Associate Director Clinical Operations (1025)
ImmaticsAbout the role
FLSA Classification: Exempt/Salary
Schedule: 8:00 am – 5:00 pm; Monday - Friday
Department: Clinical Operations
Reports to: Head of Clinical Operations
Supervisory responsibilities: Yes
Location: Fully Remote
Position Summary/objective:
Global Clinical Trial Oversight.
Essential functions:
Main responsibilities of this position will include but are not limited to the following tasks:
Provide oversight on feasibility analysis, clinical trial site selection, qualification and initiation of new clinical trial sites and contracting with clinical trial sites in USA
Provides clinical monitoring strategy and oversight in USA
Maintains expert-level current knowledge of GCP industry trends and “current-thinking”
Resource planning and onboarding for internal Clinical Research Associates, Clinical Trial Manager and Site Operations Leads in USA
Ensure appropriate line management and employee development for internal Clinical Research Associates, Clinical Trial Managers and Site Operations Leads in USA
Provides oversight on all Immatics clinical trial site related activities, incl. clinical monitoring activities and site operations in USA
Provides oversight of clinical trial site feasibility/selection in USA
Provides oversight of qualification and initiation of new clinical trial sites in USA
Ensures quality and adherence to relevant Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with guidelines and ICH GCP.
Competencies:
Elevated level of individual responsibility & enthusiasm
Work environment:
This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.
Physical demands:
Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
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