Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 – To enable 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. Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions (AES) optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.At AES we are currently looking to attract a Clinical Research Physician who will look after clinical studies conducted at our Synexus site in Gdansk, Poland.
In this position you will conduct all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes ensuring the medical wellbeing and safety of the participants through the safe performance and execution of the studies. You will drive clinical oversight and quality of the studies at site, or with PI oversight at other sites. You will proactively participate and engage in driving delivery of study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants.
Key roles and responsibilities of the Clinical Research Physician are:
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.To be considered for this exciting opportunity you will need the following skills and experience:
A valid medical degree within the country of practice with at least 2 years working as a licensed physicianValid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work, where applicableA valid ICH GCP certificateAt least 1 year experience working in clinical research with the added advantage of PI responsibility experience, but at least Sub-I experienceExceptional general medical practitioner diagnosis and treatment proficiencyFluent Polish and English languageThorough understanding of medical terminology, drug safety, and interpretation of lab reportsWorking knowledge of scientific concepts related to the design and analysis of clinical trialsThorough critical thinking, decision making, analytical and problem solving skillsExceptional communication skills and ability to work with a cross-functional team to drive resultsDemonstrated ability to influence and collaborate at all levels throughout the organizationExcellent written, verbal and presentation skillsCapable of working well under pressureCapable of effectively prioritizing and managing multiple projectsStrong planning, organizational and project management skillsCapable of managing outside agencies in order to fulfill project objectivesSelf-starter with ability to thrive under pressure in a fast paced environmentSkilled in working with MS Office and InternetOur Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.