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Global Clinical Development Scientist/Manager

Company: GlaxoSmithKline
Location: Philadelphia
Posted on: July 15, 2019

Job Description:

GSK has created a global Full Service Outsourcing (FSO) Delivery group and is looking for qualified and experienced individuals to join the team as Clinical Program Leads. The FSO Delivery team has overall accountability for the clinical book of work that is placed with GSK's preferred CROs and the remit is to ensure effective oversight of this multi-therapeutic portfolio of work. We are looking individuals to join our team who are comfortable in working with CROs in the full service outsourced model and know how to provide effective oversight of the CROs. If you are collaborative, comfortable in leading matrix study teams, can think of alternative solutions and believe in the CRO outsourced model, a role of Clinical Program Lead in GSK's FSO Delivery team may be a great fit for you. Apply to learn more!

Details

This role within Full Service Outsourcing Delivery combines effective oversight principles for the execution and reporting of global studies that are outsourced to GSK's preferred CROs. The role requires individuals who have excellent communication skills, can clearly state GSK delivery expectations to the CRO project team, are comfortable to strike the right balance of oversight as opposed to micro management, know how to make inferences from KPIs and study level dashboards and can identify potential risks, as well as the ability for efficient issue resolution. The Clinical Program Leads will be the Study Accountable Person for their assigned outsourced study(s) and will provide leadership in project teams, across matrix teams, key stakeholders, and external suppliers. In this role you will also:


  • Have primary accountability for delivery of a study(s) in the FSO Delivery model and be key point of contact for GSK matrix study team members / stakeholders.
  • Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and GSK / CRO are aligned on delivery strategy.
  • Work with matrix partners to develop and manage CRO task order within project budget allocation – ensure a regular cadence of financial review between GSK / CRO teams is in place.
  • Develop and foster relationships across both GSK and CRO organizational boundaries
  • Embed a culture of empowerment and accountability for CRO to resolve study issues internally, raising to GSK by exception.
  • Foster an environment that embraces the use of CRO's processes and use of technology; encourage CRO to take more accountability for quality data delivery.
  • Provide holistic oversight of CRO - understand study contribution to program / submission.
  • Accountable to ensure that all safety / quality issues impacting subject health and wellbeing are properly escalated / reported per SOP.
  • Embed KPIs that support FSO objectives
  • Reduce cycle times - through CRO's technology and process improvements, enable superior cycle time reduction.
  • Ensure effective Quality & Risk Management Oversight.
  • Promote process improvement to support expedited study delivery and create efficiencies for ongoing / future.
  • Drive Inspection readiness- both CRO & GSK.

    Why you?

    Basic Qualifications:

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

    • Bachelor's degree in life sciences or related discipline
    • Experience in a pharmaceutical industry or CRO environment in the clinical development process
    • In depth knowledge of study management, global regulatory guidelines and ICH/GCP
    • Experience in developing study protocols, study procedures manuals, informed consent forms and clinical study reports.
    • Proven track record of working with investigators, external experts, Contract Research Organizations and vendors
    • Excellent leadership skills

      Preferred Qualifications:

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

      • Advanced degree (e.g. MS, PhD, PharmD)
      • Clinical development experience across all phases of development (I-IV).
      • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
      • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
      • Excellent influencing and negotiation skills

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

        Important notice to Employment businesses/ Agencies

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

Keywords: GlaxoSmithKline, Philadelphia , Global Clinical Development Scientist/Manager, Healthcare , Philadelphia, Pennsylvania

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