Senior Clinical Project Manager

The Senior Clinical Project Manager position is responsible for overseeing and conducting clinical research trials. They will ensure that clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials meets the requirements for Regulatory Authority approval. This position provides strategic and tactical operational planning and execution of all phases of clinical programs.

• Plans and manages assigned studies from start to close out while managing project timelines and project budget.
• Proactively anticipates and understands concerns/issues/delays in the project and develops risk assessment and contingency plans. Holds each functional area responsible for associated risk mitigation and management.
• Primary source of communication for the clinical project team as well as the cross functional project teams both internal and external stakeholders.
• Participates in project kick-off meetings, provides regular updates to client, and ensures maintenance of communication between team members and client.
• Monitors project budget vs. cost. Responsible for timely execution of change orders to ensure that the project margins are being met.
• Tracks and forecasts budget, metrics, timelines progress for all project deliverables to enable better project decisions.
• Gathers metrics from cross-functional areas in relation to project progress.
• Provide study-specific training for the assigned clinical operations staff as appropriate.
• Evaluate and identify resourcing needs and continuously monitor the life cycle of the study.
• Develop, analyze, and report study metrics to Sponsor per Project Plan and proactively identify and communicate any risks or concerns.
• Develop and maintain Study Project Plans including, but not limited to, site selection and monitoring plans, TMF management plan, payment plans, etc. Also responsible for creating, training, and updating study specific tools and templates to be used throughout the course of the trial.
• Provide strategic input into study documents such as study synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Safety Plan, Clinical Database edit specifications, Annotated Monitoring Visit Report templates, Clinical Study Report development, etc. as assigned.
• Manages study drug product and non-drug site supplies (study materials/equipment/manuals), deliverable development, shipment, tracking accountability and resupply to sites as needed.
• Develops the agenda and manages the planning and execution of Investigator Meetings: meeting vendor contracting and management, coordinate development of meeting agenda, content development and delivery of operational (non-Clinical Science) presentations and training materials, manage meeting execution and documentation; ensure input from key stakeholders.
• Responsible for the development and presentation of slides and training materials for various audiences.
• Assists with vendor selection (ECG, Lab, IWRS, IRB, Raters) and contracting for assigned studies.
• Ensures clinical study team compliance with applicable FDA / ex-US regulations, ICH-GCPs, other local regulatory requirements and corporate SOPs.
• Develop subject recruitment/retention strategy and related initiatives for assigned studies.
• Collaborate and communicate with other functional areas to identify and evaluate fundamental issues on study related projects.
• Leads and/or participates in investigator, client, and cross-functional team meetings.
• Oversee maintenance and quality review of study TMF.
• Develop and maintain tools for management of study deliverables (i.e., timelines, study plans, adherence to monitoring plan and TMF plan, etc.).

Qualifications

• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with e-mail and calendar programs. Experience with IVRS and EDC systems a must.
• Knowledge of FDA and/or Regional Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Bachelor's degree or advanced degree (e.g., Master, PharmD, PhD) preferred. Candidates with equivalent combination of education, training, and experience will be considered.
• At least 7 years of clinical trial experience.
• Experience managing/mentoring and developing junior staff.
• Demonstrated experience in change management initiatives.