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Senior Study Delivery Lead

Company: GlaxoSmithKline
Location: Rockville
Posted on: September 13, 2020

Job Description:

Job description Site Name: USA - Maryland - Rockville

Posted Date: Jul 17 2020

US work authorization is required for this role. Sponsorship is not available for this position

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

The Senior Study Delivery Lead (sSDL) is the Project Manager of a study. As such, the sSDL is accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the Development Plans (Clinical, Epidemiology, Global and Local studies), in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, GSK Vaccines control documents and within regulatory requirements.

The sSDL has the accountability for 1 or several complex studies, and perform the full set of activities of the Study Delivery Lead (see Job description of SDL) and has the ability and the seniority to manage the delivery of any types of studies (different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology and local studies, complex countries/regional environment).

The sSDL is able to develop and follow the most efficient operating model for supported/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)

The sSDL is able to manage large & multidisciplinary study team (up to 30 team members) and manages studies with a budget that can be >10 M€ with more than 15000 human subjects for studies.

The sSDL may have the responsibility for a clinical development sub-program and therefore can be contributor to the program strategy development and program delivery oversight

The sSDL is the reference and role model within study delivery lead team

The sSDL is ensuring the translation of scientific objectives in the Study Management Plan. By using integrated processes, tools and measures the sSDL ensures the study oversight, delivery of the study on time, according budget and with quality, using a risk based approach methodology: The sSDL develops a study management plan including forecast, detailed schedule, budget and Quality Management Plan

The sSDL ensures a study-level risk assessment is performed, ensures that identified risks are appropriately mitigated . The sSDL develops and maintains Study Risks Management Plan

The sSDL 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

The sSDL prepares monitoring and communication plans (including definition of study essential data for adaptive monitoring)

The sSDL ensures issue escalation and management up to resolution. The sSDL communicates progress and escalates issues to the Project Delivery Lead when appropriate

The sSDL defines resource requirements and ensure appropriate resourcing (including outsourcing)

The sSDL tracks delivery to time, cost and quality, ensures maintenance of standard tools such as iPlan, eTrack and SAP.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

Bachelor’s Degree - General Science or Life/Health related Science Degree

8 + years of significant experience in managing complex clinical research studies, clinical operations or equivalent.

2 years of experience in regional clinical study leadership desirable (field experience)

Preferred Qualifications: If you have the following characteristics, it would be a plus:

Master, Post graduate degree in a life science field desirable

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, including team leadership

Why GSK? Our values and expectations are 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 GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

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

*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.

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.

Full-Time, Rockville, Maryland, United States Senior Study Delivery Lead Full-Time, Rockville, Maryland, United States Start a career with purpose GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer.

Annual bonus based on company performance

Long term incentives and pension plan

Learning and career development

Access to healthcare & wellbeing programmes

Keywords: GlaxoSmithKline, Rockville , Senior Study Delivery Lead, Other , Rockville, Maryland

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