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Director, Clinical Operations |
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Category: |
Life Sciences, Clinical Research, Pharmacy/Pharmacology
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Education: |
Bachelors |
Position type: |
Full Time |
Experience: |
10+ years |
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Area(s) of expertise desired: |
Clinical Research, Regulatory Affairs, Start-Up
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Description: |
The Role:
Reporting to the Senior Director, Clinical Operations & Site Head, the Director of Clinical Operations will be responsible for leading and managing the execution of Eloxx’s clinical studies from protocol inception through study closure. This key role will manage, plan and execute clinical studies, including creating and managing study timelines, budgets and study management plans in a full out-sourced model to ensure that our corporate goals. This is a great opportunity for visibility and professional growth; the Director of Clinical Operations will manage a team of Clinical Project Managers and partner with the Senior Director to represent the Clinical Operations team cross-functionally and with key stakeholders.
Responsibilities:
• Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
• Oversees the day-to-day clinical operations through a team of Project Managers with a focus on vendor management(e.g., CRO, laboratories), monitoring clinical trial recruitment rate, and coordination of activities.
• Executes high quality, integrated cross-functional plans for the project/clinical trial.
• Represent Clinical Operations in cross-functional teams, clinical meetings and regulatory meetings. Provide regular status updates to senior management.
• Provide strategic input and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality, and risk mitigation.
• Responsible for the oversight of protocols development; protocol preparation, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial.
• Accountable for internal clinical trial files and documents.
• Participates and manages investigator meetings and follow up.
• Travels for meetings and site visits when necessary.
• Maintains proper communications with other departments to ensure good relationships in connection with ongoing set up and progress throughout trial planning and execution.
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Requirements: |
Competencies Include:
• Complex problem-solving abilities with a focus on accomplishing assigned goals and objectives in a dynamic environment.
• A team player who is able to effectively and flexibly lead cross functional teams across diverse cultures, backgrounds and styles.
• Excellent communications and presentation skills, able to effectively inform key stakeholders and management of the status, issues and solutions.
• Strong organizational and planning skills are required, with a proven ability to manage budgets and timelines.
• Detail-oriented, a self-starter and comfortable with broad responsibilities in a fast-paced, small company environment.
• Excellent computer skills, proficiency with project management software tools.
• Prepared to travel internationally (US and EU) for approximately 7-10 days once every 2-3 months.
• Flexibility to work US hours a few times a week.
Experience:
• Minimum of 10 years’ experience in the pharmaceutical industry, with 5-7 years’ direct experience in planning and managing global clinical trials.
• Strong people management skills with experience managing at least 2 or 3 direct reports required.
• Strong bi-lingual verbal and writing skills in English and Hebrew required.
• Extensive experience managing clinical programs, CROs, budgets and timelines.
• Regulatory/EMA/FDA experience.
• Good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines.
• Solid understanding of pharmaceutical clinical development processes and have experience with clinical monitoring.
• Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues.
• Strong leadership skills and self-awareness.
• Experience presenting to a varied audience, including investors and upper management.
Education:
• Bachelor’s Degree or equivalent biologic science degree is preferred.
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Home Phone Agent - patients screening for clinical trials |
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Category: |
Clinical Research, Sales/Marketing
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Education: |
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Position type: |
Part Time |
Experience: |
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Area(s) of expertise desired: |
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Description: |
nRollmed agency - online patient recruitment & retention for clinical trials, is seeking for professionals to conduct phone pre-screening of potential patients considering participation in clinical trials.
This job is suitable for those looking for a partial position and wishing to work from home.
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Requirements: |
Requirements:
* English as a mother tongue
* Working on US time zone
* ability to build trust and confidence over the phone
* active listening and empathy
* administrative capabilities
* medical related education / experience - an advantage.
* experience in clinical trials - an advantage
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Home Phone Agent - patients screening for clinical trials |
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Category: |
Clinical Research, Sales/Marketing
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Education: |
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Position type: |
Part Time |
Experience: |
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Area(s) of expertise desired: |
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Description: |
nRollmed agency - online patient recruitment & retention for clinical trials, is seeking for professionals to conduct phone pre-screening of potential patients considering participation in clinical trials.
This job is suitable for those looking for a partial position and wishing to work from home.
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Requirements: |
Requirements:
* English as a mother tongue
* Working on US time zone
* ability to build trust and confidence over the phone
* active listening and empathy
* administrative capabilities
* medical related education / experience - an advantage.
* experience in clinical trials - an advantage
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Patient recruitment for clinical trials |
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Category: |
Clinical Research, Clerical/Administrative, Sales/Marketing
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Education: |
Associate |
Position type: |
Part Time |
Experience: |
No experiece |
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Area(s) of expertise desired: |
Administration, Clinical Research, Communications, Customer Service, Marketing, Sales, Technical Services
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Description: |
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nRollmed - online patient recruitment & retention, is seeking for professionals to conduct phone pre-screening of potential patients considering participation in clinical trials.
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Requirements: |
high marketing capabilities
ability to build trust and confidence over the phone
active listening and empathy
availability during different hours of the day
administrative capabilities
experience in clinical trials - an advantage
familiarity with ophthalmology/Optometry - an advantage.
This job is suitable for those looking for a partial position and wishing to work from home.
