing therapies.

• Office Location: Seven/NEO Building, Bonifacio Global City, Taguig City, Philippines
• Shift Schedule: Day Shift - flexible hours (8:00 AM to 5:00 PM)
• Work Arrangement: Fully Remote

Discover Impactful Work

The Clinical Review Specialist reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to collaborate closely with colleagues in other functional groups as required, and to connect with management for all data review activities within their allocated studies.

A Day in the Life

• Understands project protocols and the Data Validation Manuals (DVMs) and applies relevant components to daily tasks.
• Reviews patient data and generates and manages manual queries in accordance with the Manual Data Review Plan (MDRP) in the DVM and Client expectations.
• Identifies data issues and works with the Early Development Services team and study sites to resolve.
• Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time.
• Provides support, guidance and direction on clinical data review to the Clinical Data Management (CDM) project team.
• Performs assigned clinical review and data management activities independently and efficiently, with attention to quality.

Keys to Success

Education

• Bachelor's Degree Graduate in any Life Science or Healthcare-related Courses (i.e. Pharmacy, Nursing, Medical Technology, Biology, etc.)

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills, Abilities

• Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs and client expectations.
• Excellent understanding of pharmaceutical/clinical/medical terminology.
• Skilled in interactive computer programs.
• Good written/verbal communication skills with a strong command of English language and grammar.
• Excellent organizational, analytical/problem solving skills and attention to detail.
• Ability to work productively with minimal supervision.
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data.
• Strong customer focus and excellent interpersonal skills.
• Proven flexibility and adaptability when working in a team and independently using excellent judgment in making decisions.