Position Summary
The Head of Clinical Operations will be responsible for the operational management of early phase clinical trial(s), starting with a Phase 1/2a trial for a peanut allergy therapeutic, and for the delivery of operational activities as defined in the trial outline/protocol and clinical development plan, according to the agreed quality, budget and timelines.
The position requires hands on work and routine interaction with key internal and external stakeholders, communicating clinical status, escalating issues, and troubleshooting routine inquiries.
Responsibilities
Lead the operational management of the trial - build its operational strategy and be in charge of study execution
Provide Clinical Operations expertise and leadership in the evaluation, selection, and management of Global Contract Research Organizations (CROs) and other external vendors to ensure successful First in Human clinical trial implementation and execution
Proactively manage CROs and other vendors in all aspects of study progress from planning to close-out
Lead study start-up: Identify potential study sites, site selection and facilitate the development of clinical trial agreements and other relevant documents
Lead the development, approval, execution and maintenance of all study operational plans (i.e. trial risk management plan, communication plan, monitoring plan, data plan, etc.)
Collaborate cross functionally with the program clinical development functions (internal and external stakeholders) to deliver the trial according to plan and in the highest quality standards
Oversee, manage, and ensure clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
Manage and ensure the execution of the logistical plan for the trial (trial materials supply, labeling and packaging, etc.)
Contribute and/or author the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
Contribute to global & local regulatory submissions (FDA, EMA, IMoH and other governing regulatory bodies)
Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships
Provide ongoing clinical trial financial reporting and forecasting
Develop, review and approve Clinical Quality Documents
Willingness to work on the strategy level and also work hands-on
Willingness to work on the strategist level and also work hands-on
Experience
Minimum 10 years clinical trial operations experience in pharmaceutical, CRO, or healthcare industry - required
Bachelor degree in a related scientific field - required; M.Sc. / Ph.D or M.D in relevant disciplines - advantage
Experience with study start-up, timeline planning and management and financial management of clinical trials including vendor oversight - required
Previous experience in management of domestic (Israel) as well as international clinical trials - preferred
Thorough understanding of clinical research principles and process
Strong knowledge of GCP and regulatory requirements
Skills
Excellent organizational and time-management skills
Strong interpersonal skills
Effective verbal and written communication skills including presentation skills, in English and in Hebrew
Team player and able to work independently
Ability to work well under pressure and with tight schedules
Position location: Rehovot, Israel + Overseas travel (as needed)
Apply via: jobs@ukko.us or Apply now