Clinical Development Specialist
1 week ago
As a Clinical Development Specialist at MUM Fortrea Development India Pvt Ltd, you will be responsible for adhering to standard operating procedures (SOPs) and performing various tasks with minimal guidance.
Key tasks include:
- Tracking, negotiating, and approving Site Agreements and Site Agreement templates for clinical study teams.
- Updating the departmental Site Agreement Management System (SAMS) or other required systems in a timely manner.
- Identifying and escalating issues that require review by line management.
- Confirming the quality of tasks delegated to and completed by Contracts Associate.
- Managing assigned studies with careful compliance with internal processes and procedures, or according to specified Sponsor requirements.
- Updating the departmental contract tracking system in a timely manner.
- Performing contract administration functions, including maintaining a contract tracking system and providing notice of executed contracts to relevant team members.
- Supporting line management with departmental goals, objectives, and initiatives.
- Providing regular status updates on open contracts and outstanding issues.
- Complying with corporate requirements, including inputting activities in Timesheets, conducting required training, and preparing expense reports.
- Drafting, negotiating, reviewing, and processing contracts in a commercially reasonable manner that protects Fortrea's interests.
- Negotiating contractual terms with other contracting parties in a professional manner.
- Applying knowledge of ICH GCP principles to work and following quality standard procedures.
To be successful in this role, you should have:
- A strong understanding of contract administration and clinical study management.
- Excellent communication and negotiation skills.
- Ability to work independently with minimal guidance.
- Strong organizational and time management skills.
- A passion for scientific rigor and clinical development.
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