Manager, Clinical Study Support

GSK   •  

Providence, RI

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 41 days ago

The Manager, Clinical Study Support provides leadership, direction and co-ordination of a team to ensure delivery of clinical support activities. Working within the US Clinical Operations leadership team and in conjunction with other teams, leads a specialist area and supervises a local team that will be supporting GSK sponsored, Phase I-IV studies and projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Responsible in partnership with the CSS Director for ensuring effective regional implementation and embedding of the US local Clinical Study Support Team
  • Accountable for leading Direct Reports (as applicable) by providing training, coaching and mentoring including line and performance management. Develop staff competencies and identify skill gaps to ensure their ability to deliver to business objectives.
  • Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality. Where appropriate this may include aligning resource to a specific TA/Asset
  • Responsible for the identification of appropriate resources to support workload and personal development opportunites for regional Clinical Study Support staff to support R&D strategies within US Clin Ops
  • Build strong partnership with other stakeholders and departments to enable in-stream, end to end process flow, document preparation and archiving, site support, etc.
  • Responsible in a partnership with the CSS Director for ensuring that Clinical Study Support staff adhere to appropriate Regulatory e.g. ICH GCP, GSK Policies, SOPs, standards and have relevant documentation in place and tracked to demonstrate this. In addition, responsible for ensuring staff work to the highest quality that enables study teams to be inspection ready
  • Responsible in a partnership with the CSS Director for resource allocation and oversight of FSP providers
  • Responsible for ensuring that Regional Clinical Study Support staff apply their specialized knowledge of GSK systems processes and procedures, when conducting GSK sponsored studies and projects to agreed quality, timelines, milestone and budget
  • Proactively interpret data, draw valid conclusions and recognize complex underlying issues; escalate or propose information management solutions to manage risks to study timelines, budgets and goals
  • Design and drive the testing and implementation of key organizational improvement initiatives

Why you?

Basic Qualifications:

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

  • Bachelor's Degree in Health Sciences or Business Administration/Finance/Economics
  • A minimum of 5 years or more experience in a similar role within the pharmaceutical/medical industry
  • Proficient in clinical systems/IT environment (GoBalto, Veeva Vault, eTrack, PRISM)
  • Excellent leadership, networking, and communication skills to work effectively in a highly matrixed environment

Preferred Qualifications:

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

  • High degree of understanding of global and local clinical business processes
  • Proven ability to work effectively across inter-disciplinary teams
  • Strong finance/business acumen and understanding of clinical finance processes
  • Demonstrated track record of success in planning/managing and embedding strategic initiatives
  • Must have a performance mindset and can work tenaciously through difficulties to achieve clear results.
  • Must be able to operate and influence across business units and management levels to drive change and achieve results.
  • Experienced change agent who challenges status quo
  • Goal oriented self-starter with strong analytical problem-solving skills
  • Strong verbal and written communication skills
  • Demonstrated ability to innovate and achieve results
  • Solid understanding of local regulations, ICH-GCP guidelines and GSK written standards.
  • Acts as role model in line with GSK core values and behaviors

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 oppThe Manager, Clinical Study Support provides leadership, direction and co-ordination of a team to ensure delivery of clinical support activities. Working within the US Clinical Operations leadership team and in conjunction with other teams, leads a specialist area and supervises a local team that will be supporting GSK sponsored, Phase I-IV studies and projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Responsible in partnership with the CSS Director for ensuring effective regional implementation and embedding of the US local Clinical Study Support Team
  • Accountable for leading Direct Reports (as applicable) by providing training, coaching and mentoring including line and performance management. Develop staff competencies and identify skill gaps to ensure their ability to deliver to business objectives.
  • Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality. Where appropriate this may include aligning resource to a specific TA/Asset
  • Responsible for the identification of appropriate resources to support workload and personal development opportunites for regional Clinical Study Support staff to support R&D strategies within US Clin Ops
  • Build strong partnership with other stakeholders and departments to enable in-stream, end to end process flow, document preparation and archiving, site support, etc.
  • Responsible in a partnership with the CSS Director for ensuring that Clinical Study Support staff adhere to appropriate Regulatory e.g. ICH GCP, GSK Policies, SOPs, standards and have relevant documentation in place and tracked to demonstrate this. In addition, responsible for ensuring staff work to the highest quality that enables study teams to be inspection ready
  • Responsible in a partnership with the CSS Director for resource allocation and oversight of FSP providers
  • Responsible for ensuring that Regional Clinical Study Support staff apply their specialized knowledge of GSK systems processes and procedures, when conducting GSK sponsored studies and projects to agreed quality, timelines, milestone and budget
  • Proactively interpret data, draw valid conclusions and recognize complex underlying issues; escalate or propose information management solutions to manage risks to study timelines, budgets and goals
  • Design and drive the testing and implementation of key organizational improvement initiatives

Why you?

Basic Qualifications:

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

  • Bachelor's Degree in Health Sciences or Business Administration/Finance/Economics
  • A minimum of 5 years or more experience in a similar role within the pharmaceutical/medical industry
  • Proficient in clinical systems/IT environment (GoBalto, Veeva Vault, eTrack, PRISM)
  • Excellent leadership, networking, and communication skills to work effectively in a highly matrixed environment

Preferred Qualifications:

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

  • High degree of understanding of global and local clinical business processes
  • Proven ability to work effectively across inter-disciplinary teams
  • Strong finance/business acumen and understanding of clinical finance processes
  • Demonstrated track record of success in planning/managing and embedding strategic initiatives
  • Must have a performance mindset and can work tenaciously through difficulties to achieve clear results.
  • Must be able to operate and influence across business units and management levels to drive change and achieve results.
  • Experienced change agent who challenges status quo
  • Goal oriented self-starter with strong analytical problem-solving skills
  • Strong verbal and written communication skills
  • Demonstrated ability to innovate and achieve results
  • Solid understanding of local regulations, ICH-GCP guidelines and GSK written standards.
  • Acts as role model in line with GSK core values and behaviors

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
  • ortunities 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