דרושים » רפואה ופארמה » Senior Clinical Research Associate - Isreal - Oncology - FSP

Are you ready to lead and inspire? As a Local Study Associate Director (LSAD), you will lead Local Study Teams (LSTs) at the country level to deliver clinical studies within agreed resources, budget, and timelines. You will ensure compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading LSTs, you may perform site monitoring as needed to support the flexible capacity model. Your role will be crucial in identifying sites, performing site qualifications, setting up, initiating, monitoring, closing, and archiving documentation.

Accountabilities
Overall responsibility for study commitments within the country and timely delivery of data to required quality.
Lead Local Study Team consisting of CRA(s), CSA(s) for assigned study/studies.
Optimize the performance of Local Study Team(s) ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
Ensure high-quality clinical and operational feasibility assessments of potential studies.
Coordinate site selection by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.
Ensure timely submission of application/documents to EC/IRB and Regulatory Authority.
Prepare and maintain accurate study budgets in AZ clinical studies financial system.
Prepare local Master CSA (including site budget) and amendments as needed.
Prepare country level Master Informed Consent Form (MICF) and subsequent site level ICFs.
Collect and verify trial essential documents prior to study start.
Plan and coordinate local drug activities.
Set up and maintain the study in CTMS at study country level.
Oversee monitoring activities from site activation through to study closure.
Review monitoring visit reports and advise monitors on study-related matters.
Perform co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Identify risks and facilitate resolution of complex study problems.
Organize regular Local Study Team meetings.
Maintain good personal relationships with all Local Study Team members, sites staff, and global stakeholders.
Report study progress/update to the Global Study Associate Director/Global Study Team.
Contribute to patient recruitment strategy.
Develop and review risk management plan on country study level.
Communicate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters.
Plan and lead National Investigator meetings. Assist in forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies.
Ensure relevant systems are set-up, updated, and access is organized at country level.
Ensure accurate payments related to the study are performed according to local regulations and agreements.
Participate in training and coaching new members of the Local Study Team.
Ensure completeness of the eTMF and maintain it Inspection Ready.
Ensure all study documents are ready for final archiving and completion of local part of the eTMF.
Plan and lead activities associated with audits and regulatory inspections.
Provide input to process development and improvement.
Provide regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
Update Line Managers about the performance of the CRAs/CSAs.
Ensure compliance with local policies and code of ethics.
Provide feedback on research-related information useful for the local market.
Collaborate with local Medical Affairs team.
Support SMM in different initiatives as agreed with SMM Line Management.

Join our dedicated Clinical Research team as a Clinical Research Associate (CRA). In this role, you will have local responsibility for the delivery of studies at allocated sites and will be an active participant in the local study team(s). You will work in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. This is your chance to strengthen our pipeline and make a meaningful impact on patients' lives!

Accountabilities:
As a CRA, you will contribute to the selection of potential investigators, train, support and advise Investigators and site staff in study-related matters, and ensure that study sites are inspection ready at all times. You will also be responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, ensuring compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

We are seeking a Clinical Operation Manager to oversee and manage the execution of clinical trials, ensuring compliance with regulatory requirements and alignment with company objectives. This role is pivotal in coordinating clinical operations, supporting global clinical trial execution, vendor management, and data integrity to facilitate successful regulatory submissions.

The Clinical Operation Manager will work closely with internal teams, CROs, regulatory bodies, and external partners to ensure that all clinical trials are conducted efficiently and in compliance with FDA and international regulations.

Key Responsibilities
In collaboration with Head of clinical operations and/or Medical Director,
responsible for comprehensive study management
Lead core team meetings for assigned studies, ensuring goals and deliverables are defined, and issues, decisions, risks, and actions are appropriately tracked
Responsible for managing project-specific vendors, including Study Committees, CRO/ARO, Core Labs, and DSMBs/CECs.
Oversee and support the development of key study documents including, but not limited t,o study protocols and related amendments, study plans and procedure manuals, project tools, training materials, Informed Consent Forms, and Clinical Study Reports.
Accountable for the conduct of clinical study following the approved project plans, budgets, SOPs, and applicable regulations
Support analysis and development of action plans for investigational sites, vendor management, non-compliance, and administrative issues

The internship program provides learning experience, mentoring and valuable work experience in the field of clinical trials. We provide our interns the opportunity to work on meaningful assignments and make sure that they gain real world experiences (in the areas of Regulatory & Finance and Supply & CRA support).



