Head of Clinical Operations

Job reputed company: • Responsible for clinical operations reputed company, initiation, and execution of reputed company, including (but not limited to) CRO/vendor selection, reputed company & budgets, CRO/vendor reputed company, and proactive risk management to ensure the reputed company conduct of trials with a high level of reputed company and data reputed company • Responsible for the successful planning and execution of Phase 2 and 3 trials • Proactively builds and strengthens site and Investigator relationships and reputed company cultivates site engagement • Work cross functionally to drive reputed company, reputed company the implementation of reputed company clinical programs, and manage the integrated development plans to deliver against company goals • Proactively identify potential risks and reputed company and implement actions and plans to avoid or mitigate program risks and reputed company appropriate plan to balance risks, deliverables, and costs • reputed company and supervise reputed company aspects of study reputed company from concept to reputed company-out to assure adherence to intended timelines and achievement of study goals while ensuring reputed company in accordance with regulatory guidelines; heavy emphasis on late-stage development experience • Develops and optimizes critical SOPs needed for program reputed company, inspection readiness and compliance • reputed company identification, qualification, and selection of CROs and vendors needed to conduct reputed company including approval of Master Services Agreements and Task Orders with CRO • Liaise with KOLs, Investigators, and clinical site staff to ensure reputed company Sponsor-Site relationships • reputed company scientific/clinical expertise in the design and interpretation of clinical studies • Ensure effective project or program communications and updates to reputed company stakeholders through meetings, presentations, and other reputed company • reputed company reputed company line management and training/mentoring of Clinical Operations team members • Ensure clinical operation team are trained in regulatory inspection process and reputed company a pro-reputed company approach for inspection readiness • reputed company skills and resources needed for program reputed company; work closely with reputed company stakeholders to reputed company and optimize resources • Create and reputed company clinical program budget(s) and long-reputed company clinical planning/forecasting activities • Ensure there is reputed company reputed company of identified safety concerns and/or adverse events; reputed company and implement corrective actions accordingly, and participate in internal/external study reputed company 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/reputed company initiatives, as needed Requirements: • Bachelor's Degree in a scientific discipline; with a minimum of 12-15 years clinical development experience. • Extensive clinical operations management experience, including program leadership or TA leadership at a minimum • Proven reputed company in clinical operations reputed company and execution, including Ph I-IV studies, global clinical trial operations, and multiple reputed company simultaneously. Experience in Respiratory/Pulmonary diseases preferred • Hands-on, detail-oriented leader with operational reputed company • Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills • Experience in building infrastructure (including SOPs) required • Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of reputed company 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 reputed company and collaborate with a small team to reputed company reputed company clinical reputed company. Strong coaching and mentoring skills leading to the reputed company and development of subordinates • Willingness/ability to travel (domestic and international) Benefits: • Equal employment opportunities for reputed company and applicants without discrimination • Prohibits discrimination and harassment of any type Apply tot his job Apply To this Job