Title: Clinical Project Manager
The Clinical Project Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. They are the primary operational contact for the study and lead the cross-functional global team for execution of the study. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. They should have the command of the projects, the ability to zoom in and out as the situation demands. The Clinical Project Manager should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand implications of decisions that affect study outcomes and timelines.
- Leads several clinical studies under a distinct program and is seen as the standard for project management at Promedior by demonstrating a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities as well as increased strategic insight, decisiveness and strong judgment
- Works to ensure that the standardized approach to project management established by Clinical Operations is adhered to
- Manages clinical trials projects through leadership of and delegation to a cross-functional study execution team, working under the guidance and direction of a Program Lead. May be required from time to time to serve as a coach and mentor to Clinical Trial Managers and junior staff
- Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters
- As a result of a strong understanding of methodologies and approaches, ensures alignment of clinical project goals with Clinical Operations program objectives
- Develops a quality control plan for trial master files and then ensures those TMFs are created, maintained, monitored, and closed out on a timely basis
- Actively participates in the development of department initiatives, including acting as lead on the development/definition of certain SOPs and processes; makes recommendations on how best to approach, manage and engage others on department initiatives
- Ensures site monitoring reports are accurate and thorough and that metrics are being adhered to
- Ensures that an overarching trial cross-functional quality plan is in place and adhered to
- Develops project management skills in self to increase consistency and drive Clinical Operations performance
- Responsible for managing creation, maintenance and close out of TMF activities
- Develops and seeks ways to improve project management processes and SOPs
- Oversees and manages vendors (CRO) to ensure that Promedior's clinical trials are getting the necessary resources and attention the vendor has committed to ensure trial deliverables and performance goals are met.
- Develops project management skills in self and others to increase consistency and drive Clinical Operations performance; mentors CPM, and CTM staff as appropriate
- Manages ancillary vendors, including IVRS, central lab imaging vendor, central ECG, central pathology selection, set-up, conduct, and close-out
- Oversees the development of and adherence to clinical trial project timelines and ensures senior Clinical Development staff informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
- Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, and data collection) with other Promedior functions to support clinical trials delivery within the drug development process
- Ensures that all clinical data, including third party data, is managed and completed in a timely manner in order to enable Data Management to lock the database on appointed dates
- Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget;
- Oversees the administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
- Adheres to clinical trial budgeting process and provides input on process optimization
- Leads matrix, multi-disciplinary, cross-functional study execution teams from start-up through close to ensure both internal and external deliverables are on time and on budget
- Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive landscape
- Leads cross functional team to ensure timely activation of clinical trials; including risk management, problem-solving;
- Proactively identifies, negotiates and brokers solutions to individual clinical study issues
- Delegates and oversees the management of certain aspects of project management to CTM staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters
- Proactively identifies, negotiates and brokers solutions to cross-study issues and identifies connections with other studies
Knowledge & Skills
- Demonstrates ability to provide input into clinical protocol development.
- Demonstrates extensive experience and expertise in managing high-volume/complex clinical studies.
- Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Proactively and independently manages vendors, including identification and mitigation of risk.
- As a result of being member and project manager of clinical study execution team, develops detailed understanding of different departments and functions within Promedior and interdependencies of the functions.
- Very strong verbal, written and presentation skills are required.
- Experience in leading of a matrixed cross-functional team.