Senior Clinical Trial Manager

The Senior CTM role sits within the Clinical Operations Department at Definium Therapeutics and provides site and/or country level management as well as vendor/external service provider oversight and management.  As a Senior CTM, this role may be assigned as the Clinical Operational Trial Lead on a clinical trial, with oversight by the Senior Director/Executive Director of Clinical Operations within the organization. The role provides operational oversight at the site level and/or country level (for larger late phase trials) and is responsible for oversight and management of external service providers/vendors, ensuring high-quality deliverables, within agreed upon timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The Senior CTM, if assigned as the Clinical Operations Trial Lead for a trial, is responsible and accountable for ensuring successful cross-functional delivery of the trial, with scope from draft protocol synopsis to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results. The Senior CTM, whether managing site/country and vendors or as the Clinical Operational Trial Lead, will ensure ongoing inspection readiness, data integrity and overall data quality according to and in compliance with corporate and project/program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations.

The Senior CTM role will assist in the development and review of Clinical Operations Department SOPs, Plans and Systems build.  In addition, will lead process improvement initiates, create processes not currently in place, including the creation of site/trial management tools.  For outsourced trials to a CRO, this role will serve as a key liaison with oversight and delivery of the transferred obligations and responsibilities.

Responsibilities: 

• Utilize Definium’s or CRO systems (when outsourced) to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality
• Serve as Sponsor contact for external service providers/vendors with overall responsibility ensuring deliverables are executed with high quality and within timelines and budget
• Oversees and tracks CRO/Vendor partners to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed
• Maintain therapeutic knowledge and familiarity with clinical protocol(s) and project(s) as appropriate
• Work with CRO/Vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
• Oversight of CRO monitoring team activities and deliverables
• Assist QA with site audits
• Review and contribute to study protocols, changes in eCRF design, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study-related documents/plans
• Perform financial management, including review and approval of site contracts and budgets, as well as CRO/Vendor invoices and accruals with oversight by the Senior Director of Clinical Operations
• Assist in tracking and coordination of trial related materials, including investigational product, clinical trial and laboratory samples, etc.
• Organize and manage site round-table meetings and site recruitment meetings
• Participate in the development, review and implementation of departmental SOPs, systems and processes
• Provides oversight of external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines
• Ensures that the trial team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial utilizing the available tools
• Ensures trial team members have received the appropriate trial-specific training needed for their function; in collaboration with the study clinician, ensures appropriate trial-specific training is given to trial team members and/or to the CRO

REQUIREMENTS: 

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO
• Experience with managing clinical trials or prior experience in a senior CRA role, ideally in the psychiatric space
• Willingness and ability to travel up to 20% of the time, defined by business needs
• This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment
• Requires clinical research operational knowledge, project planning/management, communication, and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing teams in a virtual environment is required.
• Experience in vendor management strongly preferred
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness