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Contract Manager - Clinical Operations - Location: Warren NJ or Remote

Company: GSK Group of Companies
Location: Warren
Posted on: November 17, 2022

Job Description:

Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.HALEON is looking for a highly experienced clinical outsourcing professional who acts as the centralised contract management contact for clinical development.Maximising value and minimising the risk of working with external third parties through effective collaboration with our HALEON Consumer Health Clinical Development study teams and external parties, by supporting study teams' contract management with third party suppliers for Clinical Development activities.Responsible for management and execution of contracts, purchase orders and invoice process while engaging with third parties (e.g., CROs, clinical sites, HCPs, pre-clinical vendors) within the Clinical Development, Pre-Clinical & Toxicology environments according to HALEON Consumer Health relevant procedures and policies.This role will ensure execution, coordination and tracking of contract and financial information, key to successful compliance with HALEON and regulatory policies, while driving efficient use of operational resource, databases and tools.This includes accountability and oversight of the following activities in compliance with both global procedures and local requirements:

  • Act as Subject Matter Expert for contract compliance in the UK/US for Clinical Development, Pre-Clinical & Toxicology Departments.
  • Work with the Business Owner to develop both understanding of their requirements and to prepare appropriate solutions for their supplier contracting needs.
  • Draft contracts for Clinical Development, Pre-Clinical & Toxicology Departments as appropriate for all contracts executed out of the UK/US, according to information provided by the Business Owner.
  • Determine, define and review the scope of contract services required, suitability of suppliers, identification, and resolution of all business and legal issues.
  • Establish strong partnerships with the Business Owner(s) and Supplier(s) to understand contracting challenges and develop simplified, cost-effective resolutions.
  • Drive timely contract review and approval flow with Business Owners until fully executed contracts.
  • Ensure that all relevant approvals are obtained in advance and on time.
  • Ensure upload of all contracts and amendments, into appropriate repository.
  • Track contracts in relevant databases.
  • Ensure all contract pre-requisites are in place prior to contract execution in compliance with all SOP's.
  • Create, track and obtain Purchase Order (PO) approval for all Clinical Development, Pre-Clinical & Toxicology contracts in scope executed out of the UK/US.
  • Process invoices as per contract payment terms and ensure close out with finance and Business Owners at end of services.
  • Drive and ensure accurate and timely HCP/HCO payment reporting and disclosure in compliance with SP1861/SOP208655 for all Clinical Development, Pre-Clinical & Toxicology contracts in scope executed out of the UK.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
    • Develop preferred, non-preferred or niche service supplier contracts (i.e. Stand-Alone Service Agreements, Task Orders, Amendments, etc.)
    • Proactively identify and facilitate resolution of all business, legal, compliance and due diligence issues through escalation to the appropriate group within GSK CH when necessary (i.e., the study team, finance, compliance, legal or risk/due diligence, etc.)
    • Proactively liaise with functional groups to determine scope of the contract services.
    • Work in alignment with the GSK Risk Due Diligence Team to assess suitability of suppliers, apply appropriate language to contracts after Risk Assessment is completed in order to create a robust contract that minimizes Risk to GSK.
    • Serve as liaison between GSK and external suppliers on contractual issues; identify and proactively escalate concerns in a timely, manner and develop recommendations for resolution as needed.
    • Deliver ongoing contract management in a timely and appropriate manner including Changes in Scope/Amendment, conflict resolution (including developing recommendations for resolution) to reduce operational, financial and/or legal risk for that engagement or to the study.
    • Ensuring GSK policies are adhered to with respect to appropriate authorization and routing of contracts for technical approval or grant of authority ensuring that the appropriate production, distribution and document management occurs.
    • Ensure compliance with all GSK SOPs, HCP, GCP, ICH, regulatory guidelines and applicable procedures
    • Timely and accurate updating of all department databases, templates and team information.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
      • Bachelor's degree
      • 2 + years' experience in Pharmaceutical Clinical/Medical Operations Support
      • Experience and understanding of the clinical research process and regulations.
      • Experience and understanding of ICH GCP regarding study documentation
      • Experience in coordination and tracking methodologies using databases and relevant software Why HALEON Consumer Healthcare?Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.Diversity, Equity and InclusionAt Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.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/ AgenciesGSK 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.

Keywords: GSK Group of Companies, Elizabeth , Contract Manager - Clinical Operations - Location: Warren NJ or Remote, Healthcare , Warren, New Jersey

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