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
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- 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.