Note: The job is a remote job and is open to candidates in USA. The client is an emerging company developing transformative treatments for people with pulmonary disease, primarily pulmonary hypertension. The Senior Project Manager, Clinical Operations will establish clinical program and trial execution strategies, lead Phase II and III trial planning and execution, oversee CROs and vendors, manage risks and budgets, and ensure regulatory compliance and data integrity.
Responsibilities
- Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO selection, contracts & budgets, CRO oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity
- Responsible for the successful planning and execution of Phase 2 and 3 trials
- Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement
- Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
- Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs
- Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience
- Develops and optimizes critical SOPs needed for program success and compliance
- Represent the clinical operations program on strategic governance bodies (e.g., Safety Team, Project Team, etc.)
- Support identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders
- Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
- Provide scientific/clinical expertise in the design and interpretation of clinical studies
- Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
- Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
- Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
- Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities
- Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
- Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
- Participate in business development and process improvement/quality initiatives, as needed
Skills
- Extensive experience with Phase II & III pivotal trails
- Proven excellence in clinical operations strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials simultaneously
- Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy
- Willingness to work across all levels to support Clinical Operations success
- Strong communication and presentation skills
- Experience in Respiratory/Pulmonary diseases preferred
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