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Director, Start-up
hace 1 mes
The Director, Start-Up is responsible for providing leadership and oversight to site contracting, and site activation teams, ensuring alignment with study and site activation timelines. The Director, Start-Up will provide leadership to functional leads of Site Selection and Site Contracting.
The Director, Start Up has line management responsibility for functional area staff in accordance with company policies and applicable regulations. Responsibilities include overseeing the training of the new employees, participating in hiring activities, performance management, guiding professional development, addressing employee relation issues and escalating issues, as necessary.
More specifically, the Director, Site Start up:
- Provides overall guidance and oversight to the department on best practices and guidance for efficient site selection and activation, start up, and site contracting.
- Ensures teams have support and resources to perform efficiently in start up roles in adherence to project timelines and financial goals.
- Manages departmental expenses to be within the approved annual budget. Participates in forecasting expenses and resources needs as required.
- Drives department deliverables and sets priorities for functional teams in site selection and site contracting.
- Identifies processes that need development and improvement. Acts as an agent of change within the organization.
- Develops partnership with targeted sites to establish repeatable accelerated start up strategies.
- Participates in proposal requests by providing recommendations on number of sites and recruitment period for new proposal requests.
- Participates in proposal defense meetings and client interactions, as necessary.
- Supervises the maintenance and development of the investigators database to support site identification and selection.
- Acts as a point of escalation for clients and project teams encountering service delivery challenges during start up. Sets direction with team member to resolve service delivery challenges to avoid missing deliverables. Escalates to senior management significant issues as necessary.
- Ensures adequate training and consistent use by internal team members of SOPs and Tools related to sites selection, site contracting, and site start-up activities.
- Oversees and supports teams to meet project budgets and timelines for feasibility, sites selection, sites budget and contract, ethics submissions, essential regulatory document collection, review and management.
- Develops and maintains positive and productive relationships with key clinical research sites, vendors and sponsors.
- Supports integration of feasibility data and site activation metrics in recruitment projections for proposals and awarded studies.
- Identifies, maintains and reports on key performance indicators (KPIs) for Site Selection, Site Contracting and Site Activation.
- Collaborates with Clinical Operations and Project Management when site quality issues are identified to ensure that impacts on site desirability for inclusion in future studies is related to sites performance through project meetings, escalation of site communications, and quality assurance audit findings.
- Identifies improvements and efficiencies to site selection and activation processes and shares lessons learned broadly with key stakeholders
- Collaborates with Senior Executives to establishes a strategic vision and long-range plan for the department across functional areas.
- Develops new and leads the improvement of existing department systems, SOPs, and processes. Authors, reviews and updates related SOPs and Tools as necessary.
- Ensures consistency and best practices are followed on all processes, protocols, and clinical systems, such as within the Clinical Trial Management System (CTMS) and electronic Trial Master File Ensures proper training is implemented to demonstrate CFR, GCP/ICH compliance
- May perform other tasks in order to fulfill project requirements, as needed.
**Requirements**:
**IDEAL PROFILE**
**Education**
- B.Sc. in a relevant field of study.
**Experience**
- Bilingual (English and French) with excellent written French and English skills.
- Minimum of 10 years’ experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in staff management and in site selection and study start-up activities and/or has worked closely with sites.
**Knowledge and skills**
- Excellent presentation, negotiation, documentation, and leadership skills, as well as strong team-orientation and interpersonal skills.
- Customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations.
- Excellent knowledge of Microsoft Office suite (Word, Excel, Power Point).
- Experience of dermatological clinical research is a definite asset.
- Quick learner, good adaptability and versatile.
- Ability to work in a team environment and establish good relat
