Associate Director, Clinical Operations

14 hours ago

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Description

• Provide oversight, management, and leadership of Clinical Operations (Project Management) and Trial Master File Management. • Supervise, coach, and mentor team members reporting to this position. • Work with each team member to set clear job expectations, assess training needs, and ensure team members receive training as needed. • Develop and maintain long-term professional relationships with sponsors and vendors. • Oversee quality, accuracy, and timeliness of the deliverables of the Clinical Operations teams. • Interact with sponsors and vendors and participate in meetings, as necessary, to support and maintain success. • Develop and manage multidisciplinary project team activities. • Assess project issues and propose resolutions to the project team, Director of Operations, CPC Leadership Committee, and the sponsor. • Provide regular updates to supervisor on all staff, key performance indicators, timelines, and deliverables as necessary. • Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Clinical Operations on individual employee, functional area, and project metrics. • Provide strategic input into innovations and contribute to the achievement of functional area goals. • Develop and review/approve applicable Clinical Operations policies, Standard Operating Procedures and Work Instructions. • Oversee compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs) as well as applicable regulations and guidelines. • Function as an Executive Clinical Operations Manager for assigned projects. • Provide mentoring, support, and back-up for all relevant project activities. • Ensure overall quality and project services. • Assist Business Development with benchmarking for budgets and development of proposals and service agreements.

Requirements

• Nursing or BA/BS in a scientific field preferred but not required. • A minimum of 7 years of experience in clinical trials, or equivalent experience. • A minimum of 1 year of supervisory experience. • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. • Excellent interpersonal communication skills, good problem solving and organizational skills and great attention to detail. • Experience with MS Office including Project, Access, PowerPoint, SharePoint, Word, and Excel. • Ability to work as a member of a team and to organize, instruct and supervise staff, while promoting group effort and achievement. • Ability to manage conflicts and resolve problems effectively. • Ability and willingness to travel up to 15%.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules