Research Physician II (Clinical Research Doctor)
Pharmaceutical Product Development (PPD)
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 Research Physician II who will look after clinical studies conducted at our Synexus sites in Katowice and Czestochowa. The role will be based at our Katowice site and will require spending on average 2 days weekly at the Czestochowa site. 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. You will manage and oversee studies simultaneously with the responsibility of PI and sub-I.In this position you will lead the Research Physicians' teams in both locations - Katowice and Czestochowa as well as cooperate closely with the Site Managers there.
Key roles and responsibilities of the Research Physician II 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 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
- A valid ICH GCP certificate
- At least 1 year experience working in clinical research with the added advantage of PI responsibility experience, but at least Sub-I experience
- Exceptional general medical practitioner diagnosis and treatment proficiency
- Fluent Polish and English language
- 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 working with MS Office and Internet
Our 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.
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.
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