- In collaboration with the Sr. Director, Director, TIMI Principal Investigators, and Study Sponsors, establishes, maintains and complies with policies and procedures for assigned department / trial(s).
- Is knowledgeable of all aspects of assigned department / trial(s) to be able to evaluate questions and problems. Triages items to individuals with resources available to solve problems or answer questions.
- Directs internal staff involved in daily tasks performed in the TIMI Study Group to ensure smooth and efficient operations.
Works with Sr. Director / Director in hiring, training, and evaluation of assigned support staff.
- In collaboration with Sr. Director / Director, works directly with external key stakeholders to ensure smooth operations for vendor and study sponsor management.
- In collaboration with Sr. Director / Director by writing memos, educational materials, newsletters, and articles. Creates presentations related to departmental / trial goals, strategies and outcomes.
- In collaboration with Sr. Director / Director in the design of reporting tools to capture necessary information to reach goals of the department / trials.
Assists in re-design of reporting tools as a result of study design change or amendment.
- Designs and updates Manuals of Operation for assigned department / trial(s).
- Participates in internal and external audits. Works with Sr. Director / Director to design, implement, and evaluate departmental quality control activities.
- Identifies, organizes, and ensures accurate completion and retention of required departmental / trial(s) regulatory documents and other relevant files.
- Keeps Sr. Director / Director informed of all issues, solutions and results by monitoring progress of departmental / trial(s) metrics on a regular basis.
Must be able to interpret weekly report statistics, develop and implement action plans to address concerns when necessary.
Participates in conference calls and departmental / trial(s) related meetings, presentations and trainings as requested.
Prepares agenda and minutes. Ensures all supportive documentation is available to participants.
- Monitors expenditures and suggests modifications in expenditures as necessary or as directed by Sr. Director / Director.
- Demonstrate and maintains high level of knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department / trials(s)
- Maintains department service standards, with particular attention to personal / behavioral, staff teamwork, and customer-staff interaction guidelines.
- Performs other tasks and responsibilities as directed.
- Bachelor's degree required
- 6 to 7 years of Industry (domestic / international clinical trials) and / or other relevant experience
- Data mgmt experience
- Supervisory experience
- Clinical Trial Certification
- Trial Budget experience preferred
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