This program provides comprehensive trial and site administration experience. Under the oversight of the COM Lead/COMs and CTCs, the person prepares, collates, distributes and archives clinical documents. The Interns supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

* Internship duration up to 12 months *

Responsibilities:

Trial and site administration:

Track (e.g. essential documents) and report (e.g. Safety Reports)

Ensure collation and distribution of study tools and documents

Update clinical trial databases (CTMS) and trackers

Clinical supply & non-clinical supply management, in collaboration with other country roles

Manage Labeling requirements and coordinate/sign translation change request

Document management:

Prepare documents and correspondence

Collate, distribute/ship, and archive clinical documents, e.g. eTMF

Assist with eTMF reconciliation

Execute eTMF Quality Control Plan

Update manuals/documents (e.g., patient diaries, instructions)

Document proper destruction of clinical supplies.

Prepare Investigator trial file binders

Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

Obtain, track and update study insurance certificates

Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

Publish study results for GCTO and RA where required per local legislation

We are looking for an experienced Clinical MD to manage and oversee our clinical development plan and the medical aspects of advanced-stage clinical trials. In this role, the Clinical MD will address medical inquiries throughout the trial process, contribute to protocol development, and participate in ongoing trial monitoring, including preparing Clinical Study Reports (CSR).

Additionally, the Clinical MD will work closely with internal and external stakeholders to shape the clinical strategy, helping to define the optimal trial path and medical indications required for FDA approval.

Key Responsibilities
Provide medical consultation and support throughout advanced clinical trials, demonstrating a deep understanding of the clinical research process.
Contribute to developing clinical trial protocols, ensuring scientific accuracy and full regulatory compliance.
Oversee the execution of clinical studies, including process monitoring and preparation of Clinical Study Reports (CSRs) summarizing key findings.
Participate in defining the optimal types of trials and clinical indications to support a strong case for FDA approval.
Manage and support the execution of complex clinical programs, including multiple concurrent trials designed to generate comprehensive and robust data.
Supervise small-scale pharmacological studies focusing on pharmacokinetic (PK) and pharmacodynamic (PD) parameters.
Lead preparations for regulatory meetings (e.g., IND), including analysis and interpretation of preclinical pharmacology and PK/PD data.
Define clinical trial objectives and endpoints as part of the overall strategy, ensuring alignment with both medical standards and regulatory expectations.

We seek a highly motivated and experienced Senior Researcher to join our dynamic team. This role is pivotal in advancing our companys collaboration with leading academic institutions and healthcare organizations globally and helping our company deliver cutting-edge insights that support business growth and B2B opportunities. The ideal candidate will contribute to the entire research lifecyclefrom study design to publication.
Responsibilities
Research Collaboration:
Work closely with universities, academic institutions, and research teams worldwide to design, execute, and manage collaborative studies focused on metabolic health and performance.
Study Design & Execution:
Develop robust study designs tailored to explore metabolic health, fitness optimization, and related areas. Oversee the execution of studies, ensuring alignment with scientific standards and ethical guidelines.
Data Analysis & Insight Generation:
Analyze study and retrospective data to extract actionable insights that advance metabolic research and support our company's product development, marketing, and B2B initiatives.
Publication & Thought Leadership:
Lead the drafting and submission of high-quality manuscripts to peer-reviewed journals.
Innovation & Product Integration:
Collaborate with cross-functional teams to translate research findings into innovative product features, user education materials, and growth strategies.
Strategic Input:
Provide strategic insights to enhance our companys position as a metabolic health research leader. Identify new research opportunities that align with business goals.
Why Join us?
Be part of a company that is redefining metabolic health through groundbreaking research and technology.
Collaborate with top-tier universities and institutions worldwide.
Work in a fast-paced, innovative environment that values curiosity, creativity, and impact.
Contribute to insights that drive global health and wellness improvements.

We are looking for a nonclinical lead with a toxicology and nonclinical drug development background to join our team. The role involves managing all nonclinical studies, scientific review of study plans, regulatory document review and writing, and participation in strategic discussions.

