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Associate Director, Global Lead, Strategic Start Up

Company: Software Guidance & Assistance
Location: Orange
Posted on: November 22, 2020

Job Description:

Software Guidance Assistance, Inc., (SGA), is searching for an Associate Director, Global Lead, Strategic Start Up for a Contract assignment with one of our premier Pharmaceutical clients in CA. Responsibilities Advise and support teams in the development of the overall start up strategy, risk assessment, and contingency planning at a study, program and TA level. Assist teams with start-up strategy implementation and change management. Partner with key stakeholders to support start up milestones and KPIs, with a focus on critical path activities. Harmonize Start Up Tracking and provide Executive Level Start Up Metrics. Identify opportunities for increased efficiency andor cost savings by achieving consistencies across studies, programs and TAs. Provide leadership, support, and influence to ensure timely and quality start up deliverables. Provide leadership to Start Up Team in metrics development and implementation. Maintain operational oversight of assigned Study Start Up Specialists in all aspects of the Start Up Essential Document activities and CTA deliverables. Responsible for implementation of quality, efficient, and consistent approaches to carrying out tasks. Delivering training to departments, as necessary. Identifying opportunities for improvement and efficiency, and assisting with defining and implementing solutions. The Global Lead, Study Start Up is expected to be a subject matter expert Study Start Up requirements, activities and best practices, from the time of protocol concept through site activation. Required Skills A degree in a science or health-related discipline is preferred, and significant clinical experience with emphasis on study start up strategy is mandatory. Advanced understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based). Ability to travel up to 30 of the time. Excellent computer skills (Word, Excel, and PowerPoint), excellent interpersonal skills, ability to work effectively independently and with a team, and ability to influence and lead by example. SGA is a Certified Women's Business Enterprise (WBE) celebrating over thirty years of service to our national client base for both permanent placement and consulting opportunities. For consulting positions, we offer a variety of benefit options including but not limited to health dental insurance, paid vacation, timely payment via direct deposit. SGA accepts transfers of H1 sponsorship for most contracting roles. We are unable to sponsor for Right-to-Hire, Fulltime, or Government roles. All parties authorized to work in the US are encouraged to apply for all roles. Only those authorized to work for government entities will be considered for government roles. Please inquire about our referral program if you would like to submit a candidate for any of our open or future job opportunities. SGA is an EEO employer. We encourage Veterans to apply. To view all of our available job postings andor to learn more about SGA please visit us online at www.sgainc.com httpwww.sgainc.com .

Keywords: Software Guidance & Assistance, Orange , Associate Director, Global Lead, Strategic Start Up, Other , Orange, California

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