Executive Clinical Operations & Regulatory Affairs

Vsupport; Gurugram District; Presencial; INR 600 000 - 900 000; Tempo integral

Resumo da oferta

Vsupport is seeking executives to work on clinical trial and regulatory affairs projects across their lifecycle, including new project acquisition, strategy and planning, medical writing, regulatory affairs and clinical operations. The role suits professionals who thrive in a lean, fast-paced team.

Responsibilities include coordinating project execution from site selection to close-out across multiple sites, managing relationships with investigators and regulators, preparing submissions,

Qualificações

• 3–6 years in clinical research, clinical operations, regulatory affairs or project coordination.
• Understanding of GCP, trial regulations and industry standards.
• Excellent verbal and written communication.
• Willing to work across functions and adapt to evolving project needs.
• Proficiency in MS Office (Word & Excel).

Responsabilidades

• Coordinate clinical trial and regulatory projects from initiation to close-out.
• Manage relationships with investigators, site staff, ethics committees, vendors, and partners.
• Prepare EC/IRB submissions and interface with authorities.
• Develop and review study documents and reports.
• Evolve SOPs and quality systems based on regulatory updates.
• Maintain TMF and project documents.
• Support new project strategy and budgeting.
• Plan and track timelines, milestones, and deliverables.
• Manage client interface with progress reports and expectations.

Conhecimentos

Clinical operations

Regulatory affairs

Project coordination

GCP knowledge

MS Office fluency

Formação académica

Life sciences degree

Ferramentas

MS Word

MS Excel

Descrição da oferta de emprego

Role & responsibilities

We are looking for executives to work on clinical trial & regulatory affairs projects across their lifecycle, across new project acquisition, strategy & planning, medical writing, regulatory affairs & clinical operations. The role suits professionals who enjoy working across functions and taking ownership in a lean, fast-paced team.

Job Description:

1. Coordinating clinical trial & regulatory affairs projects execution from site selection and study initiation through monitoring and close-out, across multiple sites and projects.
2. Managing relationships with investigators, site staff, ethics committees, vendors & partners.
3. Preparing and coordinating EC/IRB and regulatory submissions, and managing the interface with regulatory authorities.
4. Contributing to development and review of protocols, eCRF, study documents & reports.
5. Contributing to the evolution of SOPs, document templates & quality systems based on regulatory updates and evolving industry practices.
6. Maintaining TMF & other project documents
7. Supporting new project strategy & planning, including operational plans and budgets.
8. Planning & tracking project timelines, key milestones & deliverables.
9. Managing client interface, including regular progress reports and alignment with their requirements & expectations.

Preferred candidate profile

1. 3-6 years of experience in clinical research, in clinical operations, regulatory affairs and/or project coordination, preferably in global clinical trials. Hands-on experience across more than one area will be preferred.
2. In-depth understanding of GCP, clinical trial regulations, industry standards and contemporary practices.
3. A degree in pharmacy, medicine or life sciences.
4. Proficiency in MS Office, particularly MS Word & MS Excel.
5. Excellent verbal and written communication skills.
6. Willingness to work across functions and adapt to evolving project needs.
7. Ability to organize and prioritize workload & take initiative.