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Skills: Medical Monitoring, Clinical Research, Pharmacovigilance, Clinical Development Planning, Regulatory Compliance
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Planning
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Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Planning
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Full-time
postgraduate degree
Posted 8d ago
~40 hrs/week
Responsibilities
Provide medical expertise to clients and project teams to ensure the safety of study participants and the accuracy of clinical data. Collaborate on the preparation of clinical development plans, protocols, and regulatory documents while managing program risks.
Requirements
Requires a Medical Doctor degree and prior experience in clinical research, with board certification in a major therapeutic area being desirable. Must possess strong leadership skills and familiarity with local health authority interactions and GCP/ICH guidelines.
Full job description
Company Description
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.
We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.
Job Description
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
Full-time employment based in Singapore
Responsibilities:
Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
Review and analysis of clinical data to ensure the safety of study participants in clinical studies
Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
Address safety issues across the study from sites and the study team
Participate in bid defense meetings
Assist in Pharmacovigilance activities
Identify Program risks, and create and implement mitigation strategies with Clinical Operations
Ability to organise and lead clinical development advisory boards and safety monitoring boards
Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines
Review and sign off clinical documents with respect to medical relevance
Qualifications
Medical Doctor degree
Board certification in Gastroenterology is preferred
Clinical experience in major therapeutic area (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine) is desirable
Prior experience in Clinical Research
Familiar and comfortable with clinical concepts, practices and local regulations regarding clinical research trials experience with local health authority interactions leading to drug approval strongly preferred
Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
Must possess excellent leadership, communication, presentation, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance
Proficiency with MS Office applications
Additional Information
Join our highly dedicated team of clinical research professionals with 250+ Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists.
Related keywords
Medical MonitorCROClinical TrialsOncologyInfectious DiseaseGastroenterologyHematologyInternal MedicinePharmacovigilanceICHGCPClinical Study ReportsInvestigator BrochuresData Safety Monitoring BoardsRegulatory AgenciesClinical Development Plans
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3
How many Healthcare jobs are open in Singapore, Singapore right now?
There are currently 968 open healthcare positions in Singapore, Singapore listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Singapore, Singapore?
Companies currently hiring include SingHealth, Thermo Fisher Scientific, GSK, National Institute of Education, Singapore, Sanofi, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Singapore, Singapore?
Yes — 122 of the 968 open healthcare positions offer remote or hybrid work (19 remote, 103 hybrid).
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