Clinical affairs Team Leader
About The Position
ElMindA, a leading company in the brain health technologies is looking for an experienced and passionate Clinical affairs team leader. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the company’s vision and strategy.
The Clinical affairs team leader is responsible for the successful planning, management, oversight and execution of clinical trials. The span of activities is broad covering clinical activities in study start-up, initiation and will include project management, execution, strategic planning, team building and team training while working locally and globally. You will be involved in the daily operations of clinical programs. You must have an expert and comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards. Under the direction of the Director of Clinical affairs and VP of Clinical and Regulatory affairs, is responsible for successful execution of clinical trials according to regulatory guidelines. You must facilitate effective internal and external relationships. S/he is responsible for achievement of project goals and objectives on time and on budget.
Primary Roles & Responsibilities
You will be involved in most Clinical activities:
- Manage clinical studies and the process to identify and solve operational issues and drive delivery to plan through internal and external partners
- Responsible for project management and execution, including the development, initiation, conduct and maintenance of realistic, up to date and appropriate quality, project and study plans (including timelines and budgets) in agreed systems
- Oversee clinical trial conduct and monitor work performed internally and externally to ensure delivery against contract, according to budget and in accordance with corporate timelines.
- Prepare, review and manage clinical research budgets, timelines and performance metrics
- Prepare the design, format and content and/or provide technical expertise for the development of essential clinical documents (e.g., protocols, CRFs, ICFs, SOPs, monitoring plans, clinical trials report)
- Track items related to CDAs, contracts, budgets and completion status
- Prepare study feasibility and study specifications
- Maintain frequent contact and work effectively with site investigators and coordinators
- Prioritize study monitoring needs
- Review monitoring reports for accuracy, completeness and conformance with SOPs
Monitor clinical sites for adherence to protocol and GCP, including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits
- Review and resolve discrepancies in clinical data with clinical sites
- Resolve patient eligibility and protocol deviation issues
- Manage the overall accountability and reconciliation process
- Manage Clinical affairs team of 2 CRA's
Scope of Work:
Essential skills & experience:
· Strong communication skills, proven negotiation skills and team player
· Strong understanding of clinical research, study design, biostatistics and medical terminology
· Strong critical and logical thinking with ability to analyze problems, identify alternative solutions and implement recommendations for resolution
· Understands and interprets data/information and its practical application
· Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast paced and demanding environment
· Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
· High level of written and spoken English and Hebrew -a must.
· Availability to travel abroad - 30%
· Availability to work with the US considering the time difference.
· Experience with regulatory clinical submissions in Israel and abroad.
· Proficient in pertinent software and tools
· Must be knowledgeable in industry trends for clinical operation
Desirable Education and experience background:
- Minimum of Bachelor's degree, preferably in medical or biological sciences or discipline associated with clinical research.
- Advanced degree is preferred.
- 6 years of related medical device industry experience and Quality assurance
- GCP and CRA certificate
- 3 years experience as CRA