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Responsibilities
The Clinical Trial Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The Clinical Trial Manager (CTM) leads and directs cross functional teams and understands/manages client expectations. In addition, the Clinical Trial Manager (CTM) proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted accountabilities may or
may not apply.
Daily Management of a Trials POC for sponsor, sites and CRAs
Study Tracking and Monitoring trip report review
Provides Project Oversight and Leadership for Clinical Deliverables:
Leads and manages the start-up and clinical teams Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates. Works with the team to set priorities Takes the initiative to make things happen and leads and supports the relevant staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters Motivates the clinical team Ensures effective communication plans are place for the clinical team Ensures effective escalation plans are in place for the clinical team Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.
Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.
Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
Project Finance
Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).
Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget Ensures that forecasted units are achieved as planned and within the budgeted FTE Identifies out-of-scope tasks from clinical team and escalates as required Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval by the relevant PRA staff.
Customer Relations (Internal & External) Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas, escalating as required Participates in client meetings, assisting with presentations as required Contributes to Business Development activities
Qualifications
Education:
Bachelors Degree in health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
Experince requried:
2+ years of clinical research project management experience required
