Site Contract Leader

Profile

Site Contract Leader

The candidate will 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 a comprehensive language tracker. Early recognition of areas of potential problems and formulating contingency plans. Participate in client, investigator and team meetings, as required. Maintain and assure the 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).

Additional Information

Job ID R0000004716.

Company info

PAREXEL International Corporation
Riverside Center 275 Grove St 101C
Newton
Massachusetts
United States 02466
Website : http://www.parexel.com