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
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
Job Requirements:
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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