Director Clinical Operations
St. Louis, MO
Job Order: GD-798
- Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations.
- Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic.
- Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results, ensuring that high-quality customer service is offered by all clinic employees.
- Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff.
- Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies.
- Participates in strategies decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
- Maintains current professional knowledge base of clinical research methodologies and regulatory requirements.
- Interacts with Study Monitors, investigators, regulators, vendors and other external to the Company.
- Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
- Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings.
- Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies.
- Performs other tasks and projects as assigned.
- Review of lab data, assisting QC reviewers
- Review lab data generated, ensuring that all documentation is accurate and in accordance with SOPs and regulatory guidance.
- Offer technical leadership during OOS results and assay failures, ensuring investigations are conducted promptly and thoroughly.
- Assist the Laboratory Director in daily lab operations
- Minimum nine years’ experience in clinical research, five years in a management role and at least four years of relevant experience in a CRO environment
- Extensive experience managing Phase I-II b, Bioavailability and Bioequivalence studies
- Degree in Health Sciences or related discipline (MD or RN preferred)
- CCRP certification
- Computer literacy and excellent communications skills
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