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The Clinical Project Lead will responsible for day to day execution of the companys global clinical trial plan and will provide hands on support. The Clinical Project Lead will help supervise the different phases of clinical trials. The Clinical Project Lead will monitor and organize the Clinical Data from the Company's various studies in ensuring compliance with regulatory requirements and company SOPs.
Duties and Responsibilities -Manage and execute sponsored clinical studies projects in Israel and abroad.
Participate in the development of study protocols, study documents and Case Report Forms Clinical database administration.
Assess the clinical research sites patient recruitment and maintain an enrollment status table.
Manage additional projects as assigned by manager 
Working hours: Full Time Position. Office location is in Ramat Gan. Reports to: Regulatory and Clinical Affairs Manager Interface with: R&D, Marketing, Regulatory and QA 
Travel Requirements: 
50%- In Israel & abroad.

Required Clinical Research Scientist.
job id:2019-1488

Required Clinical Trial Manager.
job id: 2019-1465
Under supervision may participate/lead in CRA project-specific training.
Supports preparation and development of materials related to the training and presentations for Investigator Meetings.
Facilitates CRA project meetings.
Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct to the appropriate study CPM.
Track and report on progress of the study metrics, including site activation, patient enrollment and monitoring visits.
Ensures that all sites are provided supplies in accordance with study expectations.
Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with the CPM.
Develop PSV /SIV/IMV presentation and other training tools and training materials in support of the project.
May be responsible for ensuring that monitoring visits are performed in accordance with the protocol, monitoring plan, and applicable company SOPs.
Under supervision may be responsible for operationalizing clinical protocols at the site level and ensuring appropriate SOPs are being followed for each process, depending on the study
May participate in eCRF User Acceptance Testing (UAT) and the creation of eCRF completion guidelines and ensuring site level access to eCRFs throughout the conduct of a study.
Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team.
Work with Lead CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol and regulations.
Liaise with Lead CRA regarding data entry/data quality concerns and alert them of any issues prior to the next scheduled monitoring visit.
Assist with study start-up activities including development of the first draft of the ICF.
Assist with the review of protocol, protocol amendments, ICF and CSR documents as required.
Agenda distribution & minute taking for internal study team meetings.
Up to 20% domestic and/or international travel may be required.

Required Medical Science Liaison (EU).
Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
Identify and develop relationships with community/academic thought leaders along with treatment advocates on a local, regional, and national level.
Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance.
Ensure a strong medical and scientific presence for our company in key academic centres by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to our company.
Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant medicines, to support their safe, effective and appropriate use.
Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.).
Serve as our scientific representative to the medical community and facilitate the appropriate exchange of scientific information.
Provide clinical and economic value information to payers and formulary decision makers.
Utilize approved resources to address customer needs, ensuring they are in compliance with all guidelines and regulations.
In partnership with clinical operations, support trial awareness, enrollment, and identification of potential sites/investigators for clinical trial participation.
Serve as the key liaison for all aspects of investigator sponsored research.
Facilitate medical and scientific field intelligence for example, competitor research and medical strategies, educational activities, structure and function.
Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform our strategic priorities and initiatives.
Communicate therapeutic market trends which may impact our pipeline.
Participate and support advisory boards and steering committees.
Lead and/or participate on committee/project teams which support MSL strategies as delegated by MSL leadership.
Gain feedback through field interactions with HCPs to uncover collaboration opportunities and pair customers unmet needs with available internal resources.
This position is a field based international role as such the person is expected to be able to travel and be active with in field duties 70% of the time.

We are looking for a Clinical Trials Lead to join our product team and manage our new and ongoing clinical trials. 
As a Clinical Trials Lead you will be responsible for directing the process of clinical trials by employing effective organizational and clinical strategies and reviewing the results using rigorous clinical procedures. 
You will often interact with clinical staff, product owners and the regulatory team to design the studies and then analyze the results. This is the perfect role for an experienced clinical lead, who is looking to step into a leadership role and assume end to end responsibility of the clinical domain in a company that is trailblazing its category. 
Role & Responsibilities: 
* Lead the companys clinical studies activities. 
* Assume end-to-end responsibility of clinical studies - from design to analysis and submission. 
* On the ground, execution of studies, mainly in the U.S. 
* Prepare protocols and case forms and finalize monitoring and data management options. 
* Work closely with both the product and regulatory teams to turn the clinical studies into product and clinical claims. 
* Manage, train and direct other team members to facilitate the studies.