Skip to Main Content

Director of Clinical Operations - Phase I experience preferred

MaxisIT Austin, TX

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Summarized Purpose:

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.

Essential Functions:

·         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


Company Description
MaxisIT® is the Clinical Software Organization & only Integrated Software Platform for Biopharmaceutical industry.


MaxisIT® is the Clinical Software Organization & only Integrated Software Platform for Biopharmaceutical industry.

MaxisIT's Logo


Austin, TX



View all jobs at MaxisIT