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We are looking for a Clinical and RA associate.
Primary function of the position:
Under the oversight of the CRA manager (CTM) the person ensures compliance of study conduct with ICH/GCP and country regulations, companys policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Roles and responsibilities:
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Performs remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased
Subjects right, safety and well-being are protected
Conducts site visits including but not limited to initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Supports and/or leads audit/inspection activities as needed
Following the country strategy defined by CRD and CTM, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities
Whiling to travel abroad including US for sites oversights

We are looking for a Medical writer and Regulatory Affairs associate.
Primary function of the position:
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, you would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Essential Job Duties

Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
Contributes to the development of local SOPs. Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Headquarter to align country timelines for assigned protocols.
Provides support and oversight to local vendors as applicable.
Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.

we are looking for Site Monitor in Israel to strengthen our clinical operations team. Work from home and with the flexibility you want. Our monitors have less travel and less workload to maintain work-life balance. We offer long-term projects, world-class technology and training tailored to your individual experience.As a Site Monitor, will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).You will have the opportunity to be a unique sponsor dedicated to one of the top 10 pharmaceutical companies in the world, working on oncology studies that deliver real impact.

As Clinical Development Scientist you will develop the clinical evidence strategy, execution and dissemination in support of assigned CT-AMI programs. You will provide input to the cross-functional team through strong critical scientific thinking to develop innovative solutions for evidence strategy development.

Your role:

Leading development of evidence generation strategies of assigned projects, working within a cross-functional team.

Creating subsequent clinical development / evaluation plans.

Developing strong collaboration with KOLs and Investigators.

Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as Clinical Study Reports and Clinical Evaluation Reports.

Supporting clinical evidence discussions with regulators, advisory boards, associations and societies.

We are hiring a senior data scientist to join Nucleai’s data science team. A cancer patient wants to know that their diagnosis and treatment are determined with the greatest precision and preferably using the most advanced technology. At Nucleai, we bring cancer patients cutting-edge AI-based technology by improving biopsy interpretation with machine learning and creating novel precision medicine technology. Come join our team of experienced AI engineers and world-renowned clinicians, and help us make a difference. At Nucleai, we believe that talents are our most valued asset, and as such, hiring the right people is one of our most strategic missions.
Position Overview The data science team provides the bottom line to our customers – which patients are the best fit for a cancer treatment and what is the chance of success. We do it by analyzing medical images and clinical data, researching spatial features, developing predictive models and applying statistical methods to evaluate the results. Responsibilities:
* Independently lead the data science perspective in any project or assignment – from data mining, through developing new algorithms, to analyzing results and providing professional insights and guidelines.
* Contribute to the team's internal codebase with high-quality code and development standards.
* Augment our knowledge and best practices, adopt relevant SOTA data science methods and practices.
* Work closely with medical doctors, product and project managers, research scientists and software developers to focus your efforts, build new capabilities and provide value to your colleagues and our customers.