Director, Clinical Data Management Sciences

ViiV Healthcare ,
Stevenage, Hertfordshire
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Job Description

ViiV Healthcare has an exciting opportunity as the Director of Clinical Data Management Sciences. This role will focus on the following areas: * Oversee CDMS activities performed via partner SLPs (GSK, Pfizer) and trial networks (eg, HPTN, IMPAACT, ACTG and others) (35%) * Contribute to and lead initiatives to improve CDMS efficiency and quality (25%) * Review and develop CDMS policies, procedures and related guidance documents (20%) * Conduct, foster and CDMS activities as needed to support ViiV business needs (20%) This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: * Serves as the single point of contact and advocate for ViiV CDMS in proposing, negotiating and managing delivery of CDMS expertise to enhance business processes, including interface with medical, safety, virology, discovery research and translational medicine * Drives efforts to improve quality and efficiency of CDMS activities * Leads initiatives to improve CDMS quality, efficiency or adherence to standards, including cross-functional initiatives across multiple departments via review and development of procedural documents * Has broad recognition for strong technical competency in key areas of CDMS * Provides state-of-the-art CDMS knowledge & skills for process improvement initiatives * Effectively monitors quality of CDMS deliverables from partner SLPs (GSK, Pfizer) * Supports strategy for developing and embedding CDMS standards across functions in accordance with internal and industry wide best practices and standards * Serves as the ViiV contact and advocate for the SLP (GSK, Pfizer) CDMS function in proposing, negotiating and managing CDMS expertise * Engages in impactful interactions with regulatory agencies, external experts and/or other organizations regarding CDMS strategy, design and delivery * Leads, or contributes to industry-wide initiatives as part of external working groups/committees * Has the ability to build credibility and presence with customers at all levels of support * Drives CDMS efforts to improve data visibility, quality and efficiency of flow from start-up through the reporting and archiving stages of studies and system development including data re-use and data visualization strategies (e.g., development of dashboards, tools, data warehousing). * Performs and/or CDMS activities across multiple assets to deliver high-quality CDMS deliverables Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelor's, Masters or PhD or equivalent experience with extensive practical experience or proven experience at the expert level * Ten years of related job experience * Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change. * Effective written and verbal communication skills * Broad understanding of external landscape with respect to role and its related functions * Experience in leading teams and business improvement efforts with positive results. * Experience in applying creative thinking and analysis skills to improve or solve business problems. * A solid understanding of regulatory and esubmission and publishing processes (e.g. 21 CFR Part 11) * Ability to manage conflicting demands and priorities and to negotiate successfully * Demonstrated ability to manage the outsourcing or externalization of CDMS work packages in the clinical trials setting (e.g.working with CROs, academic institutions) Preferred Qualifications: If you have the following characteristics, it would be a plus: * PhD preferred * Experience with/understanding of HIV or infectious disease US WORK AUTHORIZATION/CITIZENSHIP IS REQUIRED FOR THIS ROLE. VISA SPONSORSHIP IS UNAVAILABLE FOR THIS POSITION. Why ViiV? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As ViiV focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. * Managing individual performance. * Creating a performance culture and driving results, prioritisation, execution, delivering performance. * Setting strategic direction and leading on-going organisational transformation. * Building a resilient organisation. * Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. * Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-75

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