For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Clinical Project Director has the responsibility of the oversight, planning, initiation, and execution of Clinical Operations programs/ studies as assigned.
Essential Functions
Provides leadership, direction and management to clinical operations and cross functional teams for assigned studies
Oversees the quality related to activities to ensure client deliverables
are met
Serves as primary point for clinical project management and monitoring strategy and overall project alignment both internally and externally for assigned studies
May liaise with other departments or business units to optimize resources as well as to harmonize clinical operations practices, processes, and tools
Contribute operational initiatives and continuous improvement
Uses, metrics, dashboards, and reports to analyze compliance and quality of services to ensure clinical operations and cross functional delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures
Participates and leads in the financial review of project status and drives financial performance, particularly as related to clinical operations
Guides internal teams and sponsors through and documents the key decisions needed to implement a high-quality project delivery. This includes close interaction with project management, data management, quality assurance, biostatistics, medical monitoring, and any other cross functional teams internally and externally as aligned to the assigned study
Oversees the identification of critical data and process, the assessment of risks to protocol execution and clinical delivery, risk and issue tracking and risk and issue mitigation strategies
Provides operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others
Functions as point of escalation for internal and external teams as per the study assignment. This includes, but is not limited to, cross functional teams, client, and vendors
Oversees progress of teams supporting clinical projects
As assigned, may participate in the work streams to support the development and implementation of new initiatives and strategic direction of the Clinical Operations department and cross-functionally
Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP
Ensures individual and team tasks are completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract
Develops and supports customer relationships, manage customer expectations, and escalates more serious risks and issues as required
Identifies needs and may make recommendations for process improvement and efficiencies
As assigned, may provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. This may include client presentations and contributions to the proposal development
Reviews workload, utilization, productivity, and quality for staff on the assigned study
As required, may participate in audits of clinical trial delivery and the audit follow up
Necessary Skills & Abilities
Ability to understand, explain and communicate project concepts and put into detailed plans
Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, encourage, and motivate
Excellent verbal, written, presentation and communication skills are desired
Knowledge of FDA and/or applicable regional regulations, ICH GCP Guidelines, and any other applicable regulatory requirements that govern conduct of clinical trials
Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials
Experience managing and/or mentoring junior staff
Extensive industry experience preferred with direct clinical project management experience or equivalent.
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