GSK - Study Delivery Lead - Clinical Research

Site Name: Bengaluru Luxor North Tower

Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Clinical Study Management Manager could be an exciting opportunity to explore.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: competitor intelligence research, collation and dissemination of data, etc

- 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 study(ies) 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.

Key Responsibilities:

- 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 reporting tools and communicates progress to Project 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 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 quality

- 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.

- Project manages study activities including

- 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

- Manages study communications and issue escalation within the team, and communicates progress and escalates issues to the Project Delivery Lead when appropriate

- Ensure all systems are correctly populated and up to date

- 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, analyse 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.

Why you?

Basic Qualifications:

- We are looking for professionals with these required skills to achieve our goals:

- 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 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.

- Knowledge of French an asset

- In-country CRA / monitoring/ sites experience an asset

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.

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