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Site Contract Leader (1 year contract) - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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  • AdresPoland,
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Site Contract Leader (1 year contract)

Nr ref.: /JOBS.pl

  • There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's PAREXEL. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.The main responsibility of the Site Contract Leader is managing the entire Clinical Site Agreement (CSA) process for a given project, including the development of the study specific CSA strategy with the Sponsor, preparation of the corresponding country specific CSA templates and country specific budgets and also negotiation of such CSAs and budgets with the individual sites located in his/her region/country. Further, the responsibilities include managing CSA activities and liaising with PL, COL and the Sponsor to ensure that the CSA start-up deliverables are met.Key responsibilities:- Act as functional Leader on projects and develop study specific CSA strategy.- Support site confidential disclosure agreements (Site CDA) negotiations, as required.- Agree and negotiate study specific generic and/or country CSA templates and, subject to the input provided by other internal areas, negotiate the country budgets with the Sponsor.- Gather relevant study information from PL/COL.- Discuss and finalize specific country CSA templates with input from Sponsor, PL and/or COL, if appropriate.- Upon Sponsor approval of the country specific template, store the final approved and complete country CSA template and country budget in PMED, along with the corresponding CSA approval form.- Arrange translations of CSA templates to local language.- Prepare and negotiate with sites the respective CSA in accordance with the CSA strategy agreed with the Sponsor, CSA turnaround timelines, CTMS tracking requirements and budget negotiation parameters.- Work within the defined "fallback" / approval parameters to manage / resolve significant CSA changes requested by the site.- Escalate changes that fall outside the documented "fall-back" parameters, if available, to the Sponsor, SCL line manager, or any other internal point of escalation, as appropriate and ensure that sufficient background information is supplied.- Proactively keep PL/COL informed about CSA progress and any issues/challenges during the CSA negotiation.- Maintain CSA negotiation status accurately tracked in CTMS.- Collect CSA signatures.- File fully executed CSA.- Maintain comprehensive language tracker.- Early recognition of areas of potential problems and formulate contingency plans.- Participate in client, investigator and team meetings, as required.- Maintain and assure quality of work generated.- Prioritize effectively and respond to urgent requests within team or sponsor lead Qualifications:- Experienced CRA, CMA, CTS or a senior person with a legal or business degree or other relevant experience, in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal) or in a comparable function in another CRO or pharmaceutical company.- Fluent English.


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