Title: Clinical Trial Manager
The Clinical Trial Manager in collaboration with the Clinical Project Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. The CTMs overall responsibility is managing the daily study activities to ensure study team members understand the project deliverables and are adhering to timelines and budget. The CTM is fully accountable for the performance of the monitoring team in all aspects of the delivery such as patient recruitment, quality of the clinical data and compliance with SOPs and GCP.
- Key support role to the Project Manager; manages components of clinical trials and, with minimal direction and oversight, ensures that they are executed to specified quality standards
- In addition to responsibilities related to quality control, provides project management support on budget and timelines, vendor oversight and site management
- Applies knowledge of Promedior Clinical Operations, the scientific/medical objectives of the clinical trials and best practices to assess and evaluate specific components of clinical studies against time, budget and quality parameters
- Provides GCP expertise and brings to bear best practices in areas of oversight, including: monitoring, TMF content, clinical trial supply, and sample collection
- Contributes to TMF QC plan development and performs QC of Trial Master Files; creates, maintains, and closes out TMFs
- Thoroughly understands clinical trial protocols and site specifications and manages the oversight of the data delivery process in clinical trials ensuring consistency with protocols, including participation in data review/ reconciliation efforts
- Manages elements of the quality plan (e.g., inspection readiness, compliance); diligently follows Promedior Clinical Operations SOPs; identifies gaps, and works with other senior Clinical Operations staff or independently to eliminate those gaps
- Ensures patient enrollment activities are within protocol guidelines
- Manages aspects of the relationship with CROs and/or trial sites; works with CPM or other Clinical Operations senior staff to resolve issues or problems with the sites
- Supports the PM in the set-up, conduct, and close out of TMF activities - e.g. Central Lab and ancillary vendors
- Conducts oversight of sample definition, collection, and analysis at the study level and ensures the link back to the program level sample (biomarker, PD) strategy
- Provides study level information to enable accurate and efficient supply of clinical product to the sites and identifies potential risks/challenges associated with doing so
- With minimal oversight from CPM, oversees vendor site monitoring and monitor performance including, monitoring plan creation, oversight of activities at the study level, and ensuring adherence to plan and quality metrics; works with Project Manager with larger vendors/more complex studies
- Actively participates in the development of department initiatives, may act as lead on the development/definition of certain SOPs and processes under the leadership of more senior Clinical Operations staff; provides suggestions on department initiatives and goals that will support and enhance the vision and mission of Clinical Operations
- Reviews and provides input to clinical protocols for feasibility of clinical trials delivery; looks for short and long-term potential obstacles or opportunities for accelerating delivery of a clinical study
- Drafts and manages clinical trial project timelines for elements on a day to day basis, proactively alerting PM and/or senior Clinical Operations staff to risks / challenges
- Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs or delegate; makes sure that completed documents are handed over to RA within the requested; timeframes and ahead of submission deadlines
- With minimal guidance and direction from the Project Manager and/or Clinical Operations management, interfaces with other Promedior functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process
- Ensures patient enrollment activities are conducted in a timely manner
- Provides study level information to ensure timely database lock can occur
Knowledge & Skills
- Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g. Microsoft Project, Word, Excel) and Promedior systems and programs.
- Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Learns, interprets, and explains protocol requirements to others.
- Manages components of clinical trials independently with limited general guidance from senior staff.
- Demonstrates deep understanding of interdependencies of data, technology, vendor systems and metrics and differences across vendor abilities and requirements.
- Strong verbal, written and presentation skills.