Global Clinical Development Scientist/Manager
Posted on: July 15, 2019
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!
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
- 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
- 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.
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
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
- 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
- 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
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
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visit GSK's Transparency Reporting For the Record site.
Keywords: GlaxoSmithKline, Philadelphia , Global Clinical Development Scientist/Manager, Healthcare , Philadelphia, Pennsylvania
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