PSI CRO
Biotech
ClinicalOperationsManager/Lead
Neural analysis suggests this role is
optimal for director candidates.
“Clinical Operations Manager / Lead at PSI CRO. Skills: Clinical operations, Team supervision, Process management. Support line management. Manage clinical operations staff”
Industry & Context.
Ability to travel internationally
What They're Looking For.
Must Have
College or University degree, Operations experience in CRO, Experience with clinical research sites, Experience with study logistics, Experience with legal in Israel, Experience with regulatory in Israel, Experience with ethics in Israel, 2 years experience in clinical team supervision, Experience with remote team staff, Excellent English, Excellent Hebrew, Ability to travel internationally
Nice to Have
Operations experience in pharma company, Experience in all study phases in Israel
What You'll Do.
Support line management
Manage clinical operations staff
Manage multiple aspects of clinical research
Coordinate resource allocation
Monitor resource utilization
Oversee staff workload
Support performance appraisal
Support career development
Train clinical operations team
Coach clinical operations team
Mentor clinical operations team
Onboard new employees
Integrate new employees
Ensure GCP compliance
Ensure internal procedure compliance
Ensure external procedure compliance
Develop quality control
Implement quality control
Oversee regional projects
Maintain regional processes
Revise regional processes
Establish regional processes
Ensure smooth operation
Communicate with investigators
Communicate with regulatory authorities
Communicate with ethics authorities
Communicate with clients
Communicate with vendors
How You'll Work.
Team & Collaboration
Cross-functional coordination; Vendor management; Stakeholder management
Communication Scope
Presentation skills
Process & Methodology
Study startup, Study close out
Full Job Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Office-Based in Ra'anana, Israel We're on the lookout for a knowledgeable, proactive and dedicated person to support and develop our Clinical Operations team in Israel. The scope of responsibilities will include: * Support line management of Clinical Operations staff * Management of multiple aspects of clinical research from business development to project execution * Coordination of resource allocation to projects and utilization monitoring * Oversight of the staff workload, support performance appraisal and career development * Training, coaching and mentoring the team * Involved in hiring, onboarding and integrating of new Clinical Operations’ employees * Ensuring compliance with GCP standards and internal/external procedures * Development and implementation of quality control * Regional project oversight * Maintenance, revision and establishment of processes on the regional level * Ensuring smooth operation from Study Startup to Study Close out stages * Communication point to investigators, regulatory and ethics authorities, clients and vendors for various project-related matters ## Qualifications * College or University degree in Life Sciences * Demonstrated operations experience in a CRO (preferable), or a pharma company * Experience with clinical research sites, study logistics, legal, regulatory and ethics in Israel * Experience in all study phases in Israel (preferable) * At least 2 years’ experience in clinical team supervision including Remote team staff * Excellent English and Hebrew * Ability to travel internationally * Strong time management, organizational, leadership, planning and presentation skills, result-oriented approach ## Additional Information We offer: * Excellent worki
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