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Associate Director Study Delivery Lead

Rockville, MD
Closing date
Jan 21, 2022

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Health Sciences, Medicine
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Site Name: USA - Maryland - Rockville Posted Date: Jan 13 2022 Would you like to be part of GSK's emerging clinical leadership, with an opportunity to accelerate quality efforts across clinical operations on national and global scale? If so, this could be an excellent opportunity to explore. As a Associate Director Study Delivery Lead, you will be responsible for leading Global In-Country Clinical operations teams to improve quality processes and evolve the ways of working to optimize clinical operations and foster stronger quality relationships with the sites. You will also support the Director of Quality, Training and Capability Development with all required activities to achieve business goals. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… • Lead and participate in cross functional teams to assess transformational initiatives and tools to help simplify ways of working and accelerate portfolio delivery Ensures the translation of scientific objectives in the Study Management Plan. Uses integrated processes, tools and measures to ensure the study oversight, delivery of the study on time, according budget and with quality, using a risk-based approach methodology Develops a study management plan including forecast, detailed schedule, budget and Quality Management Plan Ensures a study-level risk assessment is performed, so that the identified risks are appropriately mitigated.Develops and maintains Study Risks Management Plan Ensures development and management of Study Quality Management Plan and conduct related quality assessment, endorses proposal for site assessments/audits, analyze and follow up assessment reports Prepares monitoring and communication plans (including definition of study essential data for adaptive monitoring) Ensures issue escalation and management up to resolution. Communicates progress and escalates issues to the Asset Lead when appropriate Defines resource requirements and ensures appropriate resourcing (including outsourcing) Tracks delivery to time, cost and quality, ensures maintenance of standard tools such as iPlan, eTrack and SAP. Sets up the Study Dashboard to facilitate the integrated study oversight. Each Study Core Team member has his own accountability to ensure control and monitoring of his departmental plans. Accountable for the study budget Ensures appropriate documentation of Oversight is available in the TMF at all times, completion of Trial Master File (collect of Essentials doc…), and archiving for paper file... In partnership with the Clinical Research Development Lead (CRDL), Epidemiologist, Country Medical Directors (for local studies), co-ordinates all members of the study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time Leads a multifunctional team to ensure study Oversight, study delivery and takes operational decisions at study level (will refer to Asset Delivery Lead as needed). Ensures appropriate study oversight including study kick off meeting(s), regular TC with LOC/CRO, reviews protocol deviations, escalation process and ensure appropriate follow-up actions are taken Develops and maintains, with the Study Core team, the study dashboard including key risk indicators (KRIs), key performance indicators (KPIs) and other study related reports / tools Communicates progress to Asset Delivery Lead and study team Leads and oversees operational activities in study design and study execution including Inputs to concept protocol and protocol development to ensure optimal operational design Accountable to ensure that the study feasibility process and the country/ies allocation are optimal in regards of the project strategy. Accountable to ensure that the study execution health check is the most optimal in regards of the project strategy. Ensures functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality. Each study core team member keeps his own accountability to ensure planning and execution of his departmental plans. Participates in country and site selection, with reference to pre-selection decisions made at Development Plans level In coordination with the study core team, ensures that appropriate documents are available to regional teams for timely submission to Ethics Committees and/or Regulatory Authorities according to local requirements Ensures appropriate training of country staff and sites on protocol and project specific matters - Prepare/deliver monitors meeting (when applicable) Develops and ensures on-time execution of supportive documents, plans and manuals including the monitoring plan, study procedures manuals, core operational packages for submission and for countries Responsible for vendor management activities including selection and contract development when outsourced activities are owned by the SDL Develops and follows the most efficient operating model for collaborative studies, to manage appropriately the risks linked to supported/collaborative studies and has experience and skills to manage all associated requirements - Same for the management and oversight of outsourced studies (including RFP/Bid defense and contract management) Provides input to the clinical study report / module appendix As part of his/her development, the Associate may contribute to a small clinical development sub-program operational strategy and takes the oversight of its delivery Responsible for >4 trials of average to very high design and protocol complexity Maintains expertise in GCP and in clinical study management methodology and support process improvement initiatives and shares best practices within the SDL team and beyond. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in the areas of General Science or Life/Health Science 6 years of experience in managing clinical research studies, clinical operations or equivalent Experience coordinating and managing indirectly up to 30 central and local clinical operation functions and others cross-functional experts who are involved in the preparation and delivery of the study(ies) 8+ years of significant experience in managing complex clinical research studies, clinical operations or equivalent. Advanced understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements. 2+ years of experience in regional clinical study leadership desirable (field experience) Strong skills and experience in project management and tools In depth knowledge of GCPs and ICH guidelines Excellent communication and presentation skills Solid experience working in teams with a broad range of cultures Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives Demonstrates an excellent understanding of the clinical study , drug development , sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs Strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available) Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others Able to set and manage priorities, performance targets and project initiatives in a global environment Operational expertise in risk management and contingency planning Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency Acts as role model in line with GSK Vaccines core values and Expectations Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK Vaccines systems/software Demonstrates conceptual, analytical and strategic thinking Effective at problem solving and conflict resolution Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master, Post graduate degree in a life science field (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Project Management In-country CRA / monitoring/ sites experience an asset Knowledge of French an asset 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 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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