Are you passionate about clinical research, GCP compliance, and project management in CROs?
Novotech, a leading global Clinical Research Organization (CRO), is hiring a Project Specialist (PS) in India. This exciting role offers you the chance to work on international clinical trials, support Project Managers, and play a key role in ensuring smooth project delivery from start-up to close-out.
If you’re a life sciences graduate eager to grow your career in clinical trial operations, this could be the perfect opportunity for you.
🧩 Role Overview
The Project Specialist works closely with the Project Manager (PM) to manage project timelines, documentation, and risk mitigation activities. You’ll ensure compliance with ICH-GCP, local regulations, and client SOPs, contributing to Novotech’s mission to deliver world-class clinical research solutions.
🔍 Key Responsibilities
- Assist Project Managers with project deliverables, cost tracking, and risk management.
- Set up and maintain project plans, timelines, and study tracking systems like CTMS, eTMF, and Financial Force.
- Support regional teams on clinical studies and prepare essential study templates and tools.
- Help manage project finances – invoice tracking, report review, and monthly revenue recognition.
- Liaise with clients and alliance partners for project coordination.
- Maintain CTMS compliance by monitoring metrics, conducting gap analyses, and resolving “red flags.”
- Organize project communications, meeting materials, and minutes.
- Assist in vendor management and project start-up activities such as regulatory submissions and site activation.
- Manage the Trial Master File (TMF) and support audits as required.
- Uphold Novotech’s quality standards, policies, and SOPs in all activities.
🎓 Qualifications & Experience
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related discipline.
- 2–3 years’ experience in the clinical research industry (CRO experience preferred).
- Strong understanding of drug development, ICH-GCP, and regulatory requirements.
- Excellent communication, documentation, and organizational skills.
- Proficiency in tools like CTMS, eTMF, and Microsoft Office Suite.
💼 Why Join Novotech?
Novotech offers a dynamic, inclusive, and growth-oriented work culture with:
- Flexible working options and wellness programs.
- Paid parental leave for both parents.
- Ongoing learning and professional development support.
- Opportunities to work with a diverse global team on cutting-edge biotech and pharma projects.
- Commitment to equality, inclusion, and diversity — supporting LGBTIQ+ employees and individuals with disabilities.
