At Clexio, we view our team as one of the key components to our success. We are always looking to add to our talented and creative team of professionals.
Below are the positions currently available at Clexio:
Phase 1 lead
#43Location: Petach Tikva, Israel
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Responsibilities
Design of the phase 1 study (synopsis) to support project development
Support CRO selection process for Phase-I studies
Lead and manage the study planning activities
Be a point of contact between the CRO and Clexio team
Lead the review and finalization of study-related documents (Protocol, ICF, CRF, etc.)
Manage communication and overall execution of the study according to the study plan until completion, in line with regulatory requirements and internal guidance
Manage CRO and any external service providers that are involved in the phase 1 study
Together with the CRO and Clexio’s project team, ensure that the study is in accordance with predetermined/set timelines & budget
Thorough review of the study data (review data listings, eligibility of subjects, safety results, etc.)
Upon study closure: leading the review of Clinical Study Report (CSR)
Requirements
PhD/MSc in pharmaceutical/life sciences, PharmD, MD or any other relevant education
Significant experience in drug development /clinical pharmacology/Phase 1 studies
English proficiency with strong presentation and communication skills.
Ability to work in a complex multi-disciplinary and global environment.
Hands on experience in non-compartmental, population, PK/PD analysis – an advantage
Manage and oversee the operational aspects of global clinical trials
Responsible for the successful execution of global clinical trials from the protocol through the clinical study report, ensuring completion of study deliverables and adherence to budget
Responsible for the CRO selection process and management of the CRO and other third party vendors on assigned study
Regularly interact with the clinical sites to ensure engagement, good study progress and quality of the data
Responsible for timely recruitment and overall study timelines
Qualifications
Nursing or life science degree
At least 5 years of experience as CTM or project manager from Pharma, CRO or Biotech with successful records in conducting global late stage clinical trials experience in Psychiatry trials is an advantage
Strong operational management with attention to detail
Strong knowledge of GCP/ICH guidelines
Excellent communication skills in English (oral and written)
