Clinical Operation Director
Reports to: Chief Executive Officer
1.Perform overall management for clinical operation to ensure timely delivery, data quality and budget within control
2.Work with CRO and internal cross-functional team to drive the development of effective and innovative clinical trial designs and facilitate the execution of clinical trials
3.Build up and manage Zion’s clinical operation team
1.Ensure management of trials are done in compliance with ICH, GCP, local laws and regulations
2.Provide country specific guidance and oversight to CROs where needed
3.Develop and maintain KOL relationships
4.Ensure clinical trials are effectively executed and completed within budget, timelines and meeting enrollment commitments as well as routine updating of CTMS and other clinical systems. Pro-active trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties.
5.Manage site pre-selection and validation process. Support local investigator meetings, ensure contracts and applicable reg documentation is obtained prior to study start. Facilitation of all aspects of IRB/ERC and Regulatory Agency submissions. PPOC for all logistical and operational issues and facilitate general communication.
6.Oversee drug and clinical supplies management to ensure sites have timely availability of required materials to avoid disruption of protocol deliverables and to oversee appropriate final disposition of IMP.
7.Ensure clinical study site close-out in accordance with local regulations and ensure dissemination of clinical trial results to the participating study investigators. Oversee appropriate file archiving of all relevant study materials in accordance with local law and guidelines.
8.As Clinical Operation expert to provide inputs into protocols, manuscripts/publications, IBs, regulatory and study reports
1.Bachelor’s degree in disciplines associated with medical sciences. Advanced degrees would be a plus
2.At least 2-3 years’ clinical project management experience and at least 6 years clinical research experience from within the pharmaceutical industry or similar organization. MNC background is preferred
3.Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
4.Thorough understanding of the drug development process
5.Comprehensive understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
6.Comprehensive understanding of both site monitoring and study site management requirements
7.Comprehensive understanding of applicable regional regulatory requirements
8.Ability to work with minimal supervision
9.Good planning and organization skills
10.Ability to lead and develop junior staff
11.Ability to understand and work with financial information
12.Ability to resolve project-related problems and prioritizes workload for self and team
13.Ability to lead a project team
14.Ability to work efficiently and effectively in a matrix environment
15.Good computer skills with good working knowledge of a range of computer packages
16.Excellent verbal and written communication skills
17.Excellent English language skills