Site Contract Manager - CRO

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Responsibilities:

* Act as Contract Study Lead on allocated studies with active responsibility for the 
performance of the contract team assigned to the study, acting as a primary point of 
contact between Sponsor and study teams, determining site contract processes, delegating 
duties to staff, and providing functional oversight of site contract and budget negotiations;
* Create project-specific site contract documents, including study templates;
* Review contract queries that fall outside of agreed parameters escalated by Contract 
Specialists;
* Ensure Contract staff provide timely and accurate budget and contract review and 
execution, as well as meaningful updates in ClinTrak;
* Facilitate clear communication, evaluation, and reporting of ongoing contract negotiations 
to study teams (e.g., Clinical Trial Management, Regulatory Submissions), ensuring that 
timelines are met, delays are managed effectively, and study team and Sponsor concerns 
are addressed as appropriate;
* Provide contract support and advice related to site payments, site contracts, and other 
related documents and vendor contracts, identifying potential contractual issues, 
addressing, escalating and/or resolving such in order to minimize contractual risk to the 
organization;
* Support in the development and implementation of contract management and compliance 
initiatives;
* Line manage local or remote staff where applicable, including recruitment, training and 
development, and functional oversight of staff; and
* May be responsible for other projects and responsibilities as assigned.

Qualifications:

* Bachelor's degree, preferably in the area of Business, Life Sciences, or Law, with 4 years of
clinical research industry experience, in clinical operations with contract management 
experience, or Juris Doctorate/Advanced education in the field of law and 2 years of clinical 
research industry experience with contract management experience;
* Experience with LATAM Site Contracts required; US project experience preferred;
* Broad knowledge of clinical trial conduct, standards of Good Clinical Practice, and 
applicable regulations and laws;
* Demonstrated knowledge and ability to review and revise contracts for legal implications;
and
* Demonstrated ability to successfully motivate and collaborate with internal and external 
study team members, including Contract Specialists without direct reporting relationship.
* Fluency in English

***We kindly ask to submit CV in English
			

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