Study Delivery Lead

GlaxoSmithKline - Rockville, MD (30+ days ago)4.2

Your Responsibilities:
The Study Delivery Lead (SDL) is the single accountable for the execution and the delivery of the
study to time, budget and quality as defined in the Development Plans (Clinical, Epidemiology, Global
and local studies) and study protocol, and in adherence with GCP-ICH guidelines, GSK Vaccines
control documents and within regulatory requirements.

The SDL is the single point of contact for operational planning and design, operational feasibility and delivery of their studies from commit to study idea until publication. He/she coordinates other functions (clinical and non-clinical) at study level.

The scope of work includes leadership, study management, oversight and project management of both global and in-country activities, as well as authorship of some study documents.

They work closely with the Clinical Research Development Leaders (CRDL), Epidemiologist (central and regional) and GSK Country Medical Directors (for Local studies), who are responsible for the medical and scientific aspects, scientific design of the protocol and scientific outputs including data interpretation and reporting.

In order to maintain the right expertise and provide the best support, there will be dedicated SDLs for
most of the clinical and epidemiology/supported studies.

Within the Clinical Evidence Generation Platform, the SDL supports process improvements and
participates in working groups as applicable.

The SDL interacts with other SDLs to share best practices, lessons learned and support process
improvement with participation in working groups as applicable.

For studies of greater complexity, several SDLs can be appointed to support a senior SDL in the
delivery of the study.


Accountable and responsible for delivery of study as defined by protocol and according to agreed
timelines and budget set in the Development Plan (Clinical, Epidemiology development plans,
including local studies):
- Define study operational model
- Lead clinical and non-clinical functions to ensure study delivery and take operational decision
at study level (will refer to Project Delivery Lead as needed)
- Develops study plan and forecast, including detailed schedule and budget
- Develop and maintain Study Risks management plan
- Define resource requirements and ensure appropriate resourcing (including outsourcing)
- Tracks delivery to time, cost and quality, including maintenance of standard tools such as
iPlan, eTrack and SAP
- Prepare study management, monitoring and communication plans (including definition of study
essential data for adaptive monitoring)
- Ensure appropriate study oversight including study kick off meeting(s), regular TC with
LOC/CRO, review protocol deviations, escalation process and ensure appropriate follow-up
actions are taken
- Set up of dashboard, regular review of trial monitoring tools (TMTs), key risk indicators (KRIs),
key performance indicators (KPIs) and other study related reports / tools
- Establishes study performance

Leads and oversees operational activities in study design and study execution including
October , 2015 Page 2 of 5
- Inputs to concept protocol and protocol development to ensure optimal operational design and feasibility, and co-ordinates study execution plan health check
- Coordinates study feasibility
- Participates in country and site selection, with reference to pre-selection decisions made at
Development Plans level
- Ensures appropriate training of country staff and sites on operational matters - Prepare/deliver
Investigators/monitors meeting (when applicable)
- Develops and ensures on-time execution of supportive documents, plans and manuals
including the study management and monitoring plan, study procedures manuals, data quality
plan, core operational packages for submission and for countries
- Ensures functional strategy and plans are developed, maintained and executed including
clinical supplies, sample management, data management, document management and
- Ensuring that appropriate documents are available to regional teams for timely submission to
Ethics Committees and/or Regulatory Authorities according to local requirements
- Responsible for vendor management activities including selection and contract development
- Responsible for Study-level oversight, communications and issue management
- Provides input to the clinical study report / module appendix
- Sign-off essential study documents
- Ensure appropriate documentation of Oversight is available in the TMF at all times, ensure
completion of Trial Master File (collect of Essentials doc…), ensure archiving for paper file
- Ensure collection and review of Protocol deviations and ensure review & analysis of Data
Quality Escalate as appropriate

Ensures the study is delivered with quality, in accordance with ICH/GCP and regulatory requirements
- Ensure development and management of the Study Quality Management Plan and conduct
related quality assessment, endorse proposal for site assessments/audits, analyze and follow
up assessment reports
- Ensure a study-level risk assessment is performed and identified risks are appropriately mitigated
- Ensure issues escalation and management up to resolution
 Typically responsible for 1-4 trials of average design and protocol complexity (can be more for
Supported or very simple studies)
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
Coordinate and manage indirectly up to 15 central and local clinical operation functions and others cross-functional experts involved in the preparation and delivery of the studies
Why You?

BS/BA Degree in Pharmacy, Chemistry, Bio Engineering, Biology, Biomedical Sciences, or Project Management

6 years of significant experience in managing clinical research studies, clinical operations or equivalent. Has a very good 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, including team leadership

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

Good 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

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. Knowledge of French an asset
In-country CRA / monitoring/ sites experience an asset
Preferred qualifications:
Master, Post graduate degree in a life science field desirable
Why GSK?:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. 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.