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CSS Manager

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Mar 12, 2021

View more

Sector
Pharmaceutical, Physicians/Nurses
Organization Type
Corporate
Jobseeker Type
Professional
Global Clinical Operations vision is to “Be the best performing and trusted Global Clinical Operations organization”. Our mission is to “Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data”.

GSK is looking to recruit a CSS Manager that is tasked to p rovide leadership, oversight and manage the activities of a team of clinical support specialists (CSS), to ensure the delivery of all clinical studies, across all therapy areas (Rx and Vx), within the agreed timelines and quality standards.

This role will provide you the opportunity to lead key activities to progress your career.

Job purpose and key responsibilities:
  • Accountable to lead the local clinical support specialists to ensure timely start up, operational management, completion and delivery of all Vx and Rx clinical studies across multiple therapeutic areas to agreed timelines, quality and budget.
  • Responsibility toengagewith the FSP partner and ensurethey deliver according to agreed timelines and quality expectations.
  • Responsible to manage clinical study activities according to GSK operating standards and good clinical practice.
  • Provides training, coaching and mentoring to the team including line and performance management. Evaluates capabilities and competencies of internal staff, identifies and coordinates implementation of personal development plans. In case of insourced staff, the role holder will support study and GSK specific training, while escalating performance and development feedback to the CRO line manager.
  • Effectively manages routine and complex issues and situations independently and escalates appropriately. .
  • Responsible for standardizing processes, identifying and sharing best practices and representing study support on internal and cross functional process improvement teams.
  • Responsible for resource management and workload allocation so that studies are resourced appropriately. Responsible for recruitment and development of GSK permanent CSSs.
  • Collaborates with LOC Clinical Operations leadership team to ensure adequate resource utilization across studies assigned to the LOC, issues are addressed and effective LOC study team interaction takes place.
  • Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities.
  • Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities.
  • Ensures that critical study timelines related to CSS activities are achieved and that relevant cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for CSS to ensure productive, efficient contribution to study delivery.
  • Collaborates and communicates on key operational issues with matrix partners at the local, regional and global level.


Why you?


Basic Qualifications:

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

  • Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
  • 5+ years' experience in clinical operations is required with a preference of 2 years of line management experience.
  • Experience in clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
  • Experience with use of 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 Local Operating Company (LOC) level. Strong written and verbal communications skills are required in English and local language.
  • Experienced planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and the CSS manager needs to be able to adapt to these changes quickly and efficiently.
  • Demonstrates track record in quality decision-making and problem resolution that impacts study/program direction. Recognizing potential risks and can implement effective mitigation strategies.
  • Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.


Preferred Qualifications:

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

  • Master's degree in a science related field or equivalent


Why GSK?

Our values and expectationsare 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:

  • Confidence in working in an environment that is constantly evolving with new processes, tools and systems, internally and externally.
  • Contributes to creating solutions to manage study/program challenges and opportunities; suggests new ways to apply existing knowledge.
  • Recognizes and reacts to changes that impact a study and/or program or practices.
  • Demonstrates track record in quality decision-making and problem resolution that impacts study/program direction.
  • Understands and effectively utilizes change management tools and approaches.
  • Role requires working in a highly matrixed environment with internal and external customers both regionally and globally based.
  • Utilize negotiation skills internally and externally to ensure maximum value from vendors across studies and/or programs.
  • Proactively encourages empowerment with individuals/team to deliver the business objectives.


If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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