Site Engagement Lead Director job vacancy in GSK (Philadelphia, PA 19112)

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Company name : GSK
Location : Philadelphia, PA 19112
Position : Site Engagement Lead Director

Description :
Site Name: Home Worker – USA, USA – Pennsylvania – Philadelphia

Posted Date: Jul 25 2022
Would you like to be part of GSK’s emerging clinical leadership, accountable to ensure successful delivery of clinical trials across all therapeutic areas in both pharma and vaccines? If so, this could be an excellent opportunity to explore.

As Director of US Site Engagement , the role will be accountable
for the oversight, management and leadership of the country level activities of the Site Engagement Leads (SEL).

This role will matrix with internal and external stakeholders and ensure successful site collaboration through the Functional Service Provider (FSP) Partnerships and the monitoring organization. Accountable to ensure successful delivery of clinical trials across all therapeutic areas in both pharma and vaccines the objective of reducing cycle timelines by establishing and sustaining external site relationships. This role requires a high level of knowledge, experience and must operate independently in a highly complex, high volume, strategic market.

This position reports directly to the Clinical Operations Head and collaborates with the Leadership team in setting priorities and expectation for the SEL and FSP. This position will manage all aspects of monitoring to ensure deliverables are met within the appropriate expectations and quality standards.

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

Accountable for a team of Site Engagement Leads (SEL), who set up innovative and efficient site partnerships, by providing coaching and mentoring, line and performance management, evaluating capabilities and competencies and identifying and coordinating implementation of personal development plans. Ensures functional resource management and workload allocation is adequate. Resolve or escalate issues that may impact site partnerships.
Responsible for overseeing growth in site relationships and building GSK’s reputation as a “sponsor of choice” for top clinical trial sites.
Establishes and manages key strategic relationships with FSP and other external vendors to ensure clinical studies are appropriately resourced and executed, critical study timelines are achieved, and data/audit quality are met.
Effectively partner with FSP, working with them to:

Resolve or escalate issues that may impact study delivery or have broader impact on program delivery.
Manage resource strategies in accordance with budgetary requirements and emerging priorities to ensure studies are delivered as planned and critical study timelines are achieved.
Ensure adherence to performance metrics, delivering according to agreed timelines and quality expectations.
Ensure adherence to providing adequately trained personnel.

Work closely with SEL, FSP and with all members of the LOC Clinical Operations Department to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. If applicable, assist with audits/inspections of local clinical operations department and study/sites in the country.
In collaboration with Clinical Operation Head and Local/Regional Risk and Management Monitoring identifies management monitoring process checks linked with monitoring activities that require inclusion in the local quality plan.
Responsible for standardizing processes, identifying and sharing best practices and representing the SEL and FSP on internal, external and cross functional process improvement teams. Provide strategic input for operational excellence, process efficiency and trial delivery both internally and externally.
Co-ordinates and collaborates, as appropriate, with relevant country and/or central teams for determining feasibility of conducting protocols with reference to patient populations, study complexity, and relevant resource. Maintains oversight of selection of suitable hospitals/clinics/investigators
On an ongoing basis, effectively manage complex situations relating to change, ensures issues are addressed and that effective study team interaction takes place.
Collaborate, communicate and resolve key operational issues with matrix partners at the local, regional and global level.
Participate as a member of the US GMASE LT, representing SEL and monitoring activities, and inputting into the US GMASE strategy .
Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring techniques and capabilities. Serves as expert in ICH GCP and GSK written standards for SEL and FSP Partners.
Responsible for recruitment and training of GSK permanent staff.
Ability to lead a functionally diverse team, remotely.
Available and willing to travel as job requires.

Why you?

Basic Qualifications:

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

University Scientific degree or equivalent with line and Project Management experience. Any general science degree e.g. life science, medicine, clinical research degree, pharmacy, etc.
8+ years of experience in clinical operations required (prior monitoring experience), 5+ years of line management experience in a complex environment, experience in all stages of study lifecyle (start-up, recruitment and close-out) and across all phases. Has excellent understanding of clinical development and people management.
Solid understanding of R&D and drug development process across multiple therapy areas including pharmaceuticals and vaccines.
Demonstrated ability to stragetically manage clinical resources and activities including multiple products or indications.
Good understanding of and experience in project management. Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
Excellent leadership skills with demonstrated ability to build and maintain highly efficient and performing teams in complex environments
Excellent verbal and written communication, negotiation, presentations and relationship skills to drive business performance.
Business acumen and demonstrated ability to think strategically, quickly appreciate the differing perspectives in a given situation and achieve a win-win outcome .
Has extensive knowledge of local regulations, IND/ICH GCP guidelines and GSK written standards.

Preferred Qualifications:

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

Solid experience in matrix management
Optimization of processes experiences
Good / very good knowledge of local regulations and GCP
Previous experience with supervision of Master Service Agreement
A very good knowledge of the medical environment and organizations to identify the opportunities to develop efficient partnerships
A knowledge and experience of project management is required to be able to conduct a project from end to end, ideally using Agile methodologies
Proven experience to implement change is required to initiate and accompany the change, and to help the local team to adapt themselves to new environments and new Ways of Working.
A successful experience in designing, creating, developing and monitoring new and innovative projects is required to prove the ability to build from nothing and to be creative.

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:

This role requires working in a highly matrixed environment with internal and external customers based locally, regionally and globally. Customer service is a focus, as the role requires interaction with other GSK business areas e.g. central study teams, business system owners, LOC clinical staff and external stakeholders, investigators and site staff, vendors etc.
Negotiation skills required both internally and externally to ensure maximum value from vendors across studies and/or programs. Represents GSK effectively with external organizations and/or has demonstrated effective presentation abilities to deliver key messages to audience members.
Collaborative leadership style that proactively encourages empowerment with individuals/team to deliver the business objectives. Excellent people management skills including developing, mentoring and coaching others. Maintains enthusiasm, motivation and commitment to the team.
Good networking skills with internal partners and contacts within other GSK business units to contribute to the design and successful delivery of studies/programs.
A variety of problems (simple and highly complex) can occur during a clinical study. You will recognize and react to changes that impact a study and/or program or practices and demonstrate a track record in quality decision-making and problem resolution. Contributing to solutions to manage study/program challenges and opportunities; suggesting new ways to apply existing knowledge.
Confidence in working in an environment that is constantly evolving with new processes, tools and systems, internally and externally. Understands and effectively utilizes change management tools and approaches.


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