Clinical Program Manager
The Clinical Program Manager is a proven Clinical Operations leader, and is accountable for the execution of multi-center, global clinical studies or a suite of studies to required quality standards, ensuring the integrity of the clinical data on schedule and within budget for phase I-IV clinical trials by supervising outside vendors and contractors.
- Responsible for overall operational execution of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.)
- Expert manager of all aspects of a clinical trial from start-up through completion, including experience with writing protocols, informed consent documents and contributing to clinical sections of Investigator Brochures
- Manage the implementation, on-time execution and conduct of clinical studies; driving milestones and timelines within a study budget. All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
- Experience developing and forecasting large study, and program-level molecule budgets, and critically reviewing, negotiating and finalizing vendor budgets and scope change proposals
- Leadership of cross-functional study teams (biostats, clinical pharmacology, data management, medical monitors) to ensure initiation and execution of the clinical study deliverables within approved budget and timelines
- Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
- Responsible for vendor identification/qualification/selection and oversight with proven track record of successful execution and study completion activities
- Lead role in systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
- Deep understanding of how to review, oversee and deliver the trial endgame, which is the data and statistical analyses by critically assessing data to detect trends and outliers to efficiently direct resources and attention to correct problems early
- Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
- Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
- Awareness of disease/ treatment landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
- Desire and ability to innovate in the field of Clinical Operations and to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
- Mentors more junior Clinical Operations team members and may serve as a line manager in some cases
- Demonstrated experience in core and technical aspects of initiating and managing phase 1-4 clinical trials
- Demonstrated experience in management of CROs and vendor selection
- Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
- Possessing excellent interpersonal and communication skills and able to adapt communication style to various audiences
- Success working in a matrix environment
- Demonstrated experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)
- Broad experience in data collection, monitoring, cleaning and analysis throughout clinical development (Phase 1-4)
- Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies
- Multi-task in a fast paced environment
- Build strong cooperative relationships with internal and external stakeholders (e.g. Key Opinion Leaders, clinicians, coworkers)
- Write complex documentation without direct supervision
- Possess a high degree of attention to detail
- Bachelor’s Degree, Master’s Degree or higher in science, nursing, medical field, or business management. An Associate’s Degree/RN or equivalent with relevant years of experience is acceptable.
- A minimum of 12 years relevant experience
- Superior written and spoken communication skills in English
- Ability to clearly communicate complex issues, observations and resolutions to managemen
- Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
- Work on complex problems where the analysis of situations or data requires in-depth evaluation
- Work without close supervision both independently and as part of a team
- Proactively foresee and solve problems and commit to a high level of service
- Propose solutions and schedule all problem solving activities under indirect supervision with defined goals, decisions, and endpoints
Principia Biopharma, Inc. is an equal opportunity employer.