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Patient recruitment for clinical trials |
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Category: |
Clinical Research, Clerical/Administrative, Sales/Marketing
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Education: |
Associate |
Position type: |
Part Time |
Experience: |
No experiece |
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Area(s) of expertise desired: |
Administration, Clinical Research, Communications, Customer Service, Marketing, Sales, Technical Services
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Description: |
nRollmed - online patient recruitment & retention, is seeking for professionals to conduct phone pre-screening of potential patients considering participation in clinical trials.
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Requirements: |
high marketing capabilities
ability to build trust and confidence over the phone
active listening and empathy
availability during different hours of the day
administrative capabilities
experience in clinical trials - an advantage
This job is suitable for those looking for a partial position and wishing to work from home. For more details please contact Hagit Nof at 054-4708077, hagit.nof@nrollmed.com
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CRA |
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Category: |
Clinical Research
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Education: |
Bachelors |
Position type: |
Full Time |
Experience: |
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Area(s) of expertise desired: |
Clinical Research
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Description: |
• Responsible for all administrative support
in the clinical research department
• Involved in the execution of clinical studies and documentation of findings according to established company guidelines
• Responsible for ongoing data entry using IT systems, as well as other administrative supports
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Requirements: |
• A degree or equivalent in a scientific or healthcare discipline.
• Certified Clinical Research Associate (CRA)
• Knowledge and understanding of medical facilities.
• Exceptional interpersonal skills.
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Clinical and Quality Assurance Manager |
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Category: |
QA - Quality Control, Clinical Research
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Education: |
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Position type: |
Full Time |
Experience: |
5 years |
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Area(s) of expertise desired: |
Clinical Research, Medical Device, Orthopedics, Quality Assurance, Start-Up
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Description: |
Manages all clinical aspects of a clinical study, including:
•Assesses operational feasibility and recommends study execution plan; participates in site monitoring visits as appropriate.
Select countries and sites for trial participation; develops relationships with K.O.L and site staff; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate;
•Design clinical trial protocols;
•Prepares/reviews site study documents
•Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.)
•Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs:
Manages all aspects of quality assurance activities including:
•Ensure compliance with FDA and other regulatory affairs
•Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
•Establish quality assurance and quality control inspection and testing procedures
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Requirements: |
•Minimum 5 years clinical trial management experience in a medical device company - Mandatory
•Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for clinical trials is required;
•International clinical trial experience
•Minimum 2 years Quality Assurance experience in a medical device company - Mandatory
•Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements
•Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
•Experience working with subcontractors
•Excellent English - written and verbal
•Excellent communication and organizational skills, along with problem solving,
Travel- Travel abroad required per week, per month
Location: Misgav Industrial Park
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Customer Relations Manager |
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Category: |
Clinical Research
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Education: |
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Position type: |
Full Time |
Experience: |
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Area(s) of expertise desired: |
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Description: |
The customer relations manager will report to the CEO, handle customer accounts and provide guidance on enhancing customer relationships. Duties will include:
Be the liaison between the Company and its customers.
Work closely with the Company sales reps, distributors and service centers to (1) understand the customer environment, including customer influences, decision-makers and business challenges, and (2) support sales by orchestrating sales activities and communicating potential problems to the CEO.
Lead the implementation of a CRM system.
Creating and retaining customer loyalty and preference by establishing rapport with customers, planning and developing customer-focused programs, overseeing the resolution of customer concerns, and facilitating the delivery of goods or services to the customer.
Focus on customer service quality and product differentiation.
Assess customer needs and generate sales leads through more personalized service.
Monitor customer satisfaction and recommend approaches to better serve our customers.
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Requirements: |
At the minimum B.Sc. in life sciences (higher degree preferred). MBA an advantage
At least 2 years of experience in 3 or more of the following: product marketing, business development, marcom, B2B sales, capital equipment sales, account management, customer relations, digital marketing, distributor management.
Native English Speaker with demonstrated US business culture experience – a MUST!
Self-starter with a “can-do” attitude – a MUST!
Internet proficiency, Social Media savvy.
Team player with excellent communication skills.
Can handle multiple tasks and projects at a time, agile and responsive.
Work hours and work week are compliant to the US time zone, Monday - Friday.
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Scientific Technical Editor |
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Category: |
Chemistry, Life Sciences, Clinical Research, áéåìåâéä
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Education: |
Masters |
Position type: |
Full Time |
Experience: |
No experiece |
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Area(s) of expertise desired: |
Academic, Biochemistry, Biology, Biophysics, Cell Biology, Cell Culture, Clinical Data Management, Clinical Research, Genetics, Genomics, Microbiology, Molecular Biology, Molecular Modeling, Physics, Physiology, Radiology, Research, Technical Services
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Description: |
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Technical editing of seminar style presentations, written and narrated by world leading experts, in order to transform presentations from a raw-material stage to fully interactive professional talks. The job calls for a full-time position in an English speaking company located in Hertzelia-Pituach and involves a computerised environment.
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Requirements: |
- MSc in life sciences / Biomedical
- English at mother tongue level
- Experience with using/searching internet search engines and academic databases
- Experience with MS Office (experience with PowerPoint - advantage)
- Self-motivated individual
- meticulous/sensitive to small details
- Ability to perform precision work
- Ambitious, hard working and Initiative
Job calls for a full time position, Start time: immediate.
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clinical Operations Coordinator |
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Category: |
Clinical Research
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Education: |
Masters |
Position type: |
Full Time Employee |
Experience: |
2 years |
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Area(s) of expertise desired: |
Academic, Clinical Data Management, Clinical Research, Other, Research
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Description: |
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Requirements: |
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