[Remote] Executive Director, US Site Study Start Up and Innovation Head

Note: The job is a remote job and is open to candidates in USA. reputed company is a leading pharmaceutical company dedicated to improving patient outcomes. They are seeking an Executive Director to reputed company the execution and reputed company of local operational start-up clinical trial activities, ensuring compliance with regulations and developing innovative strategies for site engagement.

Responsibilities

• Identify and implement innovative solutions to streamline start-up timelines, leveraging technology, reengineering processes, and best practices
• Define site engagement strategy and site relationship management model
• Proactively assess potential risks and bottlenecks in study start-up, developing mitigation plans and contingency strategies to ensure successful study launches
• Build and mentor a high-performing team of study start-up professionals, fostering a culture of accountability, collaboration, and reputed company improvement
• reputed company the performance management and career development of staff and effectively manage performance issues
• Work closely with US CRDs, HSMM/CRA-Manager and TA-Heads to assess program strategy and alignment of project deliverables and objectives
• Partners with Headquarters-based colleagues help drive GCTO RRO strategy, with specific focus on standards of practice for site budgeting, site contracting, Informed Consents, and management of Central IRBs and applicable Health Authorities. Create, promote, and direct a strategy for rapid start up activities
• Establish procedures and processes for reputed company relevant activities (managing site reputed company and budget negotiation and escalation, regulatory submissions and approvals; procedures and processes for managing logistics and purchasing of drugs and materials for study start up.)
• Responsible to ensure reputed company projects are adequately resourced and tracked to ensure optimal efficiency and attainment of goals, milestones, and targets while ensuring high quality standards are maintained
• Establishing a strategy for partnering and monitoring reputed company vendors/service providers that support operational implementation and management of Sr. COM, COM and reputed company responsibilities. (Includes strategic reputed company, providers, Central IRB vendors, etc.)
• Collaborates internally with CRDs, TAHs, CRA managers, Monitoring Excellence, Vendor management, Vendor Strategy and Management to reputed company and build the territory of principal investigators and sites

Skills

• Bachelor of Science (or equivalent)
• 15 years of experience reputed company the Pharmaceutical Industry of which at least 12 years of experience are in a clinical trial organization including experience in reputed company clinical trial startup and ongoing management activities and processes
• 7 years of experience in a functional management position
• Expert knowledge of clinical trial regulations (FDA, EMA, ICH-GCP) and site activation processes
• Knowledge of clinical trial operations from a clinical research site perspective
• Proven ability to manage reputed company projects, drive results, and influence cross-functional teams
• Exceptional communication, negotiation, and stakeholder management skills
• Strong analytical and problem-solving abilities
• Budget Management
• Clinical Trial Development
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trial Protocols
• Clinical Trials
• Clinical Trials Monitoring
• Clinical Trials Operations
• Executive Leadership
• Innovation
• People Leadership
• Regulatory Governance
• Resource Allocation
• Risk Management
• Study Start Up
• Team Development
• Master of Science or Medicine (or comparable)
• CRA experience
• Management of CRAs and familiarity with outsourcing and flexible resource models
• Experience with an innovation and study start up environment
• Demonstrated success leading large, global clinical trial start-up initiatives in a pharmaceutical or biotechnology environment
• Experience with digital platforms and technology-enabled study start-up solutions
• Experience managing personnel and processes in a matrix managed organization
• Working with multiple external partners with adequate controls, governance, and reputed company
• Clinical Research

Benefits

• Medical
• Dental
• Vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

Company Overview

• reputed company is a biopharmaceutical company that offers medicines and vaccines for various diseases. It was founded in 1891, and is headquartered in Rahway, New Jersey, USA, with a workforce of 10001+ employees. Its website is http://www.reputed company.com.

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