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Sr. Manager / Associate Director Clinical Performance Management & Effectiveness

Job Title: Sr. Manager / Associate Director Clinical Performance Management & Effectiveness
Reports To: Sr. Director, Clinical Development Operations
Location: Cambridge, Massachusetts

Summary
This newly created position reports into the Sr. Director Clinical Development Operations and will assisting in shaping the Compliance and Operational Excellence Team. The individual will provide the leadership, subject matter expertise, and strategy to drive the KPI/RPI management and reporting process for outsourced model.?? This includes root cause analysis, KPI periodic reporting, Leadership presentation material, implementing process improvement initiatives, and training / communication.? The individual will collaborate cross-functionally with our CROs / Vendors, and the internal Clinical Development teams to recommend key improvements to drive operational effectiveness.?
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Primary Responsibilities


  • Responsible for partnering with heads of various Clinical Development areas and team members to implement a strategic and cohesive approach to KPIs / QRIs, overall culture, and training requirements


  • Working with Development team on defining metrics and recommending improvements based on SOP and real-life processes to ensure KPI is meaningful and actionable


  • Monitor ongoing performance, identify and resolve gaps/barriers to success


  • Collaborating with Clinical Development and vendors with automating data sources and improving accessibility for the team


  • Advise senior management of critical quality and compliance related issues and assist with corrective actions to mitigate quality and compliance risks


  • Improving the tools and communications to drive KPI ownership


  • Conducting training sessions to improve KPI adoption


  • Assist with audits / inspections as necessary


  • Assist Clinical Teams in the development of appropriate audit responses and corrective & preventive action plans



Qualifications
Must enjoy working in a fast-paced, innovative environment. Must be flexible, proactive, efficient, and team player.?? This is a highly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills.? Working knowledge of Clinical Development Activities and ICH-GCP guidelines.


  • Bachelor's Degree is required.??An advanced degree is highly preferred


  • 7+ years of experience gained with a CRO, biotech, or pharmaceutical company


  • 5+ years of relevant experience in roles with an emphasis on clinical / business operations or managing projects of performance improvements


  • Ability to work, lead, coordinate, and manage activities to drive change within the organization


  • Knowledge and preferably experience in global clinical trial execution and operations


  • Working knowledge of clinical trial management activities in an outsourced CRO model


  • Strong strategic, critical thinking skills with ability to influence senior leadership


  • Excellent communication skills, verbal, written and presenting in English as well as diplomacy, cross-cultural and team skills


  • Ability to management multiple projects simultaneously, prioritize workload for teams and function in fast-paced environment


  • Mindset of continuous improvement



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Company Description:

About Ascent:


Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.


If you are ready to propel your career to new heights†read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.




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