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13/04 Kimberlee
HR Manager at GSK

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GSK - Senior Study Delivery Lead - Clinical Research (8-13 yrs)

Bangalore Job Code: 913494

- 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.

The Senior Study Delivery Lead (sSDL) is the single accountable for the execution and delivery of complex studies 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 sSDL has the single 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 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) as the sSDL has full credibility vis a vis external partners and 3rd parties.

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

- The sSDL may have 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

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

- Accountable for 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 protocol and project specific 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 >4 trials of average to very high design and protocol complexity

- 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) as the sSDL has full credibility vis a vis external partners and 3rd parties.

- As part of his/her development, the sSDL may contribute to a small clinical development sub-program operational strategy and takes the oversight of its delivery

- 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:

- University Scientific Degree

- 8 years of significant experience in managing complex 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

- 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.

- 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. 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

Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

Note: For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.

Women-friendly workplace:

Maternity and Paternity Benefits

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