<p>The <b>Study Start Up Lead</b> is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. The role is the accountable person and single point of accountability for the study Start Up Metrics.</p><p></p><p>This position works directly with Study Start Up Associate Director, LDL Managers, LDL, Global SSU Managers, CRO FSP (Functional Service Provider) CRA/CSA Managers in setting priorities and expectations for Study Start-Up.</p><p></p><p><b>Key Responsibilities</b></p><ul><li><p>Accountable to lead timely Start Up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according to Country regulations, GSK SOPs and GCP</p></li><li><p>Serves as the operational point-of-contact between the central GSK study team, global SSU team and within-country study team for Study Start Up activities</p></li><li><p>Ensures that critical study timelines related to study start up activities within-country are accurately forecasted</p></li><li><p>Accountable for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear internal team communication and documentation</p></li><li><p>Accountable via the Study Start-up Coordinators for delivery of country feasibility, site selection, recruitment planning, site training and regulatory package completion</p></li><li><p>Facilitates communication within the clinical team (e.g. Budget and Contracts team, Clinical Supplies, Regulatory, and monitoring) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met</p></li><li><p>Accountable for study recruitment vendor relations and engagement including strategy for country recruitment strategy</p></li><li><p>Accountable for including clinical trial diversity planning in country and site feasibility and selection</p></li><li><p>Responsible for standardizing processes, identifying, and sharing best practices and representing his/her team on internal and cross functional process improvement teams</p></li><li><p>Consulted for administrative approach to PEER sites</p></li><li><p>Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the development of clinical research activities / investigator partnerships</p></li><li><p>Is the point of contact for the FSP CRO Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice</p></li><li><p>Accountable for managing locally all clinical operational aspects related to the Regulatory Vault approach</p></li></ul><p></p><p><b>Why you?</b></p><p></p><p><b>Basic Qualifications:</b></p><p></p><p><i>We are looking for professionals with these required skills to achieve our goals:</i></p><ul><li><p>Bachelors in a General Science Degree (i.e. life science, medicine, clinical research, pharmacy)</p></li><li><p>5 or more years’ work experience in clinical operations</p></li></ul><p></p><p><b>Preferred Qualifications:</b></p><p></p><p><i>If you have the following characteristics, it would be a plus:</i></p><ul><li><p>Previous Oncology and Study Start Up experience strongly preferred</p></li><li><p>Profound operational knowledge of clinical research with experience in all stages of study lifecycle and understanding of R&D process</p></li><li><p>Good written and verbal communication skills in local language and in English</p></li><li><p>Strong computer skills: advanced/expert level of MS Office (PowerPoint, Excel, Word and Outlook)</p></li><li><p>Working knowledge of current clinical trial regulation</p></li><li><p>Solid experience regarding management of contracts</p></li><li><p>Given the nature of the job and accountabilities for local execution, project management skills are required to coordinate across all deliverables and manage local study teams to meet time, cost and quality requirements.</p></li></ul><p></p><p>#LI-REMOTE</p>The US annual base salary for new hires in this position ranges from $115,500 to $192,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">leave. If</span> salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.<p></p><p>Please visit  <a href="http://us.gsk.com/media/7992/ustrataglance-jobpostings.pdf" target="_blank" rel="noopener noreferrer"><span style="color:#0000ff"><u>GSK US Benefits Summary</u></span></a> to learn more about the comprehensive benefits program GSK offers US employees. </p><p></p><p></p><p><b>Why GSK?</b></p><p><b>Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.</p><p></p><p>People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p>Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at <a href="mailto:HR.AmericasSC-CS@gsk.com" target="_blank" rel="noopener noreferrer"><span style="color:#0000ff"><u><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">HR.AmericasSC-CS@gsk.com</span></u></span></a> where you can also request a call. </p><p></p><p>Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the <a href="https://www.gsk.com/en-gb/careers/how-we-hire/frequently-asked-questions/" target="_blank" rel="noopener noreferrer"><span style="color:#0000ff"><u>link</u></span></a> where you will find answers to multiple questions we receive </p><p></p><p>GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.</p><p></p><p><b>Important notice to Employment businesses/ Agencies</b></p><p>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.</p><p></p><p>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 the Centers for Medicare and Medicaid Services (CMS) website at <a href="https://openpaymentsdata.cms.gov/" target="_blank" rel="noopener noreferrer"><span style="color:#0000ff"><u><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">https://openpaymentsdata.cms.gov/</span></u></span></a></p>