Study Startup Lead

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2700 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Take your career to the next level and be involved in study startup processes in India. You will oversee and manage study startup activities to ensure that PSI clinical projects start smoothly and on time in India.

Office-Based (Bangalore)

You will:

• Coordinate the startup process and provide regular updates to all functions concerned
• Collect, review, and submit documents for ethics and regulatory review and approval
• Prepare packages of site documents for drug release to clinical sites
• Develop and negotiate site contracts and budgets
• Communicate with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters till the moment of site activation
• Develop country/site-specific startup timelines and strategies and oversee startup activities in the country
• Facilitate cooperation between cross-functional teams regarding startup activities

Qualifications

• MD, PharmD, RN or university/college degree in life sciences or an equivalent combination of education, training, and experience
• Practical Clinical Trial startup experience in India, ideally as a Startup Specialist or senior 
• Full working proficiency in English
• Communication, collaboration, and problem-solving skills
• Proficiency in MS Office applications

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. Advance your career in clinical research and develop new skillsets whilst growing with the organization!