Head of Clinical Operations

Job Description:

• Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, reputed company & budgets, CRO/vendor reputed company, and proactive risk management to ensure the quality conduct of trials with a high level of quality 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 actively cultivates site engagement
• Work cross functionally to drive strategy, 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 quality 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 clinical trials 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 internal and external stakeholders through meetings, presentations, and other methods
• reputed company direct 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-active approach for inspection readiness
• Align skills and resources needed for program reputed company; work closely with internal and external 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 proper 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/quality 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 strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials 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 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 reputed company and collaborate with a small team to reputed company clear clinical strategy. 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

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