Manager, Clinical Study Contracts Analysis (JD) Job in King Of Prussia, Pennsylvania US
Qualifications:
Bachelor Degree preferably in science/business; JD or LL.B, Member of Bar preferred. Some other qualifications include: previous clinical study experience 3-5 years; previous contract drafting and negotiation; previous Clinical Study Agreement drafting and negotiation preferred, experience with health care issues helpful; thorough understanding of contracts and their legal implications.
Responsibilities:
Think Theorem -Think Ahead! Manage assigned investigator agreement staff and services to assure that deliverables to sponsor are met on time, within budget, and in accordance with client expectations, Theorem CR standards and SOPs, and FDA/ICH guidelines and regulations. Some other responsibilities include: Manage development of template and study specific investigator agreements, alternative language, amendments, and related documents and coordinate inclusion of patient study budgets with Grants Management and Project Management in order to meet project, Sponsor, and OCR specifications; Manage the training of Agreements, Clinical Investigator Relations, Clinical Trial Services, Project Management and Clinical Monitoring staff on each project regarding use of templates and alternative language and in general through development and maintenance of working practice guidelines; Provide legal advice to OCR staff and Sponsors as necessary during study initiation (eg. CDA, CSA negotiation); Provide miscellaneous reports to OCR staff and Sponsors as necessary during the investigator agreement negotiation process and as requested.