Director, Centralized Monitoring (In-House Studies)

Posted:
10/1/2024, 1:53:27 AM

Location(s):
Karnataka, India

Experience Level(s):
Senior

Field(s):
Operations & Logistics

Would you like to be part of GSK’s emerging clinical leadership, with an opportunity to lead development efforts across therapeutic portfolios?  If so, this could be an excellent opportunity to explore.

As a Clinical Study Management Director, you will lead the clinical study operational efforts, providing leadership on clinical development and strategic issues that impact the success of our Medicine Development units.

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

• Accountable to ensure all studies assigned to the Local Operating Country (LOC) are delivered to quality and agreed budget within the required timelines.

• Responsible to work with the LSMs (Local Study Managers) to resolve and escalate issues and assess risk.

• Responsible for leading the team of LSMs, CRAs (Clinical Research Associates - as applicable) and CSSs (Clinical Support Specialists - as applicable) by providing training, coaching and mentoring including line and performance management.  Develops staff competencies and proactively identifies skill gaps in a changing environment

• Provides oversight and coaching of staff to ensure strategic operational input into clinical development plans, including budget, feasibility of study design, conduct and data delivery for early and late phase clinical programs.

• Responsible to work with LSMs to oversee the development of study budgets, ensure timely execution of contract and payments.  Accountable for budgets up to $30 million in external department spend per annum.

• Responsible for standardizing processes, identifying and sharing best practices and representing local study management and study support functions on internal and cross functional process improvement teams.

• Responsible for effective resource utilization so that studies are resourced appropriately.

• Develop operational strategies for investigator site allocation that will ensure appropriate utilization of high-demand, limited-supply resources across the portfolio.

Why you?

Basic Qualifications:

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

  • Bachelor’s Degree
  • Solid understanding of R&D and drug development process
  • 8+ years of clinical research experience
  • Experience across a range of Phase I – IV studies.
  • Solid understanding of clinical practices and disease/therapy areas.
  • Demonstrated ability to manage clinical study resources and activities including multiple products or indications.

Preferred Qualifications:

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

  • Masters Degree or PhD preferred
  • 5 years of clinical study management or equivalent management experience.
  • Familiarity with Key Opinion Leaders and industry experts across therapy areas

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:

  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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