Associate Director, Clinical Development Compliance, SOPs, Disclosure

Associate Director, Clinical Development Compliance
Please apply if interested or contact Josh Johnson at jjohnson@ascentsg.com
This newly created position reports into the Sr. Director Clinical Development Operations. He/She will provide the leadership, subject matter expertise, and strategy to drive the optimal clinical development oversight, GCP compliance, SOP, and Disclosure management.
This role will collaborate cross-functionally to understand organizational needs, drive CAPA Management, govern SOP process, manage Disclosure vendor, assist with inspection preparation, support implementations of future capabilities that overall, enhance the effectiveness of compliant clinical trial execution.
Furthermore, this individual will create an effective interface with Clinical Quality Assurance to ensure good clinical practice (GCP) compliance across the global clinical development organization.?
Primary Responsibilities

  • Responsible for partnering with heads of various Clinical Development areas to implement a strategic and cohesive approach to Clinical Development GCP Compliance, overall culture, and training requirements

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

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  • Assist Clinical Quality Assurance, as needed, during vendor audits and Support Clinical Operations during oversight assessments

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  • Oversee and optimize the Standard Operating Procedures (SOPs), processes, training, and rollout across Clinical Development

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

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  • Support / Lead inspection preparation activities as required

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  • Project management coordination of Clinical Trial Disclosure and Transparency activities to ensure trials are disclosed in accordance to global applicable laws, regulations, and policies

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  • Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials

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  • Build a Team and Manage to a growing portfolio?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. Extensive knowledge of ICH-GCP guidelines and major Health Authority regulations.

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

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

  • 5+ years of compliance, GCP Function, or clinical project leadership

  • Prior inspection readiness and oversight experience is highly desired

  • This is a highly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills

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

  • Experience with delivering effective CAPA management solutions

  • 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

  • Ability to successfully manage, build, and lead a team

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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