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As Country Study Manager (CSM), you will be pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial in the U.S. The CSM leads and manages the operational implementation of within-country study delivery of US R & D Pharma Phase I-IV clinical studies within and across therapeutic areas. The CSM is accountable for within-country execution and delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, and GSK Corporate, Pharma, and local SOPs and Policies. The CSM serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRA) and other in-country staff aligned to the study.

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

  • Accountability for feasibility and site selection for assigned studies within country and overall project management of associated study activities.
  • Accountability for high quality execution/delivery of studies within country as defined by protocol & per agreed to timelines/budget.
  • Accountability for local activities required for study design and set up.
  • Proactively identifying areas at risk, develop mitigation strategies and communicating to management and central study team.
  • Demonstrating an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements
  • Demonstrating the discipline of risk-based planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics
  • Demonstrating strong knowledge and experience in project management and matrix team interactions
  • Leading and working within teams and networks across functional and geographical boundaries; leading by example to promote collaboration, effective communication and leadership in others
  • Why you?

    Basic Qualifications:

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

  • BA/BS
  • 5 years of clinical/research experience (can be in Study Management, Field Monitoring or similar)
  • Project management experience (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available); experience projecting, managing and reporting budget information
  • Preferred Qualifications:

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

  • 7 years clinical/research experience (can be in Study Management, Field Monitoring or similar)
  • Risk-based monitoring experience
  • 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
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. 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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    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.



    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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