Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
Summarized Purpose:
Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Drives clinical oversight and quality of the studies at site, or with PI oversight at other sites. Proactively participates and engages in driving delivery of study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants. Manages and oversees studies simultaneously with the responsibility of PI and sub-I.
Essential Functions
- Carries out clinical evaluation and assessment of participants to ensure eligible participants are recruited and monitored for safety and adherence.
- Attends Site Initiation Visits (SIV), Pre-Selections Visits (PSV) and Investigator meetings as required.
- Participates in recruitment initiatives and strategy development to ensure targets are achieved; ensuring recruiting studies enroll according to plan within timelines and targets.
- Reviews enrolment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.
- Interprets protocols and IB.
- Manages and reviews IVRS, CRF/EDC, if applicable.
- Oversees management of investigational medical product (IMP).
- Oversees multiple studies and/or studies with higher numbers.
- Completes documentation for PI handover.
- Cares for and protects the safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study.
- Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the requirements as per protocol, SOP/COP ICH and local GCP guidelines and regulations
Qualifications:
Education and Experience:
- A valid medical degree within the country of practice with at least 2 years working as a licensed physician
- Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work, where applicable
- Exceptional general medical practitioner diagnosis and treatment proficiency
- At least one-year experience working in clinical research, or comparable research/clinical expertise to demonstrate the ability to work in clinical trials
- A valid ICH GCP certificate(can be obtained after employment)
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Thorough understanding of medical terminology, drug safety, and interpretation of lab reports
- Working knowledge of scientific concepts related to the design and analysis of clinical trials
- Thorough critical thinking, decision making, analytical and problem solving skills
- Exceptional communication skills and ability to work with a cross-functional team to drive results
- Demonstrated ability to influence and collaborate at all levels throughout the organization
- Excellent written, verbal and presentation skills
- Capable of working well under pressure
- Capable of effectively prioritizing and managing multiple projects
- Strong planning, organizational and project management skills
- Capable of managing outside agencies in order to fulfill project objectives
- Self-starter with ability to thrive under pressure in a fast paced environment
- Skilled in Word, Excel, and PowerPoint and proficient with the Internet
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- 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.
