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Study Delivery Lead

Research Triangle Park, North Carolina; Atlanta, Georgia; Baltimore, Maryland; Waltham, Massachusetts; New York, New York; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Closing date
Jan 27, 2022

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Health Sciences, Medicine
Organization Type
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Site Name: USA - North Carolina - Research Triangle Park, UK - London - Brentford, USA - Georgia - Atlanta, USA - Maryland - Baltimore, USA - Massachusetts - Waltham, USA - New York - New York, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Dec 14 2021 Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Clinical Development Lead role could be an exciting opportunity to explore. The S&PC Supported Studies Study Delivery Lead is responsible/ accountable for the set-up, coordination and delivery of Investigator Sponsored (ISS) and Supported Collaborative Studies (SCS) from the Respiratory and Immunology area, specifically: Proactively managing end to end study delivery for ISS and/or SCS, providing operational support for delivery of assigned studies ensuring they are conducted in accordance to GSK SOPs, relevant legislation, on time and within budget from concept to completion. Working with the GSK supplies team/s to manage commercial and clinical supplies. Working with the finance team/s to effectively forecast budget, track invoicing/payments and track actual spend. Partnering to complete contracting activities such as due diligence and ABAC checks. Study timeline and milestone management. Manage end to end KPI reporting internally on individual study status. Key attributes for this role include operational credibility, demonstrated ability to input to and influence studies/projects through operational expertise, and demonstrated excellence in stakeholder management. This job requires the ability to lead and drive change, strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change and curiosity. Essential behaviors valued include: The ability to lead and inspire others, continuous improvement and learning, and effectiveness at building networks of partners and stakeholders. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Operational point of contact for the external Study Sponsor and Internal Stakeholders: Primary point of contact with SS Coordinators and other key stakeholder groups including data management, safety, biostatistics, legal, compliance, project management. Facilitate engagement between Sponsor and GSK scientific and contracting teams as required Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate. Interact and build strong relationships with Country Local operating company, MSLs and matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation Interact effectively across boundaries with other global functions using influencing and relationship-building skills and working together to overcome issues as required. Provide regular progress updates to key stakeholders and escalate issues as required The position may also include: Lead and drive significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Be responsible for implementing new business processes and strategies. Why you? We are looking for someone who will focus of the following key behaviours Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness Basic Qualifications: Bachelor's degree in Life Sciences or related field Minimum of 3 years' experience in clinical operations One or more years experience of working in academic partnerships and/or external alliances with proven clinical project or alliance management skills. One or more years experience working with the principles of quality, safety, risk management and compliance (ICH and GCP) Preferred Qualifications: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience Experience of Respiratory and Immunology Drug Development Excellent leadership skills. Proven ability to build and nurture relationships with a range of stakeholders Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK *This is a job description to aide in the job posting but does not include all job evaluation details. . If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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