PSI CRO AG, founded in 1995, is a global clinical research organization known for its dedication to excellence in medical science and its commitment to staff, clients, and partners. With over 2,700 passionate employees worldwide, PSI focuses on delivering high-quality work and changing lives through the development of new medicines. Headquartered in Switzerland, PSI is renowned for its personalized approach to clinical trials, consistently ranking as one of the top CROs in global studies. If you’re looking for a company that values both its people and its mission, PSI CRO AG could be the perfect fit.
Responsibilities in Job
As a Study Startup Associate based in Bengaluru, you will play a crucial role in ensuring that clinical projects run efficiently and meet deadlines. Your key responsibilities will include:
- Developing and managing site-specific startup timelines to meet site activation targets.
- Regularly updating the progress of assigned projects, ensuring smooth communication between all stakeholders.
- Handling the collection, review, and submission of essential documents for ethics and regulatory approvals, including study-specific translations.
- Negotiating site budgets and contracts with clinical sites.
- Preparing site document packages for drug release.
- Maintaining tracking and filing systems to keep startup processes organized and efficient.
Qualifications
To qualify for this exciting opportunity, you must have:
- An MD, PharmD, RN, or a university/college degree in life sciences (or an equivalent combination of education and experience).
- Practical experience in clinical trial startup processes, especially with clinical sites in India.
- Experience in regulatory submissions, contract, and budget negotiations.
- Full professional proficiency in English.
- Strong organizational, communication, and relationship-building skills to effectively manage negotiations.
Skills
The ideal candidate will demonstrate:
- Expertise in regulatory submissions, ethics review, and contract negotiations.
- Ability to create and maintain startup timelines and tracking systems.
- Excellent communication skills for fostering relationships across all levels of the organization.
- A proactive attitude, attention to detail, and strong problem-solving skills.
- Fluency in English, both written and verbal.
