Director of Clinical Operations - Phase I experience preferred
MaxisIT Austin, TX
- Expired: over a month ago. Applications are no longer accepted.
Establishes, implements and assesses department goal achievement while managing the day-to-day activities of the clinical and technical operations staff in the Phase I clinic. Responsible for logistical, operational and strategic planning for all projects being conducted in the Phase I unit.
· Plans for the appropriate study conduct and staffing logistics to ensure a successful weekly Phase I workflow (including volunteer recruitment, clinical conduction, and client deliverables). Assures appropriate and adequate staffing of the clinical and technical operation units.
· Attends regular standing meetings and key sponsor initiation meetings. Schedules operational and study meetings as needed. Communicates with client representatives on a regular basis to gain feedback.
· Participates in meetings with senior management to provide updates, receive feedback, discuss strategic business plans, etc. Initiates and participates in weekly meetings with each department manager and supervisor detailing the workload ahead and determining future needs.
· Regularly participates in weekend coverage as it relates to management oversight of the phase I clinic and is available for client dinners and entertainment opportunities as needed.
· Travels to client companies for business development opportunities. Participates and represents company in 1-2 industry conferences per year for the purpose of solidifying client relationships and bringing in new business.
· Interacts with Business Development for scheduling purposes and to drive business into the unit.
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience. Strong background in project management, regulatory, FDA, and ICH guidelines
5+ years of management responsibility
Strong leadership skills
Knowledge, Skills and Abilities:
Extensive knowledge of clinical trials
Ability to drive and adjust departmental day to day activities to effectively conduct clinical trials
Excellent verbal and written communication skills
Attention to detail and ability to multitask
Knowledge of Microsoft Office software
Strong leadership skills and critical thinking skills
Excellent organizational skills
Effective time management and project management skills
Ability to lead and facilitate cross functional teams successfully
Ability to act as a liaison with the client, investigator, study team and other departments
MaxisIT® is the Clinical Software Organization & only Integrated Software Platform for Biopharmaceutical industry.
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