This job has expired

US Study Start Up Lead

Employer
GSK
Location
Philadelphia, Pennsylvania
Salary
Competitive
Closing date
Aug 19, 2022

View more

Discipline
Health Sciences, Medicine
Organization Type
Pharma
You need to sign in or create an account to save a job.
The Study Start Up Lead is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. The role is the accountable person and single point of accountability for the study Start Up Metrics.

This position works directly with Study Start Up Associate Director, LDL Managers, LDL, Global SSU Managers, CRO FSP (Functional Service Provider) CRA/CSA Managers in setting priorities and expectations for Study Start-Up.

Key Responsibilities
  • Accountable to lead timely Start Up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according to Country regulations, GSK SOPs and GCP
  • Serves as the operational point-of-contact between the central GSK study team, global SSU team and within-country study team for Study Start Up activities
  • Ensures that critical study timelines related to study start up activities within-country are accurately forecasted
  • Accountable for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear internal team communication and documentation
  • Accountable via the Study Start-up Coordinators for delivery of country feasibility, site selection, recruitment planning, site training and regulatory package completion
  • Facilitates communication within the clinical team (e.g. Budget and Contracts team, Clinical Supplies, Regulatory, and monitoring) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met
  • Accountable for study recruitment vendor relations and engagement including strategy for country recruitment strategy
  • Accountable for including clinical trail diversity planning in country and site feasibility and selection
  • Responsible for standardizing processes, identifying, and sharing best practices and representing his/her team on internal and cross functional process improvement teams
  • Consulted for administrative approach to PEER sites
  • Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the development of clinical research activities / investigator partnerships
  • Is the point of contact for the FSP CRO Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice
  • Accountable for managing locally all clinical operational aspects related the Regulatory Vault approach


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's in a General Science Degree (i.e. life science, medicine, clinical research, pharmacy); other degrees or no degree can be considered if work experience in clinical research is substantial enough
  • A minimum of 5 years' work experience in clinical operations


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Profound operational knowledge of clinical research with experience in all stages of study lifecycle and understanding of R&D process
  • Good written and verbal communication skills in local language and in English
  • Strong computer skills: advanced/expert level of MS Office (PowerPoint, Excel, Word and Outlook)
  • Working knowledge of current clinical trial regulation
  • Solid experience regarding management of contracts
  • Given the nature of the job and accountabilities for local execution, project management skills are required to coordinate across all deliverables and manage local study teams to meet time, cost and quality requirements.


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, rigor 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


*LI-GSK

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert