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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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
• Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

Physical Requirements / Work Environment

• · Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance

What we offer

At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!