Key Responsibilities
Management and monitoring of all non-clinical studies
Review and oversee nonclinical studies Provide expert evaluation and guidance on nonclinical study plans and reports.
Regulatory support Review regulatory documents as a nonclinical SME and contribute to regulatory writing (IB, submission documents) as needed.
Strategic input in nonclinical development Offer expert guidance on nonclinical development strategies.
Participation in team meetings provide updates on study monitoring
Expert consultation Take part in dedicated expert meetings as needed.

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! The position includes all aspects of quality assurance for all companies in the group. Job includes: Drafting new SOPs and updating existing SOPS and reports according to GMP and GDP regulations. Build and follow up work processes, set yearly training and conduct continuous training sessions for employees and suppliers. Document training. Conduct validation and monitor prevention and improvement activities (CAPA). Assist in preparing for inspections, executing internal auditing and partner audits as needed. Qualify suppliers, manage investigations and deviations. Risk management and support regulatory and operations divisions. Prepare specified yearly quality reports and be of assistance to manager in any way required. Quality activities are not inspections, rather supervision. The purpose is to coordinate the company's management and regulatory efforts in a specific field.

Responsibilities:

* Ensure that the quality assurance system is implemented in a way that the approved activities can be managed.
* Ensure precision and quality where listed and approve inspected documents.
* Supervising that employee training is implemented and maintained.
* Handle changes and deviations according to managers' requirements. Implement preventative and correction measures when necessary.
* Ensure implementation of periodic management survey.
* Ensure implementation of risk management.
* Ensure that suppliers and partners are approved and qualified.
* Approve every activity performed by sub-contractor that may indicate the quality of the
* products.
* Implement and ensure that internal inspections are carried out regularly and according to a set plan and ensure that corrective actions are set up after inspections.
* Keep account of all assignments carried out for person/company.
* File all relevant documentation.
* Carry out any task requested by superior.
* The role includes leading, coordinating and performing, validation and calibration activities in the warehouse areas and distribution-- vehicles. Occasionally, early work hours are require

were passionate about simplifying healthcare by automating the accurate interpretation of clinical language.
Our interdisciplinary team has developed innovative technology that understands clinical language, offering a groundbreaking way to analyze and decode medical records into clear, concise, and actionable information. This ensures that clinical and administrative teams can dedicate more time to patient care.

the future is bright. Our engine currently processes over six million charts annually across more than 300 emergency departments and urgent care settings in the U.S. Backed by top-tier VCs, we are growing rapidly, with offices in NYC and Tel Aviv.

Role and Responsibilities:
looking for a Medical Developer to join our growing R&D group, reporting to our Chief Architect. The ideal candidate will play a key role in developing new sub-engines for emerging projects and clients. This role involves maintaining and improving product quality, upholding high coding standards, and driving customer satisfaction.

Success in this role requires strong project management experience, analytical and problem-solving skills, cross-team collaboration, and a flexible, solution-oriented mindset in a dynamic environment.

As a Medical Developer, you will:
Analyze and understand clients business objectives and needs, designing Clinical Language Understanding engine accordingly.
Lead new specialty projects, guiding technical development, identifying and recommending improvements, and proactively resolving alerts and escalated issues.
Collaborate with multidisciplinary teams, including customer success, R&D (software engineers, linguists, medical doctors, product managers, data analysts, and medical coders).

A leading biotech company, located in Rehovot, that uses Machine Learning and AI technologies to create superior drugs for cancer and autoimmune disorders by programming antibodies to become dynamic functional switches that affect biology in new ways.
We are seeking a motivated Ph.D. Scientist to join one of our leading programs as a key player in the Drug Discovery department and contribute to the discovery of a novel therapeutic.
As a R&D Scientist, you will significantly contribute to the establishment and implementation of in-vitro antibody characterization essays using cell-based assays and deeper immunological experiments. Key responsibilities:
* A core member of a discovery project team
* Designing and execution of various biological research experiments: cancer cell lines, T and NK cells-based assays
* Developing flow cytometry, immunophenotyping, and other immunological assays
* Analyzing data, documentation, and presentation of scientific and experimental work.
* Identify, suggest, and design mechanisms of action studies (in vitro & in vivo).
* Meeting project goals and timelines.