Site Contract Leader

Home Based, USAs a Site Contract Leader with Parexel, you will manage the entire Clinical Site Agreement (CSA) process for multiple projects, including the development of the study-specific CSA strategy with the Sponsor, preparation of the corresponding country-specific CSA templates and budgets, and negotiation of such CSAs and budgets with individual sites located in your region/country. Further, your responsibilities include managing CSA activities and liaising with PL, COL, and the Sponsor to ensure that the CSA start-up deliverables are met.Key AccountabilitiesAct as functional leader on projects and develop study-specific CSA strategy.Support site confidential disclosure agreement (Site CDA) negotiations, as required.Agree and negotiate study-specific generic and/or country CSA templates and 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 budget in PMED, along with the corresponding CSA approval form.Arrange translations of CSA templates to the 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 significant CSA changes requested by the site.Escalate changes that fall outside the documented "fall-back" parameters 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.Recognize areas of potential problems early 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 the team or sponsor lead.Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and PAREXEL SOPs and study-specific procedures.Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics, travel expense claims).SkillsStrong negotiation, diplomacy, team leadership skills, and excellent organizational ability.Excellent interpersonal, verbal, and written communication skills.Ability to motivate both individuals and a team.Ability to successfully work in a "virtual" team environment.Ability to complete tasks accurately and timely while managing multiple tasks.Effective time management to meet daily metrics or team objectives.Commitment to and consistent high-quality work.Ability to identify and address issues proactively in a timely manner.Ability to take initiative, work independently, and delegate.Accountability for all assigned tasks.Excellent computer and internet skills, including knowledge of MS-Office products such as Excel and Word.EducationDegree in business, legal, or life sciences, or other relevant work experience in Contracting, Clinical Operations, or in Legal (Paralegal).

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