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The Clinical Trial Lead is responsible for the operational execution of US Phase IV clinical studies, Investigator Initiated Trials (IITs), and compassionate use programs. Phase IV clinical support includes protocol development, review/reporting quality trial data, and study reporting/publishing in compliance with client processes, GCP/ICH and Regulatory requirements. IIT program support includes review and approval of strategically aligned studies, and management of budget. Independently supports program level activities as assigned. This position is key to maintaining good communication and professional relationships with internal and external clinical trial stakeholders.
• Expected to manage IITs, Phase IV trials, and compassionate use programs as defined by the US organization in-compliance with all external regulatory standards and internal policies, SOPs and standards.
• Provide input to protocol design and operational aspects of the trial. Write protocol and informed consent study documents and study tools.
• Independently develop strategic trial execution plan (e.g. contingency plans) and timeline commitments for the US.
• Oversee local vendor selection and performance. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial ream as required.
• Lead and chair Clinical Trial Team Meetings (CTT), attend and participate in operations meetings.
• Responsible for the initial and subsequent drug supply in collaboration with the Local Drug Supply Manager.
• Coordinates and manages the site selection process in collaboration with the CRO.
• Prepare clinical trial budgets, forecasts and seasonalization as part of strategic plan. Manage IIT study program budgets reporting to Sr. Management and Finance monthly.
• Responsible for execution of assigned clinical deliverables within approved budget for all Medical Units within US CDMA.
• Drive the conduct of the trial, track and oversee progress and status. Ensure all operational aspects are on schedule. Oversee local clinical team activities to achieve trial timelines and quality execution according to client standards regulations.
• Maintain trial master file and ensure collection of all documents, ensure storage and scanning into archive database.
• Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required.
• Responsible for the ongoing review of clinical trial data as outlined in the data handling plan or equivalent.
• Accountable for coordinating data management activities through the CRO driving database lock activities ensure data complete activities.
• Provide input and prepare and coordinate clinical study report and appendices.
• Responsible to keep reporting systems up to date (e.g. lmpact, ClinAdmin, TMF, CREDI) throughout the lifecycle of the trial.
• Ensure that all trial close-out activities arc performed, in close cooperation with field monitors and clinical trial head.
• Facilitate internal audits and HA inspections as required. Assist in audit response and implementation of corrective actions following audits and inspections in relationship with Quality Assurance.
• May be involved with special projects and work streams.
Key Performance Indicators
1. Timely and quality execution of trial related activities (e.g. key milestones, 100% of target enrollment at last patient first treatment, 100% clean data). Effective management of IIT plan development and execution.
2. Timely submission and delivery of high quality clinical trial documentation.
3. Trials are executed on time, budget and in compliance with local regulations and client internal standards.
4. Successful execution of complex projects involving multiple stakeholders
5. Ability to influence effectively in a highly matrixed environment to achieve desired business outcomes
6. Ability to effectively communicate
This position will be filled at a level commensurate with experience.
• Bachelors Degree in scientific or healthcare discipline is preferred, (preference for Sciences), advanced degree desirable
• 5+ years of experience in clinical research management
• Experience in a monitor role or a role overseeing clinical trials desirable
• Experience in managing a project budget required
• Strong Interpersonal skills
• Strong Project Management and Leadership skills
• Ability to work under pressure
• Ability work in a matrix environment
• Displays innovative ideas and solutions
• Highly proficient in negotiation skills
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