Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
Site Contract Leader (with German)Job ID 63394BR Poland - Any Region - Home Based
The main responsibility of the Site Contract Leader is to manage the entire Clinical Site Agreement (CSA) process for a number of projects. This includes the development of the study specific CSA strategy with the Sponsor, the preparation of corresponding country specific CSA templates and country specific budgets and the negotiation of such CSAs and budgets with individual sites located in his/her region/country.
Further, the responsibilities include managing CSA activities and liaising with Project Leaders, Clinical Operations Leaders and the Sponsor to ensure that the CSA start-up deliverables are met.
• 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 “fallback” 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
• 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
• 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)
• University Degree
• Relevant work experience in Contracting or Clinical Operations or in Legal (Paralegal).
• Fluency in written and spoken English and German is required; Polish and any other languages fluency would be an asset.
• Possess strong 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 in an accurate, timely manner and effectively manage multiple tasks.
• Effective time management in order to meet daily metrics or team objectives.
• 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, Word.
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