Sr. Clinical Study Manager

KPS Life is seeking a Sr. Clinical Study Manager with CNS experience. This role will be dedicated to one of our Sponsor Partner Programs. Office based in San Diego, CA

Primary Purpose and Function

Clinical Study Manager

The Clinical Trial Manager (CSM) is responsible for study team leadership in one or more cross functional study teams to deliver clinical research study deliverables on time, within budget and with good quality in compliance with Regulatory Authorities’ regulations/ICH GCP guidelines and applicable SOPs. This role collaborates and interacts with the Clinical Study Team and oversees the functional duties of the study and CRA team.

Major Duties and Responsibilities

The CSM Will

• be responsible for the oversight of the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as applicable SOPs and policies.
• be responsible for the oversight of monitoring assigned study operational plan.
• be responsible for managing assigned as study budget, timelines, and risk mitigation
• process input from key stakeholders, communicating to the clinical team, as appropriate.
• support the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
• be responsible for the filings of all clinical trial documentation in eTMF and paper TMF as assigned.

Competencies

The CSM Will Have

• in-depth knowledge of clinical drug development processes and experience applying GCP, ICH and FDA requirements.
• solid knowledge of clinical research study protocol and processes; ability to incorporate and adhere to GCP and regulatory standards. Ability to develop study processes in support of a clinical study design.
• demonstrated solid knowledge in several areas related to clinical research: human anatomy, subject protection, regulatory requirements, study design, study execution.
• demonstrated skills in implementing tools for effective study management, identifying and implementing solutions to address study issues, overcoming obstacles.
• demonstrated skills in cultivating relationships with healthcare professionals and cross-functionally with co-workers from both the Sponsor and KPS teams
• demonstrated skills in maintaining composure and identifying and adapting to shifting priorities and competing demands
• Excellent written and verbal communication.
• The ability to generate concise summaries for different audiences, professional correspondence, presentations, reports, and training materials.
• Literacy in word processing, spreadsheets, and databases applications (e.g., MS Word and Excel).
• Skilled at developing project timelines and milestones and working with team to ensure milestones are met; adjusts appropriately when needed and communicates risks when necessary.
• strong communication skills to be able to discuss with the Principal and Sub-Investigators and their site staff, even in challenging situations such as recruitment, protocol deviations and oversight.
• Ability to identify and articulate risks and benefits of plan.
• High attention to detail and accuracy; ability to ensure data accuracy and review data.

Education And Knowledge Requirements

The CSM will have:

• BS degree in biology, allied health, nursing or related life science preferred.
• 5 or more years related experience in clinical study execution.
• experience leading a study or significant participation on study team through major milestones.
• experience in planning study design for pre and/or post market trials.
• experience managing others as direct supervisor and/or leader of matrix clinical trial team preferred.
• experience managing CROs and other external providers.
• system experience preferred: (i.e. CTMS, eDC, eTMF etc.).

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