Position Summary: 

Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines. 

Essential functions of the job include but are not limited to:  

Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts. Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.   Ensure adherence to company policies, procedures and contracting standards.  Update relevant study team members regarding the status of contract negotiations and execution.  Establish, track, report and manage site contract metrics. Support the maintenance of contract files and databases, including contract archiving.   Assist in designing and implementing policies and procedures to affect the timely execution of contracts. Recognize where processes can be improved and take corrective action.   Other tasks as assigned. 

Qualifications: 

Minimum Required: 

Graduate, postgraduate, 4-year college degree Equivalent experience ideally in a scientific or healthcare discipline Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, vendor contracts and site Budget negotiations, but no less than 5 years’ experience. Experienced leading interactions with Study Teams and Sponsor 

Preferred: 

Bachelors in law, scientific fields, business administration or equivalent degree Excellent organizational and communication skills and attention to detail Knowledgeable on setting up Contracting Plans - Guides for CTA & Budget negotiations Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines  

Skills: 

Competencies  

Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.  Executes time-sensitive matters while maintaining accuracy and attention to detail.  Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.  Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.  Displays sound business judgment and a proactive, independent work style.   Proficient in MS Office software programs and computer applications   Handles sensitive issues with discretion.   Works well independently and cooperatively with others to achieve common goals in a virtual environment.   Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.